Publications by authors named "Mary McMurran"

50 Publications

ADVANCE integrated group intervention to address both substance use and intimate partner abuse perpetration by men in substance use treatment: a feasibility randomised controlled trial.

BMC Public Health 2021 05 25;21(1):980. Epub 2021 May 25.

Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.

Background: Substance use is a risk factor for intimate partner abuse (IPA) perpetration. Delivering perpetrator interventions concurrently with substance use treatment shows promise.

Methods: The feasibility of conducting an efficacy and cost-effectiveness trial of the ADVANCE 16-week intervention to reduce IPA by men in substance use treatment was explored. A multicentre, parallel group individually randomised controlled feasibility trial and formative evaluation was conducted. Over three temporal cycles, 104 men who had perpetrated IPA towards a female (ex) partner in the past year were randomly allocated to receive the ADVANCE intervention + substance use treatment as usual (TAU) (n = 54) or TAU only (n = 50) and assessed 16-weeks post-randomisation. Participants' (ex) partners were offered support and 27 provided outcome data. Thirty-one staff and 12 men who attended the intervention participated in focus groups or interviews that were analysed using the framework approach. Pre-specified criteria assessed the feasibility of progression to a definitive trial: 1) ≥ 60% of eligible male participants recruited; 2) intervention acceptable to staff and male participants; 3) ≥ 70% of participants followed-up and 4) levels of substance use and 5) IPA perpetrated by men in the intervention arm did not increase from average baseline level at 16-weeks post-randomisation.

Results: 70.7% (104/147) of eligible men were recruited. The formative evaluation confirmed the intervention's acceptability. Therapeutic alliance and session satisfaction were rated highly. The overall median rate of intervention session attendance (of 14 compulsory sessions) was 28.6% (range 14.3-64.3% by the third cycle). 49.0% (51/104) of men and 63.0% (17/27) of their (ex) partners were followed-up 16-weeks post-randomisation. This increased to 100% of men and women by cycle three. At follow-up, neither substance use nor IPA perpetration had worsened for men in the intervention arm.

Conclusions: It was feasible to deliver the ADVANCE intervention in substance use treatment services, although it proved difficult to collect data from female (ex)partners. While some progression criteria were met, others were not, although improvements were demonstrated by the third cycle. Lessons learned will be implemented into the study design for a definitive trial of the ADVANCE intervention.

Trial Registration: ISRCTN79435190 prospectively registered 22nd May 2018.
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http://dx.doi.org/10.1186/s12889-021-11012-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8147906PMC
May 2021

Mentalization for Offending Adult Males (MOAM): study protocol for a randomized controlled trial to evaluate mentalization-based treatment for antisocial personality disorder in male offenders on community probation.

Trials 2020 Dec 7;21(1):1001. Epub 2020 Dec 7.

Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.

Background: Antisocial personality disorder (ASPD), although associated with very significant health and social burden, is an under-researched mental disorder for which clinically effective and cost-effective treatment methods are urgently needed. No intervention has been established for prevention or as the treatment of choice for this disorder. Mentalization-based treatment (MBT) is a psychotherapeutic treatment that has shown some promising preliminary results for reducing personality disorder symptomatology by specifically targeting the ability to recognize and understand the mental states of oneself and others, an ability that is compromised in people with ASPD. This paper describes the protocol of a multi-site RCT designed to test the effectiveness and cost-effectiveness of MBT for reducing aggression and alleviating the wider symptoms of ASPD in male offenders subject to probation supervision who fulfil diagnostic criteria for ASPD.

Methods: Three hundred and two participants recruited from a pool of offenders subject to statutory supervision by the National Probation Service at 13 sites across the UK will be randomized on a 1:1 basis to 12 months of probation plus MBT or standard probation as usual, with follow-up to 24 months post-randomization. The primary outcome is frequency of aggressive antisocial behaviour as assessed by the Overt Aggression Scale - Modified. Secondary outcomes include violence, offending rates, alcohol use, drug use, mental health status, quality of life, and total service use costs. Data will be gathered from police and criminal justice databases, NHS record linkage, and interviews and self-report measures administered to participants. Primary analysis will be on an intent-to-treat basis; per-protocol analysis will be undertaken as secondary analysis. The primary outcome will be analysed using hierarchical mixed-effects linear regression. Secondary outcomes will be analysed using mixed-effects linear regression, mixed-effects logistic regression, and mixed-effects Poisson models for secondary outcomes depending on whether the outcome is continuous, binary, or count data. A cost-effectiveness and cost-utility analysis will be undertaken.

Discussion: This definitive, national, multi-site trial is of sufficient size to evaluate MBT to inform policymakers, service commissioners, clinicians, and service users about its potential to treat offenders with ASPD and the likely impact on the population at risk.

Trial Registration: ISRCTN 32309003 . Registered on 8 April 2016.
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http://dx.doi.org/10.1186/s13063-020-04896-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7720544PMC
December 2020

The TinMan study: feasibility trial of a psychologically informed, audiologist-delivered, manualised intervention for tinnitus.

Int J Audiol 2020 12 17;59(12):905-914. Epub 2020 Jul 17.

National Institute for Health Research (NIHR), Nottingham Biomedical Research Centre, Nottingham, UK.

Objective: To develop a manualised psychological treatment for tinnitus that could enhance audiologist usual care, and to test feasibility of evaluating it in a randomised controlled trial.

Design: Feasibility trial, random allocation of patients to manualised treatment or treatment as usual, and mixed-methods evaluation. Senior audiologists, and adults with chronic tinnitus.

Results: Recruitment reached 63% after 6 months (feasibility pre-defined as 65%). Only nine patients (47%) were retained for the duration of the trial. Patients reported that the treatment was acceptable and helped reassure them about their tinnitus. Audiologists reported mixed feelings about the kinds of techniques that are presented to them as 'psychologically informed'. Audiologists also reported lacking confidence because the training they had was brief, and stated that more formal supervision would have been helpful to check adherence to the treatment manual.

