Publications by authors named "Corinne Cather"

66 Publications

Relationship between cannabis use and psychotic experiences in college students.

Schizophr Res 2021 Apr 19;231:198-204. Epub 2021 Apr 19.

Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, USA.

Background: Emerging data suggest cannabis use is a component cause of psychotic disorders; however, the sequence of processes accounting for this association is poorly understood. Some clues have come from studies in laboratory settings showing that acute cannabis intoxication is associated with subclinical hallucinations and delusional thinking, i.e., "psychotic experiences". Although psychotic experiences are relatively common, those that are severe and distressing are linked to an increased risk of developing a psychotic disorder. This study aimed to investigate the association between the frequency of cannabis use and psychotic experiences in young adults.

Methods: 1034 U.S. college students completed questionnaires to assess: cannabis use in the past week, delusional ideation (Peters Delusions Inventory), hallucinations (Launay-Slade Hallucinations Scale-Extended), and depression (Beck Depression Inventory).

Results: Participants reporting higher rates of weekly cannabis use were more likely to report hallucinatory experiences and delusional ideation. The relationship between cannabis use and hallucinatory experiences, but not the relationship between cannabis use and delusional ideation, remained significant after controlling for levels of depression. Moreover, those who reported greater amounts of cannabis use had more distressing delusional ideas, that were held with more conviction.

Conclusions: Cannabis use is linked to the presence of subclinical hallucinations and delusional ideation in U.S. college students.
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http://dx.doi.org/10.1016/j.schres.2021.04.004DOI Listing
April 2021

The alliance-outcome relationship in individual psychosocial treatment for schizophrenia and early psychosis: A meta-analysis.

Schizophr Res 2021 Apr 15;231:154-163. Epub 2021 Apr 15.

Department of Psychology and Neuroscience and Behavior, Wesleyan University, Middletown, CT, USA.

The therapeutic alliance, or client-provider relationship, has been associated with better treatment engagement and outcomes for persons with schizophrenia-spectrum disorders (SSDs) and early psychosis in some studies, but not others. We conducted a meta-analysis of the research on alliance in SSDs and early psychosis across a range of interventions and outcomes. Parallel literature searches were conducted in PubMed and PsycINFO databases for articles between inception and 6/11/2020. English-language studies were included if they evaluated the relationship between alliance and a prospective outcome (treatment engagement, medication adherence, functioning, or total, positive, negative, or depressive symptoms) in an individual clinical treatment for SSDs/early psychosis and contained analyzable data. Correlations and partial correlations were meta-analyzed with random effects models to calculate mean across-study correlations and to carry out subsequent homogeneity and moderator variable analyses. Fourteen studies consisting of 2968 participants that assessed six outcomes across six psychosocial treatments were included. Results indicated that better client-rated (r = 0.20) and other-rated (i.e., provider- or observer-rated; r = 0.25) alliance were associated with better treatment engagement. Treatment type and sample race/ethnicity, but not age, gender, or timing of alliance rating moderated the association between other-rated alliance and engagement. Further, better other-rated alliance was related to improvements in positive (r = -0.14) and negative (r = -0.22) symptoms. A strong therapeutic alliance is important for both engaging clients with SSDs and early psychosis in treatment and facilitating improvements in positive and negative symptoms. Delivery and monitoring of treatments for this population should include assessment of the therapeutic alliance from multiple perspectives.
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http://dx.doi.org/10.1016/j.schres.2021.04.002DOI Listing
April 2021

Effect of citalopram on hippocampal volume in first-episode schizophrenia: Structural MRI results from the DECIFER trial.

Psychiatry Res Neuroimaging 2021 Apr 7;312:111286. Epub 2021 Apr 7.

Department of Psychiatry, NYU Langone Health, 1 Park Avenue, New York, NY 10016, United States of America; Nathan Kline Institute for Psychiatric Research, 140 Old Orangeburg Road, Orangeburg, NY 10962, United States of America. Electronic address:

Hippocampal volume loss is prominent in first episode schizophrenia (FES) and has been associated with poor clinical outcomes and with BDNF genotype; antidepressants are believed to reverse hippocampal volume loss via release of BDNF. In a 12-month, placebo-controlled add-on trial of the antidepressant, citalopram, during the maintenance phase of FES, negative symptoms were improved with citalopram. We now report results of structural brain imaging at baseline and 6 months in 63 FES patients (34 in citalopram group) from the trial to assess whether protection against hippocampal volume loss contributed to improved negative symptoms with citalopram. Hippocampal volumetric integrity (HVI) did not change significantly in the citalopram or placebo group and did not differ between treatment groups, whereas citalopram was associated with greater volume loss of the right CA1 subfield. Change in cortical thickness was associated with SANS change in 4 regions (left rostral anterior cingulate, right frontal pole, right cuneus, and right transverse temporal) but none differed between treatment groups. Our findings suggest that minimal hippocampal volume loss occurs after stabilization on antipsychotic treatment and that citalopram's potential benefit for negative symptoms is unlikely to result from protection against hippocampal volume loss or cortical thinning.
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http://dx.doi.org/10.1016/j.pscychresns.2021.111286DOI Listing
April 2021

Association of Aripiprazole With Reduced Hippocampal Atrophy During Maintenance Treatment of First-Episode Schizophrenia.

J Clin Psychopharmacol 2021 May-Jun 01;41(3):244-249

Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai.

Purpose/background: Hippocampal volume loss in early schizophrenia has been linked with markers of inflammation and oxidative stress, and with less response of negative symptoms. Aripiprazole has been reported to preserve hippocampal volume and to reduce inflammation.

Methods/procedures: Study 1 was a 12-month multicenter randomized placebo-controlled trial of citalopram added to clinician-determined second-generation antipsychotic medication in 95 patients with first-episode schizophrenia (FES), 19 of whom received aripiprazole. We compared participants taking aripiprazole with those on other antipsychotics to determine whether those on aripiprazole had less hippocampal volume loss. We also examined peripheral biomarker data from medication-naive patients with schizophrenia receiving 8 weeks of antipsychotic treatment (n = 24) to see whether markers of inflammation and oxidative stress that previously predicted hippocampal volume differed between aripiprazole (n = 9) and other antipsychotics (study 2).

Findings/results: Aripiprazole was associated with a mean increase in hippocampal volume of 0.35% (SD, 0.80%) compared with a 0.53% decrease (SD, 1.2%) with other antipsychotics during the first year of maintenance treatment in patients with FES. This difference was significant after adjusting for age, sex, citalopram treatment, and baseline Brief Psychiatric Rating Scale score (B = 0.0079, P = 0.03). Aripiprazole was also associated with reduced concentrations of the inflammatory cytokines interleukin-8 and tumor necrosis factor (P < 0.01) during the first 8 weeks of treatment in medication-naive patients with FES.

Implications/conclusions: These results suggest that aripiprazole may protect against hippocampal atrophy via an anti-inflammatory mechanism, but these results require replication in larger, randomized trials, and the clinical relevance of hippocampal volume loss is not established.
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http://dx.doi.org/10.1097/JCP.0000000000001391DOI Listing
April 2021

For Homeless People with Serious Mental Illness, Can a State Transitional Shelter Promote Racial Equity in Housing Outcomes?

J Health Care Poor Underserved 2021 ;32(1):232-244

Objective: To examine the role of race, sex, arrest history, and psychiatric diagnoses in duration of shelter tenure and housing outcomes for patients in transitional shelters.

Methods: The authors performed a three-year retrospective chart review of Massachusetts Department of Mental Health (DMH) records for individuals residing in three DMH transitional homeless shelters from 2013 to 2015.

Results: Race was not predictive of length of stay, initial disposition, or housing status at three to five-year follow-up. Arrest history negatively predicted initial housing placement, and diagnosis of substance use disorder predicted homelessness at follow-up. There were no differences by race in arrest history or diagnosis of substance use disorder.

Conclusions: Race was not a factor in duration of shelter tenure, or in securing or maintaining housing following shelter stay. Arrest history and lifetime substance use disorder were associated with more negative outcomes following transitional shelter stay.
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http://dx.doi.org/10.1353/hpu.2021.0021DOI Listing
January 2021

D-cycloserine augmentation of cognitive behavioral therapy for delusions: A randomized clinical trial.