Conclusions: The study indicate potential barriers to audiologist use of the manual, and that a clinical trial of the intervention is not yet feasible. However, positive indications from outcome measures suggest that further development work would be worthwhile. Refinements to the manual are indicated, and training and supervision arrangements to better support audiologists to use the intervention in the clinic are required. ISRCTN13059163.
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http://dx.doi.org/10.1080/14992027.2020.1788730DOI Listing
December 2020

A study protocol to assess the feasibility of conducting an evaluation trial of the ADVANCE integrated intervention to address both substance use and intimate partner abuse perpetration to men in substance use treatment.

Pilot Feasibility Stud 2020 11;6:62. Epub 2020 May 11.

9School of Health in Social Science, University of Edinburgh, 8-9 Hope Park Square, Edinburgh, 8HQ 9NW UK.

Background: Strong evidence exists that substance use is a contributory risk factor for intimate partner abuse (IPA) perpetration. Men in substance use treatment are more likely to perpetrate IPA than men from the general population. Despite this, referral pathways are lacking for this group. This trial will assess the feasibility of conducting an evaluation trial of a tailored integrated intervention to address substance use and IPA perpetration to men in substance use treatment.

Methods/design: ADVANCE is a multicentre, parallel-group individually randomised controlled feasibility trial, with a nested formative evaluation, comparing an integrated intervention to reduce IPA + substance use treatment as usual (TAU) to TAU only. One hundred and eight men who have perpetrated IPA in the past 12 months from community substance use treatment in London, the West Midlands, and the South West will be recruited. ADVANCE is a manualised intervention comprising 2-4 individual sessions (2 compulsory) with a keyworker to set goals, develop a personal safety plan and increase motivation and readiness, followed by a 12-session weekly group intervention delivered in substance use services. Men will be randomly allocated (ratio 1:1) to receive the ADVANCE intervention + TAU or TAU only. Men's female (ex) partners will be invited to provide outcome data and offered support from integrated safety services (ISS). Regular case management meetings between substance use and ISS will manage risk. Outcome measures will be obtained at the end of the intervention (approximately 4 months post-randomisation) for all male and female participants. The main objective of this feasibility trial is to estimate parameters required for planning a definitive trial including rates of consent, recruitment, and follow-up by site and group allocation. Nested formative evaluation including focus groups and in-depth interviews will explore the intervention's acceptability to participants, group facilitators, keyworkers and ISS workers. Secondary outcomes include substance use, IPA, mental health, self-management, health and social care service use, criminal justice contacts, and quality of life.

Discussion: Findings from this feasibility trial will inform the design of a multicentre randomised controlled trial evaluating the efficacy and cost-effectiveness of the ADVANCE intervention for reducing IPA and improving the well-being of female (ex)partners.

Trial Registration: ISRCTN79435190.
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http://dx.doi.org/10.1186/s40814-020-00580-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7212681PMC
May 2020

An intervention for parents with severe personality difficulties whose children have mental health problems: a feasibility RCT.

Health Technol Assess 2020 03;24(14):1-188

Department of Mental Health, Social Work and Integrative Medicine, School of Health and Education, Middlesex University, London, UK.

Background: The children of parents with severe personality difficulties have greater risk of significant mental health problems. Existing care is poorly co-ordinated, with limited effectiveness. A specialised parenting intervention may improve child and parenting outcomes, reduce family morbidity and lower the service costs.

Objectives: To develop a specialised parenting intervention for parents affected by severe personality difficulties who have children with mental health problems and to conduct a feasibility trial.

Design: A pragmatic, mixed-methods design to develop and pilot a specialised parenting intervention, Helping Families Programme-Modified, and to conduct a randomised feasibility trial with process evaluation. Initial cost-effectiveness was assessed using UK NHS/Personal Social Services and societal perspectives, generating quality-adjusted life-years. Researchers collecting quantitative data were masked to participant allocation.

Setting: Two NHS mental health trusts and concomitant children's social care services.

Participants: Parents who met the following criteria: (1) the primary caregiver of the index child, (2) aged 18-65 years, (3) have severe personality difficulties, (4) proficient in English and (5) capable of providing informed consent. Index children who met the following criteria: (1) aged 3-11 years, (2) living with index parent and (3) have significant emotional/behavioural difficulties. Exclusion criteria were (1) having coexisting psychosis, (2) participating in another parenting intervention, (3) receiving inpatient care, (4) having insufficient language/cognitive abilities, (5) having child developmental disorder, (6) care proceedings and (7) index child not residing with index parent.

Intervention: The Helping Families Programme-Modified - a 16-session intervention using structured, goal-orientated strategies and collaborative therapeutic methods to improve parenting, and child and parent functioning. Usual care - standard care augmented by a single psychoeducational session.

Main Outcome Measures: Trial feasibility - rates of recruitment, eligibility, allocation, retention, data completion and experience. Intervention acceptability - rates of acceptance, completion, alliance (Working Alliance Inventory-Short Revised) and experience. Outcomes - child (assessed via Concerns About My Child, Eyberg Child Behaviour Inventory, Child Behaviour Checklist-Internalising Scale), parenting (assessed via the Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale), parent (assessed via the Symptom Checklist-27), and health economics (assessed via the Client Service Receipt Inventory, EuroQol-5 Dimensions).

Results: The findings broadly supported trial feasibility using non-diagnostic screening criteria. Parents were mainly referred from one site (75.0%). Site and participant factors delayed recruitment. An estimate of eligible parents was not obtained. Of the 86 parents referred, 60 (69.7%) completed screening and 48 of these (80.0%) were recruited. Participants experienced significant disadvantage and multiple morbidity. The Helping Families Programme-Modified uptake (87.5%) was higher than usual-care uptake (62.5%). Trial retention (66.7%, 95% confidence interval 51.6% to 79.6%) exceeded the a priori rate. Process findings highlighted the impact of random allocation and the negative effects on retention. The Helping Families Programme-Modified was acceptable, with duration of delivery longer than planned, whereas the usual-care condition was less acceptable. At initial follow-up, effects on child and parenting outcomes were detected across both arms, with a potential outcome advantage for the Helping Families Programme-Modified (effect size range 0.0-1.3). For parental quality-adjusted life-years, the Helping Families Programme-Modified dominated usual care, and child quality-adjusted life-years resulted in higher costs and more quality-adjusted life-years. At second follow-up, the Helping Families Programme-Modified was associated with higher costs and more quality-adjusted life-years than usual care. For child quality-adjusted life-years, when controlled for baseline EuroQol-5 Dimensions, three-level version, usual care dominated the Helping Families Programme-Modified. No serious adverse events were reported.

Conclusion: The Helping Families Programme-Modified is an acceptable specialised parenting intervention. Trial methods using non-diagnostic criteria were largely supported. For future work, a definitive efficacy trial should consider site selection, recruitment methods, intervention efficiency and revised comparator condition.

Trial Registration: Current Controlled Trials ISRCTN14573230.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 14. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta24140DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7103915PMC
March 2020

Structured Psychological Support for people with personality disorder: feasibility randomised controlled trial of a low-intensity intervention.

BJPsych Open 2020 Mar 2;6(2):e25. Epub 2020 Mar 2.

Clinical Psychology, Cambridgeshire and Peterborough NHS Foundation Trust, UK.

Background: National guidance cautions against low-intensity interventions for people with personality disorder, but evidence from trials is lacking.

Aims: To test the feasibility of conducting a randomised trial of a low-intensity intervention for people with personality disorder.

Method: Single-blind, feasibility trial (trial registration: ISRCTN14994755). We recruited people aged 18 or over with a clinical diagnosis of personality disorder from mental health services, excluding those with a coexisting organic or psychotic mental disorder. We randomly allocated participants via a remote system on a 1:1 ratio to six to ten sessions of Structured Psychological Support (SPS) or to treatment as usual. We assessed social functioning, mental health, health-related quality of life, satisfaction with care and resource use and costs at baseline and 24 weeks after randomisation.

Results: A total of 63 participants were randomly assigned to either SPS (n = 33) or treatment as usual (n = 30). Twenty-nine (88%) of those in the active arm of the trial received one or more session (median 7). Among 46 (73%) who were followed up at 24 weeks, social dysfunction was lower (-6.3, 95% CI -12.0 to -0.6, P = 0.03) and satisfaction with care was higher (6.5, 95% CI 2.5 to 10.4; P = 0.002) in those allocated to SPS. Statistically significant differences were not found in other outcomes. The cost of the intervention was low and total costs over 24 weeks were similar in both groups.

Conclusions: SPS may provide an effective low-intensity intervention for people with personality disorder and should be tested in fully powered clinical trials.
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http://dx.doi.org/10.1192/bjo.2020.7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7176836PMC
March 2020

Randomised feasibility trial of the helping families programme-modified: an intensive parenting intervention for parents affected by severe personality difficulties.

BMJ Open 2020 02 6;10(2):e033637. Epub 2020 Feb 6.

Department of Mental Health, Middlesex University, London, UK.

Background: Specialist parenting intervention could improve coexistent parenting and child mental health difficulties of parents affected by severe personality difficulties.

Objective: Conduct a feasibility trial of Helping Families Programme-Modified (HFP-M), a specialist parenting intervention.

Design: Pragmatic, mixed-methods trial, 1:1 random allocation, assessing feasibility, intervention acceptability and outcome estimates.

Settings: Two National Health Service health trusts and local authority children's social care.

Participants: Parents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent. Child: (i) 3 to 11 years, (ii) living with index parent and (iii) significant emotional/behavioural difficulties.

Intervention: HFP-M: 16-session home-based intervention using parenting and therapeutic engagement strategies. Usual care: standard care augmented by single psychoeducational parenting session.

Outcomes: Primary feasibility outcome: participant retention rate.

Secondary Outcomes: (i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised). Primary clinical outcome: child behaviour (Eyberg Child Behaviour Inventory).

Secondary Outcomes: child mental health (Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27). Quantitative data were collected blind to allocation.

Results: Findings broadly supported non-diagnostic selection criterion. Of 48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later. Participant retention exceeded a priori rate (HFP-M=18; Usual care=14; 66.7%, 95% CI 51.6% to 79.6%). HFP-M was acceptable, with delivery longer than planned. Usual care had lower alliance rating. Child and parenting outcome effects detected across trial arms with potential HFP-M advantage (effect size range: 0.0 to 1.3).

Conclusion: HFP-M is an acceptable and potentially effective specialist parenting intervention. A definitive trial is feasible, subject to consideration of recruitment and retention methods, intervention efficiency and comparator condition. Caution is required in interpretation of results due to reduced sample size. No serious adverse events reported.

Trial Registration Number: ISRCTN14573230.
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http://dx.doi.org/10.1136/bmjopen-2019-033637DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7045220PMC
February 2020

Interventions to Reduce Intimate Partner Violence Perpetration by Men Who Use Substances: A Systematic Review and Meta-Analysis of Efficacy.

Trauma Violence Abuse 2019 Nov 11:1524838019882357. Epub 2019 Nov 11.

National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.

Introduction: Despite the high prevalence of intimate partner violence (IPV) perpetration by men who use substances, limited evidence exists about how best to reduce IPV among this group.

Method: A systematic narrative review with meta-analysis determined the effectiveness of interventions to reduce IPV by men who use substances. Inclusion criteria were randomized and nonrandomized controlled trials; adult heterosexual male IPV perpetrators where at least 60% of participants were alcohol and/or drug users; the intervention targeted IPV with or without targeting substance use (SU); outcomes included perpetrator and/or victim reports of IPV, SU, or both. Methodological quality was assessed.

Results: Nine trials ( = 1,014 men) were identified. Interventions were grouped into (1) integrated IPV and SU interventions ( = 5), (2) IPV interventions with adjunct SU interventions ( = 2), and (3) stand-alone IPV interventions ( = 2). Cognitive behavioral and motivational interviewing therapies were the most common approaches. Data from individual trials showed a reduction in SU outcomes in the short term (≤3months; = 2 trials) and IPV perpetration at different time points ( = 3 trials) for interventions compared with treatment as usual (TAU). Meta-analysis with integrated IPV and SU interventions showed no difference in SU ( = 3 trials) or IPV outcomes ( = 4 trials) versus SU TAU.

Conclusions: Little evidence exists for effective interventions for male IPV perpetrators who use substances. Outcomes in integrated interventions were not superior to TAU in meta-analysis. Future trials should consider the nature of the relationship between IPV and SU in intervention design, duration of intervention, and type and timing of outcome measures. .
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http://dx.doi.org/10.1177/1524838019882357DOI Listing
November 2019

Gaps in measures of adverse outcomes relating to psychological interventions.