Schizophr Res 2020 08 23;222:145-152. Epub 2020 Jun 23.

Department of Psychiatry, NYU Langone Health, New York, NY, United States of America; Nathan Kline Institute for Psychiatric Research, Orangeburg, NY, United States of America. Electronic address:

Objective: D-cycloserine (DCS) promotes consolidation of extinction learning. This study extends earlier work by examining whether DCS can enhance cognitive behavioral therapy (CBT) for delusions.

Methods: Adults reporting moderate or greater delusions were randomly assigned to receive 50 mg of DCS or placebo prior to 10 weekly CBT sessions. The primary outcome was change in severity of delusions measured with the Psychotic Symptom Rating Scale delusion subscale (PSYRATS-D). Secondary outcomes included persistence of response at 3 and 6 month follow-up and the effects of DCS on memory consolidation and cognitive flexibility. Fifty-eight participants were randomized and 44 completed the trial.

Results: The DCS and placebo groups did not differ in change from baseline to end of CBT on PSYRATS-D, nor did DCS improve memory consolidation or cognitive flexibility compared to placebo. However, at the 3 month follow-up visit (week 24), 47% of participants who completed treatment with DCS reported a 20% or greater decrease on PSYRATS-D compared to 15% in the placebo group (p = .04). Change in distress across CBT sessions interacted with treatment group to predict change from baseline to week 24 in PSYRATS-D total score (p = .03) such that response at week 24 was greatest in DCS-treated participants who experienced a decrease in distress during CBT sessions.

Conclusions: DCS augmentation of CBT did not improve delusions compared to placebo during treatment; however, DCS was associated with a higher response rate at 3-month follow-up. DCS may produce a delayed therapeutic effect, associated with successful CBT sessions, but this finding requires replication.
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http://dx.doi.org/10.1016/j.schres.2020.06.015DOI Listing
August 2020

Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial.

JAMA Netw Open 2020 06 1;3(6):e207247. Epub 2020 Jun 1.

Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Importance: Persons with serious mental illness have a cardiovascular disease mortality rate more than twice that of the overall population. Meaningful cardiovascular risk reduction requires targeted efforts in this population, who often have psychiatric symptoms and cognitive impairment.

Objective: To determine the effectiveness of an 18-month multifaceted intervention incorporating behavioral counseling, care coordination, and care management for overall cardiovascular risk reduction in adults with serious mental illness.

Design, Setting, And Participants: This randomized clinical trial was conducted from December 2013 to November 2018 at 4 community mental health outpatient programs in Maryland. The study recruited adults with at least 1 cardiovascular disease risk factor (hypertension, diabetes, dyslipidemia, current tobacco smoking, and/or overweight or obesity) attending the mental health programs. Of 398 participants screened, 269 were randomized to intervention (132 participants) or control (137 participants). Data collection staff were blinded to group assignment. Data were analyzed on the principle of intention to treat, and data analysis was performed from November 2018 to March 2019.

Interventions: A health coach and nurse provided individually tailored cardiovascular disease risk reduction behavioral counseling, collaborated with physicians to implement appropriate risk factor management, and coordinated with mental health staff to encourage attainment of health goals. Programs offered physical activity classes and received consultation on serving healthier meals; intervention and control participants were exposed to these environmental changes.

Main Outcomes And Measures: The primary outcome was the change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), which estimates the 10-year probability of a cardiovascular disease event, from baseline to 18 months, expressed as percentage change for intervention compared with control.

Results: Of 269 participants randomized (mean [SD] age, 48.8 [11.9] years; 128 men [47.6%]), 159 (59.1%) had a diagnosis of schizophrenia or schizoaffective disorder, 67 (24.9%) had bipolar disorder, and 38 (14.1%) had major depressive disorder. At 18 months, the primary outcome, FRS, was obtained for 256 participants (95.2%). The mean (SD) baseline FRS was 11.5% (11.5%) (median, 8.6%; interquartile range, 3.9%-16.0%) in the intervention group and 12.7% (12.7%) (median, 9.1%; interquartile range, 4.0%-16.7%) in the control group. At 18 months, the mean (SD) FRS was 9.9% (10.2%) (median, 7.7%; interquartile range, 3.1%-12.0%) in the intervention group and 12.3% (12.0%) (median, 9.7%; interquartile range, 4.0%-15.9%) in the control group. Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months.