Crim Behav Ment Health 2019 02 10;29(1):1-6. Epub 2019 Jan 10.

Division of Psychiatry, University of Edinburgh, Edinburgh, UK.

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http://dx.doi.org/10.1002/cbm.2100DOI Listing
February 2019

Psychological Support for Personality (PSP) versus treatment as usual: study protocol for a feasibility randomized controlled trial of a low intensity intervention for people with personality disorder.

Trials 2018 Oct 10;19(1):547. Epub 2018 Oct 10.

Personality Disorder Research Unit, Centre for Psychiatry, Imperial College London, London, UK.

Background: Previous research has demonstrated the clinical effectiveness of long-term psychological treatment for people with some types of personality disorder. However, the high intensity and cost of these interventions limit their availability. Lower-intensity interventions are increasingly being offered to people with personality disorder, but their clinical and cost effectiveness have not been properly tested in experimental studies. We therefore set out to develop a low intensity intervention for people with personality disorder and to test the feasibility of conducting a randomized controlled trial to compare the clinical effectiveness of this intervention with that of treatment as usual (TAU).

Methods: A two-arm, parallel-group, single-blind, randomized controlled trial of Psychological Support for Personality (PSP) versus TAU for people aged over 18 years, who are using secondary care mental health services and have personality disorder. We will exclude people with co-existing organic or psychotic mental disorders (dementia, bipolar affective disorder, delusional disorder, schizophrenia, schizoaffective disorder, or schizotypal disorder), those with cognitive or language difficulties that would preclude them from providing informed consent or compromise participation in study procedures, and those who are already receiving psychological treatment for personality disorder. Participants will be randomized via a remote system in a ratio of PSP to TAU of 1:1. Randomization will be stratified according to the referring team and gender of the participant. A single follow-up assessment will be conducted by masked researchers 24 weeks after randomization to assess mental health (using the Warwick and Edinburgh Well-Being Schedule), social functioning (using the Work and Social Adjustment Scale), health-related quality of life (EQ-5D-5 L), incidence of suicidal behavior, satisfaction with care (Client Satisfaction Questionnaire), and resource use and costs using a modified version of the Adult Service Use Schedule. In addition to this, each participant will be asked to complete the patient version of the Clinical Global Impression Scale. Feasibility and acceptability will primarily be judged by study recruitment rate and engagement and retention in treatment. The analysis will focus principally on descriptive data on the rate of recruitment, characteristics of participants, attrition, adherence to therapy, and follow-up. We will explore the distribution of study outcomes to investigate assumptions of normality in order to plan the analysis and sample size of a future definitive trial.

Discussion: Most people with personality disorder do not currently receive evidence-based interventions. While a number of high intensity psychological treatments have been shown to be effective, there is an urgent need to develop effective low intensity approaches to help people unable to use existing treatments. PSP is a low intensity intervention for individuals, which was developed following extensive consultation with users and providers of services for people with personality disorder. This study aims to examine the feasibility of a randomized trial of PSP compared to TAU for people with personality disorder.

Trial Registration: ISRCTN Registry, ISRCTN14994755 . Registered on 18 July 2017.
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http://dx.doi.org/10.1186/s13063-018-2920-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6180621PMC
October 2018

Feasibility trial of a psychoeducational intervention for parents with personality difficulties: The Helping Families Programme.

Contemp Clin Trials Commun 2017 Dec;8:67-74

Department of Mental Health, Social Work and Integrative Medicine, School of Health and Education, Middlesex University, The Burroughs, London, NW4 4BT, UK.

The Helping Families Programme is a psychoeducational parenting intervention that aims to improve outcomes and engagement for parents affected by clinically significant personality difficulties. This is achieved by working collaboratively with parents to explore ways in which their emotional and relational difficulties impact on parenting and child functioning, and to identify meaningful and realistic goals for change. The intervention is delivered via one-to-one sessions at weekly intervals over a period of 16 weeks. This protocol describes a two-arm parallel RCT in which consenting parents are randomly allocated in a 1:1 ratio to either the Helping Families Programme plus the usual services that the parent may be receiving from their mental health and/or social care providers, or to standard care (usual services plus a brief parenting advice session). The primary clinical outcome will be child behaviour. Secondary clinical outcomes will be child and parental mental health, parenting satisfaction, parenting behaviour and therapeutic alliance. Health economic measures will be collected on quality of life and service use. Outcome measures will be collected at the initial assessment stage, after the intervention is completed and at 6-month follow-up by research staff blind to group allocation. Trial feasibility will be assessed using rates of trial participation at the three time points and intervention uptake, attendance and retention. A parallel process evaluation will use qualitative interviews to ascertain key-workers' and parent participants' experiences of intervention delivery and trial participation. The results of this feasibility study will determine the appropriateness of proceeding to a full-scale trial.
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http://dx.doi.org/10.1016/j.conctc.2017.08.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5703694PMC
December 2017

Patients' and Clinicians' Views of the Psychological Components of Tinnitus Treatment That Could Inform Audiologists' Usual Care: A Delphi Survey.

Ear Hear 2018 Mar/Apr;39(2):367-377

National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham, United Kingdom.

Objectives: The aim of this study was to determine which components of psychological therapies are most important and appropriate to inform audiologists' usual care for people with tinnitus.

Design: A 39-member panel of patients, audiologists, hearing therapists, and psychologists completed a three-round Delphi survey to reach consensus on essential components of audiologist-delivered psychologically informed care for tinnitus.

Results: Consensus (≥80% agreement) was reached on including 76 of 160 components. No components reached consensus for exclusion. The components reaching consensus were predominantly common therapeutic skills such as Socratic questioning and active listening, rather than specific techniques, for example, graded exposure therapy or cognitive restructuring. Consensus on educational components to include largely concerned psychological models of tinnitus rather than neurophysiological information.

Conclusions: The results of this Delphi survey provide a tool to develop audiologists' usual tinnitus care using components that both patients and clinicians agree are important and appropriate to be delivered by an audiologist for adults with tinnitus-related distress. Research is now necessary to test the added effects of these components when delivered by audiologists.
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http://dx.doi.org/10.1097/AUD.0000000000000492DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5839700PMC
March 2019

Processes of change in an offender personality disorder pathway prison progression unit.

Crim Behav Ment Health 2017 Jul;27(3):254-264

Delight Training Ltd., Macclesfield, UK.

Background: In England, the National Offender Management Service and the NHS have come together to try and improve management and treatment of offenders with personality disorder by developing a pathways approach to assist high-risk male offenders with severe personality disorder.

Aim: The aim of the study is to investigate service user and staff perceptions of change in this pathway.

Methods: Semi-structured interviews were conducted with 16 prisoners and 16 staff in one unit in a London-based personality disorder pathway. The four core questions were as follows: (1) what changes do you think have occurred?; (2) what do you think helped make these changes?; (3) how do you think this helped change?; and (4) what hindered positive change? Thematic analysis was applied to the narratives.

Results: Prisoners and staff separately reported similar changes, each observing that prisoners became less anti-authority, improved their self-understanding, developed feelings of self-worth and increased their optimism about change. There was similar consensus on what they thought had brought about change - primarily development of trusting relationships. These allowed a psychological perspective on understanding prisoners' behaviour. Maintenance of this approach was seen as demanding, with barriers including 'security restrictions' curtailing purposeful activities, visits and community contact and 'stigmatising beliefs about personality disorder' in the wider prison.

Implications For Practice: Findings suggest that shared goals and progress are achievable. Difficulties in sustaining these will require a range of solutions, but wider support from the prison is essential to containing hostility to such prisoners and specialised work and ensuring the provision of purposeful activity. Copyright © 2017 John Wiley & Sons, Ltd.
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http://dx.doi.org/10.1002/cbm.2032DOI Listing
July 2017

A psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (Tin Man study).

Pilot Feasibility Stud 2017 15;3:24. Epub 2017 May 15.

National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Ropewalk House, 113 The Ropewalk, Nottingham, NG1 5DU UK.

Background: Chronic tinnitus is a common incurable condition often associated with depression, anxiety, insomnia and reduced quality of life. Within National Health Service (NHS) audiology in the United Kingdom (UK), no standard protocol currently exists for the treatment of tinnitus. Counselling is only available in less than half of audiology departments, and there is no agreed standard for what constitutes tinnitus counselling. There is substantial evidence from systematic reviews for the clinical benefit of cognitive behaviour therapy (CBT) for tinnitus delivered by clinical psychologists or psychiatrists, but no studies have sufficiently evidenced the NHS model of tinnitus care where management is increasingly being delivered by audiology professionals. In a pilot randomised controlled trial (RCT), this study aims to evaluate the feasibility of comparing a psychologically informed guidance manual developed to support audiologist management of tinnitus with usual treatment.

Methods/design: Phase 1 consisted of three development stages: (1) a scoping review to generate a comprehensive set of tinnitus counselling components, (2) a Delphi survey involving expert patients ( = 18) and clinicians ( = 21) to establish consensus on the essential core attributes of tinnitus counselling, and (3) incorporation of these elements into a manualised care protocol. In phase 2, following training in a dedicated workshop, the manualised intervention will be delivered by three experienced audiologists across three different sites. Patients ( = 30) will be randomly allocated to receive either (1) psychologically informed management from an audiologist trained to deliver the manualised intervention or (2) treatment as usual (TAU) from an audiologist who has not received this training. Quantitative outcome measures will be administered at baseline, discharge and 6-month follow-up. Qualitative interviews with participating patients and clinicians will be conducted to gather perspectives on the feasibility and acceptability of the manualised intervention.

Discussion: The feasibility of proceeding to a definitive RCT will be assessed via compliance with the manual, willingness to be randomised, number of eligible participants, rate of recruitment, retention and collection of quantitative outcome measures. This research offers an important first step to an evidence-based, standardised and accessible approach to tinnitus care.

Trial Registration: ISRCTN13059163. Date of registration: 6 May 2016.
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http://dx.doi.org/10.1186/s40814-017-0137-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5430602PMC
May 2017

Psychoeducation and Problem Solving (PEPS) Therapy for Adults With Personality Disorder: A Pragmatic Randomized-Controlled Trial.

J Pers Disord 2017 12 17;31(6):810-826. Epub 2017 May 17.

Centre for Mental Health, Imperial College London, UK.

We compared psychoeducation and problem solving (PEPS) therapy against usual treatment in a multisite randomized-controlled trial. The primary outcome was social functioning. We aimed to recruit 444 community-dwelling adults with personality disorder; however, safety concerns led to an early cessation of recruitment. A total of 154 people were randomized to PEPS and 152 to usual treatment. Follow-up at 72 weeks was completed for 68%. PEPS therapy was no more effective than usual treatment for improving social functioning (adjusted difference in mean Social Functioning Questionnaire scores = -0.73; 95% CI [-1.83, 0.38]; p = 0.19). PEPS therapy is not an effective treatment for improving social functioning of adults with personality disorder living in the community.
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http://dx.doi.org/10.1521/pedi_2017_31_286DOI Listing
December 2017

Treatment of alcohol-related violence: Integrating evidence from general violence and IPV treatment research.

Authors:
Mary McMurran

Drug Alcohol Rev 2017 Jan 21;36(1):13-16. Epub 2017 Jan 21.

Institute of Mental Health, University of Nottingham, Triumph Road, Nottingham, UK.

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http://dx.doi.org/10.1111/dar.12492DOI Listing
January 2017

Psychoeducation with problem-solving (PEPS) therapy for adults with personality disorder: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manualised intervention to improve social functioning.

Health Technol Assess 2016 07;20(52):1-250

Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.

Background: If effective, less intensive treatments for people with personality disorder have the potential to serve more people.

Objectives: To compare the clinical effectiveness and cost-effectiveness of psychoeducation with problem-solving (PEPS) therapy plus usual treatment against usual treatment alone in improving social problem-solving with adults with personality disorder.

Design: Multisite two-arm, parallel-group, pragmatic randomised controlled superiority trial.

Setting: Community mental health services in three NHS trusts in England and Wales.

Participants: Community-dwelling adults with any personality disorder recruited from community mental health services.

Interventions: Up to four individual sessions of psychoeducation, a collaborative dialogue about personality disorder, followed by 12 group sessions of problem-solving therapy to help participants learn a process for solving interpersonal problems.