Conclusions And Relevance: An 18-month behavioral counseling, care coordination, and care management intervention statistically significantly reduced overall cardiovascular disease risk in adults with serious mental illness. This intervention provides the means to substantially reduce health disparities in this high-risk population.

Trial Registration: ClinicalTrials.gov Identifier: NCT02127671.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.7247DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7293000PMC
June 2020

Developing a Sound Body: Open Trial Results of a Group Healthy Lifestyle Intervention for Young Adults with Psychosis.

Community Ment Health J 2020 Jun 10. Epub 2020 Jun 10.

Center of Excellence for Psychosocial and Systemic Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.

The mortality disparity for persons with schizophrenia spectrum disorders (SSDs) due to cardiovascular disease is a devastating problem. Many risk factors are present in young adults with psychosis that may be ameliorated with lifestyle interventions. Sixteen participants with SSDs enrolled in an 11-week open trial of a novel lifestyle intervention comprised of group high intensity interval training exercise and health and wellness education. The aims were to evaluate (1) feasibility and (2) impact on sedentary behavior, physical activity, nutritional knowledge, physiological outcomes, and psychological well-being at end of intervention and 11-week follow-up. Attendance rates were 70% or higher for both intervention components and participants reported increased learning about healthy eating and exercise habits. Moderate to large effect sizes were observed for physical activity and sedentary behavior with sustained improvements in sedentary behavior at follow-up. Meaningful changes were not observed in other domains.
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http://dx.doi.org/10.1007/s10597-020-00655-yDOI Listing
June 2020

Efficacy and Moderators of Cognitive Behavioural Therapy for Psychosis Versus Other Psychological Interventions: An Individual-Participant Data Meta-Analysis.

Front Psychiatry 2020 5;11:402. Epub 2020 May 5.

Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit, Amsterdam, Netherlands.

Background: Study-level meta-analyses have demonstrated the efficacy of cognitive-behavioural therapy for psychosis (CBTp). Limitations of conventional meta-analysis may be addressed using individual-participant-data (IPD). We aimed to determine a) whether results from IPD were consistent with study-level meta-analyses and b) whether demographic and clinical characteristics moderate treatment outcome.

Methods: We systematically searched PubMed, Embase, PsychInfo and CENTRAL. Authors of RCTs comparing CBTp with other psychological interventions were contacted to obtain original databases. Hierarchical mixed effects models were used to examine efficacy for psychotic symptoms. Patient characteristics were investigated as moderators of symptoms at post-treatment. Sensitivity analyses were conducted for risk of bias, treatment format and study characteristics.

Results: We included 14 of 23 eligible RCTs in IPD meta-analyses including 898 patients. Ten RCTs minimised risk of bias. There was no significant difference in efficacy between RCTs providing IPD and those not (0.05). CBTp was superior vs. other interventions for total psychotic symptoms and PANSS general symptoms. No demographic or clinical characteristics were robustly demonstrated as moderators of positive, negative, general or total psychotic symptoms at post-treatment. Sensitivity analyses demonstrated that number of sessions moderated the impact of treatment assignment (CBTp or other therapies) on total psychotic symptoms ( = 0.02).

Conclusions: IPD suggest that patient characteristics, including severity of psychotic symptoms, do not significantly influence treatment outcome in psychological interventions for psychosis while investing in sufficient dosage of CBTp is important. IPD provide roughly equivalent efficacy estimates to study-level data although significant benefit was not replicated for positive symptoms. We encourage authors to ensure IPD is accessible for future research.
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http://dx.doi.org/10.3389/fpsyt.2020.00402DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214739PMC
May 2020

Rationale, Methods, Feasibility, and Preliminary Outcomes of a Transdiagnostic Prevention Program for At-Risk College Students.