Main Outcome Measures: The primary outcome was measured by the Social Functioning Questionnaire (SFQ). Secondary outcomes were service use (general practitioner records), mood (measured via the Hospital Anxiety and Depression Scale) and client-specified three main problems rated by severity. We studied the mechanism of change using the Social Problem-Solving Inventory. Costs were identified using the Client Service Receipt Inventory and quality of life was identified by the European Quality of Life-5 Dimensions questionnaire. Research assistants blinded to treatment allocation collected follow-up information.

Results: There were 739 people referred for the trial and 444 were eligible. More adverse events in the PEPS arm led to a halt to recruitment after 306 people were randomised (90% of planned sample size); 154 participants received PEPS and 152 received usual treatment. The mean age was 38 years and 67% were women. Follow-up at 72 weeks after randomisation was completed for 62% of participants in the usual-treatment arm and 73% in the PEPS arm. Intention-to-treat analyses compared individuals as randomised, regardless of treatment received or availability of 72-week follow-up SFQ data. Median attendance at psychoeducation sessions was approximately 90% and for problem-solving sessions was approximately 50%. PEPS therapy plus usual treatment was no more effective than usual treatment alone for the primary outcome [adjusted difference in means for SFQ -0.73 points, 95% confidence interval (CI) -1.83 to 0.38 points; p = 0.19], any of the secondary outcomes or social problem-solving. Over the follow-up, PEPS costs were, on average, £182 less than for usual treatment. It also resulted in 0.0148 more quality-adjusted life-years. Neither difference was statistically significant. At the National Institute for Health and Care Excellence thresholds, the intervention had a 64% likelihood of being the more cost-effective option. More adverse events, mainly incidents of self-harm, occurred in the PEPS arm, but the difference was not significant (adjusted incidence rate ratio 1.24, 95% CI 0.93 to 1.64).

Limitations: There was possible bias in adverse event recording because of dependence on self-disclosure or reporting by the clinical team. Non-completion of problem-solving sessions and non-standardisation of usual treatment were limitations.

Conclusions: We found no evidence to support the use of PEPS therapy alongside standard care for improving social functioning of adults with personality disorder living in the community.

Future Work: We aim to investigate adverse events by accessing centrally held NHS data on deaths and hospitalisation for all PEPS trial participants.

Trial Registration: Current Controlled Trials ISRCTN70660936.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 52. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta20520DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4967813PMC
July 2016

The need for evidence-based responses to address intimate partner violence perpetration among male substance misusers.

Crim Behav Ment Health 2015 Dec;25(4):233-8

Glasgow Caledonian University, School of Health and Life Sciences, Glasgow, UK.

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http://dx.doi.org/10.1002/cbm.1980DOI Listing
December 2015

Development of a self-report measure of social functioning for forensic inpatients.

Int J Law Psychiatry 2015 Mar-Apr;39:72-6. Epub 2015 Feb 7.

Institute of Mental Health, University of Nottingham, Triumph Road, Nottingham NG7 2TU, UK.

Despite increasing interest in the measurement of social functioning in people with personality disorder, there are currently no social functioning measures specifically for forensic or other inpatients with a diagnosis of personality disorder. This paper describes the development and validation of the Hospital Social Functioning Questionnaire (HSFQ), a self-report measure of social functioning for forensic inpatients. A sample of fifty four male inpatients in a forensic personality disorder treatment unit completed the HSFQ and a range of measures indicative of social functioning, namely self-report measures of psychological wellbeing and symptoms, recorded incidents of self-harm and aggression. Clinicians' ratings of global functioning, and clinically assessed personality disorder severity were also collected. The HSFQ showed good internal consistency and test-retest reliability, good concurrent validity with self-report measures of personality pathology, other symptoms and psychological wellbeing, but only a moderate correlation with clinician-rated global functioning and with frequency of self-harm and aggressive behavior. These results suggest that the HSFQ is a more focused measure of social functioning than the Global Assessment of Functioning (GAF), which conflates social functioning with self harm and aggressive behavior. The HSFQ is a potentially useful assessment of social functioning in secure and other inpatient settings.
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http://dx.doi.org/10.1016/j.ijlp.2015.01.023DOI Listing
February 2016

A survey of how clinicians in forensic personality disorder services engage their service users in treatment.

J Forens Psychiatry Psychol 2013 Dec;24(6):772-787

Institute of Mental Health, University of Nottingham, University of Nottingham Innovation Park, UK.

Non-completion is a significant problem in treatments for personality disorder (PD), and is associated with poorer outcomes. Clinicians routinely attend to engagement issues with people diagnosed with PD and so we accessed their views about the techniques they used to facilitate treatment engagement with service users with PD. Twenty-three clinicians from a range of disciplines were asked how they defined treatment engagement, what they thought were the causes of treatment engagement problems in people with PD, and what techniques or strategies they used to enhance engagement of people with PD. Data were analysed using inductive thematic analysis. Staff working with people with PD have broad views on the factors that are implicated in treatment engagement for their client group. Consequently, the techniques they use to engage service users are wide-ranging, addressing issues to do with services, individuals, therapies and therapists. Given the limited published data thus far, the suggestions generated may be of value to other practitioners in improving service user engagement.
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http://dx.doi.org/10.1080/14789949.2013.862292DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4156857PMC
December 2013

The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials.

Trials 2014 Aug 27;15:335. Epub 2014 Aug 27.

Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham NG7 2TU, UK.

Background: There is a concern in the literature that harm from interventions is insufficiently documented in clinical trials in general, and in those assessing psychological treatments in particular. A recent decision by a trial steering committee to stop recruitment into a randomized controlled trial (RCT) of a psychological intervention for personality disorder led to an investigation of the recording of harm in trials funded by the National Institute for Health Research (NIHR).

Methods: The protocols and final reports of all 82 NIHR trials funded between 1995 and 2013 were examined for the reporting of adverse events. These were subdivided by category of intervention.

Results: None of the psychological intervention trials mentioned the occurrence of an adverse event in their final report. Trials of drug treatments were more likely to mention adverse events in their protocols compared with those using psychological treatments. When adverse events were mentioned, the protocols of psychological interventions relied heavily on severe adverse events guidelines from the National Research Ethics Service (NRES), which were developed for drug rather than psychological interventions and so may not be appropriate for the latter.