Front Psychiatry 2019 25;10:1030. Epub 2020 Feb 25.

Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States.

Purpose: Early adulthood represents one period of increased risk for the emergence of a serious mental illness. The college campus provides a unique opportunity to assess and monitor individuals in this at-risk age group. However, there are no validated early detection programs that are widely implemented on college campuses. In an effort to address this gap, we designed and tested an early detection and prevention program tailored to college students. A transdiagnostic approach was employed because of evidence for shared risk factors across major mental illnesses.

Design: Single arm, prospective study evaluating outcomes following a 4-week intervention.

Method: Three in-person mental health screenings were conducted on the campus of one university. Undergraduate students with at least mildly elevated, self-reported levels of depressive or subclinical psychotic symptoms, who were not receiving treatment for these symptoms, were invited to participate in a 4-session workshop focused on increasing self- and other- awareness and emotion regulation using established mindfulness, self-compassion, and mentalization principles and experiential exercises. Symptoms, resilience-promoting capacities, and aspects of social functioning were assessed pre- and post- intervention.

Results: 416 students were screened and a total of 63 students participated in the workshop. 91% attended at least 3 of the 4 sessions. The majority of participants found the workshop interesting and useful and would recommend it to a friend. Significant pre-to-post reductions in symptoms (depression, anxiety, and subclinical psychotic symptoms, s < 0.004) and improvements in resilience-promoting capacities (self-compassion and self-efficacy, s < 0.006) and indices of social functioning (social motivation, activity, and a measure of comfort with the physical presence of others, s < 0.04) were observed. Moreover, the significant increases in resilience-promoting capacities correlated with the reductions in affective symptoms (s < 0.03).

Conclusions: These findings suggest that an on-campus mental health screening and early intervention program is feasible, acceptable, and may be associated with improvements in resilience-related capacities and symptom reductions in young adults with non-impairing, subclinical symptoms of psychopathology. Follow-up work will determine whether this program can improve both shorter and longer-term mental health and functional outcomes in this at-risk population.
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http://dx.doi.org/10.3389/fpsyt.2019.01030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7051934PMC
February 2020

Evidence-Based Psychosocial Treatment for Individuals with Early Psychosis.

Child Adolesc Psychiatr Clin N Am 2020 01 9;29(1):211-223. Epub 2019 Oct 9.

Massachusetts General Hospital, Center of Excellence in Psychosocial and Systemic Research, 151 Merrimac Street, 6th Floor, Boston, MA 02114, USA; Harvard Medical School, Boston, MA, USA.

Coordinated specialty care (CSC) first-episode models are an evidence-based practice in the treatment of first-episode psychosis. Group, individual, and family therapies in CSC aim to help the client and family understand and cope with the experience of psychosis, promote symptomatic and functional recovery and improve quality of life, and support the pursuit of personally meaningful goals of the client. Common elements to these interventions include building a therapeutic alliance, recovery orientation, education, and skills training, which can be directed to a range of targets, including problem-solving, communication, social skills, and social cognition.
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http://dx.doi.org/10.1016/j.chc.2019.08.013DOI Listing
January 2020

The Changing Legal Landscape of Cannabis Use and Its Role in Youth-onset Psychosis.

Child Adolesc Psychiatr Clin N Am 2020 01 9;29(1):145-156. Epub 2019 Oct 9.

Harvard Medical School, Boston, MA USA; Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Boston, MA 02114, USA.

The rapidly changing landscape of cannabis in terms of availability, potency, and routes of administration, as well as the decrease in risk perception and changing norms, have contributed to an increase in the popularity of cannabis. Cannabis use is associated with a poorer recovery from a psychotic disorder, increasing the risk of relapse, rehospitalization, and lower social functioning. Data are mixed regarding cannabis use as a component cause of psychosis in people at risk for psychotic disorder. Care providers, parents, and schools must educate youth and adolescents about the risks of cannabis use.
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http://dx.doi.org/10.1016/j.chc.2019.08.016DOI Listing
January 2020

Smoking cessation in people with serious mental illness.

Lancet Psychiatry 2019 07 10;6(7):563-564. Epub 2019 Apr 10.