Conclusions: This survey supported the belief that the reporting of adverse events in psychological treatments is weak and the criteria used may not be appropriate. Recommendations are made as to how current practice might be improved.
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http://dx.doi.org/10.1186/1745-6215-15-335DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4152561PMC
August 2014

A treatment goal checklist for people with personality disorder.

Personal Ment Health 2013 Nov 3;7(4):298-306. Epub 2013 Jun 3.

Cwm Taf NHS Trust, Psychological Therapies, Wales, UK.

Background: Agreement between client and therapist on treatment goals has been consistently linked with improved treatment outcomes. Having clear and collaborative goals may be particularly important when working with clients diagnosed with personality disorders who are often difficult to engage and test the boundaries of therapy. This paper outlines the development of a personality disorder treatment goal checklist aimed at helping clients and therapists to identify and prioritize their goals for therapy.

Method: The checklist was developed using self-reported problems of the first 90 participants randomized into the psychoeducation and problem solving (PEPS) trial. Problems were coded and categorized into problem areas. The checklist was viewed by two service users who gave suggestions for improvements.

Results: The final checklist consists of 161 items in 16 problem areas.

Conclusions: The checklist may provide a clinically useful tool for working with this client group.
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http://dx.doi.org/10.1002/pmh.1236DOI Listing
November 2013

An evaluation of case formulation training and consultation with probation officers.

Crim Behav Ment Health 2013 Oct;23(4):252-62

John Howard Centre, London, UK.

Background: Formulation is a core competency of mental health professionals, drawing on a variety of sources of information. In England and Wales, the current strategy for offenders with personality disorder places formulation-led management, generally by probation staff, at its core, but reliability and validity of the process remain unclear.

Aims: The first aim was to evaluate a checklist previously designed to establish quality of formulation, and the second to measure the impact of training and consultation on the ability of probation officers to formulate cases.

Methods: The inter-rater reliability, test-re-test reliability and internal consistency of the McMurran formulation checklist were calculated from the scores derived from randomised formulations completed by probation officers from fictitious case vignettes. The impact of training was measured by comparing pre- and post-training formulations of these vignettes. Practice cases formulated by probation officers at psychologist-facilitated consultation meetings over a 6-month period were used to measure the impact of consultation. All formulations were scored blind by independent experts.

Results: Inter-rater reliability, test-re-test reliability and internal consistency of the scale were all acceptable. Training and practice did not significantly improve the probation officers' formulations.

Conclusions: The purpose and utility of formulation may vary according to the context in which it is applied. Progress in developing formulation skills may depend on the nature and length of the previous experience of this skill. Future research should take account of such variance, with this scale as a potentially useful aid in monitoring progress.

Implications: The capacity for teaching formulation to probation officers could be investigated further by comparing the process with formulation development by mental health experts with previously extensive formulation experience. Formulation will probably need to be adapted to meet the needs of the context in which it is developed. The relationship between formulation and management outcome was not investigated here and would be a further important step.
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http://dx.doi.org/10.1002/cbm.1890DOI Listing
October 2013

Case formulation with offenders: what, who, where, when, why and how?

Crim Behav Ment Health 2013 Oct;23(4):227-9

Institute of Mental Health, University of Nottingham, Nottingham, NG7 2TU, UK.

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http://dx.doi.org/10.1002/cbm.1891DOI Listing
October 2013

Cost implications of treatment non-completion in a forensic personality disorder service.

Crim Behav Ment Health 2013 Dec 23;23(5):321-35. Epub 2013 Jul 23.

School of Sociology and Social Policy, University of Nottingham, Nottingham, UK; NIHR-CLAHRC-NDL, Nottingham, UK.

Background: A high proportion of individuals admitted to specialist secure hospital services for treatment of personality disorder do not complete treatment. Non-completion has been associated with poorer treatment outcomes and increased rates of recidivism and hospital readmission, when compared with individuals who do complete treatment or who do not receive treatment at all.

Aims: In this study, we sought to determine the economic consequences of non-completion of treatment, using case study data from a secure hospital sample. Both health and criminal justice service perspectives were taken into account.

Methods: Data were collected from a medium secure hospital personality disorder unit. A probabilistic decision-analytic model was constructed, using a Markov cohort simulation with 10,000 iterations. The expected cost differential between those who do and those who do not complete treatment was estimated, as was the probability of a cost differential over a 10-year post-admission time horizon.

Results: On average, in the first 10 years following admission, those who do not complete treatment go on to incur £52,000 more in costs to the National Health Service and criminal justice system than those who complete treatment. The model estimates that the probability that non-completers incur greater costs than completers is 78%.

Conclusion: It is possible that an improvement in treatment completion rates in secure hospital personality disorder units would lead to some cost savings. This might be achievable through better selection into treatment or improved strategies for engagement and retention. Our study highlights a financial cost to society of individuals discharged from secure hospital care when incompletely treated. We suggest that it could, therefore, be useful for secure hospitals to introduce routine monitoring of treatment completion.
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http://dx.doi.org/10.1002/cbm.1866DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3920639PMC
December 2013

Increasing recognition of happiness in ambiguous facial expressions reduces anger and aggressive behavior.

Psychol Sci 2013 May 26;24(5):688-97. Epub 2013 Mar 26.

School of Experimental Psychology, University of Bristol, Bristol BS8 1TU, United Kingdom.

The ability to identify emotion in other people is critical to social functioning. In a series of experiments, we explored the relationship between recognition of emotion in ambiguous facial expressions and aggressive thoughts and behavior, both in healthy adults and in adolescent youth at high risk of criminal offending and delinquency. We show that it is possible to experimentally modify biases in emotion recognition to encourage the perception of happiness over anger in ambiguous expressions. This change in perception results in a decrease in self-reported anger and aggression in healthy adults and high-risk youth, respectively, and also in independently rated aggressive behavior in high-risk youth. We obtained similar effects on mood using two different techniques to modify biases in emotion perception (feedback-based training and visual adaptation). These studies provide strong evidence that emotion processing plays a causal role in anger and the maintenance of aggressive behavior.
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http://dx.doi.org/10.1177/0956797612459657DOI Listing
May 2013

The addition of a goal-based motivational interview to treatment as usual to enhance engagement and reduce dropouts in a personality disorder treatment service: results of a feasibility study for a randomized controlled trial.

Trials 2013 Feb 17;14:50. Epub 2013 Feb 17.

Institute of Mental Health, University of Nottingham, Triumph Road, Nottingham NG7 2TU, UK.

Background: There are high rates of treatment non-completion for personality disorder and those who do not complete treatment have poorer outcomes. A goal-based motivational interview may increase service users' readiness to engage with therapy and so enhance treatment retention. We conducted a feasibility study to inform the design of a randomized controlled trial. The aims were to test the feasibility of recruitment, randomization and follow-up, and to conduct a preliminary evaluation of the effectiveness of the motivational interview.

Methods: Patients in an outpatient personality disorder service were randomized to receive the Personal Concerns Inventory plus treatment as usual or treatment as usual only. The main randomized controlled trial feasibility criteria were recruitment of 54% of referrals, and 80% of clients and therapists finding the intervention acceptable. Information was collected on treatment attendance, the clarity of therapy goals and treatment engagement.

Results: The recruitment rate was 29% (76 of 258). Of 12 interviewed at follow-up, eight (67%) were positive about the Personal Concerns Inventory. Pre-intervention interviews were conducted with 61% (23 out of 38) of the Personal Concerns Inventory group and 74% (28 out of 38) of the treatment as usual group. Participants' therapy goals were blind-rated for clarity on a scale of 0 to 10. The mean score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Over 12 weeks, the median percentage session attendance was 83.33% for the Personal Concerns Inventory group (N = 17) and 66.67% for the treatment as usual group (N = 24). Of 59 eligible participants at follow-up, the Treatment Engagement Rating scale was completed for 40 (68%). The mean Treatment Engagement Rating scale score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Of the 76 participants, 63 (83%) completed the Client Service Receipt Inventory at baseline and 34 of 59 (58%) at follow-up.

Conclusion: Shortfalls in recruitment and follow-up data collection were explained by major changes to the service. However, evidence of a substantial positive impact of the Personal Concerns Inventory on treatment attendance, clarity of therapy goals and treatment engagement, make a full-scale evaluation worth pursuing. Further preparatory work is required for a multisite trial.

Trial Registration: ClinicalTrials.Gov.UK Identifier - NCT01132976.
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http://dx.doi.org/10.1186/1745-6215-14-50DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3598789PMC
February 2013

Additional interventions to enhance the effectiveness of individual placement and support: a rapid evidence assessment.

Rehabil Res Pract 2012 22;2012:382420. Epub 2012 May 22.

Institute of Mental Health, University of Nottingham, Sir Colin Campbell Building, Triumph Road, Nottingham NG7 2TU, UK.

Topic. Additional interventions used to enhance the effectiveness of individual placement and support (IPS). Aim. To establish whether additional interventions improve the vocational outcomes of IPS alone for people with severe mental illness. Method. A rapid evidence assessment of the literature was conducted for studies where behavioural or psychological interventions have been used to supplement standard IPS. Published and unpublished empirical studies of IPS with additional interventions were considered for inclusion. Conclusions. Six published studies were found which compared IPS alone to IPS plus a supplementary intervention. Of these, three used skills training and three used cognitive remediation. The contribution of each discrete intervention is difficult to establish. Some evidence suggests that work-related social skills and cognitive training are effective adjuncts, but this is an area where large RCTs are required to yield conclusive evidence.
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http://dx.doi.org/10.1155/2012/382420DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3364687PMC
August 2012

Psycho-education with problem solving (PEPS) therapy for adults with personality disorder: a pragmatic multi-site community-based randomised clinical trial.

Trials 2011 Aug 24;12:198. Epub 2011 Aug 24.

Institute of Mental Health, University of Nottingham, Sir Colin Campbell Building, Nottingham NG7 2TU, UK.

Background: Impairment in social functioning is a key component of personality disorder. Therefore psycho-education and problem solving (PEPS) therapy may benefit people with this disorder. Psycho-education aims to educate, build rapport, and motivate people for problem solving therapy. Problem solving therapy aims to help clients solve interpersonal problems positively and rationally, thereby improving social functioning and reducing distress. PEPS therapy has been evaluated with community adults with personality disorder in an exploratory trial. At the end of treatment, compared to a wait-list control group, those treated with PEPS therapy showed better social functioning, as measured by the Social Functioning Questionnaire (SFQ). A definitive evaluation is now being conducted to determine whether PEPS therapy is a clinically and cost-effective treatment for people with personality disorder

Methods: This is a pragmatic, two-arm, multi-centre, parallel, randomised controlled clinical trial. The target population is community-dwelling adults with one or more personality disorder, as identified by the International Personality Disorder Examination (IPDE). Inclusion criteria are: Living in the community (including residential or supported care settings); presence of one or more personality disorder; aged 18 or over; proficiency in spoken English; capacity to provide informed consent. Exclusion criteria are: Primary diagnosis of a functional psychosis; insufficient degree of literacy, comprehension or attention to be able to engage in trial therapy and assessments; currently engaged in a specific programme of psychological treatment for personality disorder or likely to start such treatment during the trial period; currently enrolled in any other trial. Suitable participants are randomly allocated to PEPS therapy plus treatment as usual (TAU) or TAU only. We aim to recruit 340 men and women. The primary outcome is social functioning as measured by the SFQ. A reduction (i.e., an improvement) of 2 points or more on the SFQ at follow-up 72 weeks post-randomisation is our pre-specified index of clinically significant change. Secondary outcomes include a reduction of unscheduled service usage and an increase in scheduled service usage; improved quality of life; and a reduction in mental distress.

Discussion: PEPS therapy has potential as an economical, accessible, and acceptable intervention for people with personality disorder. The results from this randomised controlled trial will tell us if PEPS therapy is effective and cost-effective. If so, then it will be a useful treatment for inclusion in a broader menu of treatment options for this group of service users.

Trial Registration: International Standard Randomised Controlled Trial Number - ISRCTN70660936.
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http://dx.doi.org/10.1186/1745-6215-12-198DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3171716PMC
August 2011
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