Johns Hopkins School of Medicine and Bloomberg School for Public Health, John Hopkins University, Baltimore, MD, USA.

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http://dx.doi.org/10.1016/S2215-0366(19)30139-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7301342PMC
July 2019

Need for Cardiovascular Risk Reduction in Persons With Serious Mental Illness: Design of a Comprehensive Intervention.

Front Psychiatry 2018 8;9:786. Epub 2019 Feb 8.

Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.

Persons with serious mental illness (SMI) comprise a high-risk group for cardiovascular disease (CVD)-related mortality with rates at least twice those of the overall US. Potentially modifiable CVD risk behaviors (tobacco smoking, obesity, physical inactivity, unhealthy diet) and risk factors (hypertension, diabetes, dyslipidemia) are all markedly elevated in persons with SMI. Evaluations of programs implementing integrated medical care into specialty mental health settings have not shown meaningful effects on CVD risk factor reduction. Rigorously tested, innovative interventions are needed to address the large burden of CVD risk in populations with SMI. In this article, we describe the design of a comprehensive 18-month intervention to decrease CVD risk that we are studying in a randomized clinical trial in a community mental health organization with psychiatric rehabilitation programs. The individual-level intervention incorporated health behavior coaching and care coordination/care management to address all seven CVD risk behaviors and risk factors, and is delivered by a health coach and nurse. If successful, the intervention could be adopted within current integrated care models and significantly improve the physical health of persons with SMI.
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http://dx.doi.org/10.3389/fpsyt.2018.00786DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6375886PMC
February 2019

A placebo-controlled randomized trial of D-cycloserine augmentation of cue exposure therapy for smoking cessation.

Cogn Behav Ther 2019 01 16;48(1):65-76. Epub 2018 Aug 16.

b Department of Psychiatry and Harvard Medical School , Massachusetts General Hospital , Boston , MA , USA.

Recent studies underscore the importance of studying d-cycloserine (DCS) augmentation under conditions of adequate cue exposure treatment (CET) and protection from reconditioning experiences. In this randomized trial, we evaluated the efficacy of DCS for augmenting CET for smoking cessation under these conditions. Sixty-two smokers attained at least 18 hours abstinence following 4 weeks of smoking cessation treatment and were randomly assigned to receive a single dose of DCS (n=30) or placebo (n=32) prior to each of two sessions of CET. Mechanistic outcomes were self-reported cravings and physiologic reactivity to smoking cues. The primary clinical outcome was 6-week, biochemically-verified, continuous tobacco abstinence. DCS, relative to placebo, augmentation of CET resulted in lower self-reported craving to smoking pictorial and in vivo cues (d = 0.8 to 1.21) in a relevant subsample of participants who were reactive to cues and free from smoking-related reconditioning experiences. Select craving outcomes were correlated with smoking abstinence, and DCS augmentation was associated with a trend toward a higher continuous abstinence rate (33% vs. 13% for placebo augmentation). DCS augmentation of CET can significantly reduce cue-induced craving, supporting the therapeutic potential of DCS augmentation when applied under appropriate conditions for adequate extinction learning.
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http://dx.doi.org/10.1080/16506073.2018.1476908DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6543820PMC
January 2019

Impact of comprehensive treatment for first episode psychosis on substance use outcomes: A randomized controlled trial.

Psychiatry Res 2018 10 24;268:303-311. Epub 2018 Jul 24.

Department of Psychiatry, University of Minnesota, Minneapolis, MN USA.

Lifetime co-occurring substance use disorders are common at the time of presentation for treatment of a first episode of primary psychosis and persistent substance use disorder (SUD) leads to poorer outcomes. We assessed whether the NAVIGATE program, a coordinated specialty care service that includes optional substance abuse content reduced substance use compared to usual care in 404 individuals in the Recovery After Initial Schizophrenia Episode-Early Treatment Program (RAISE-ETP) study. Participants were randomized to two years of NAVIGATE (n = 223) or usual care (n = 181) and assessed monthly for substance use. At baseline, over one-half (51.7%) of the participants met criteria for a lifetime SUD, including over one-third with alcohol use disorder (36.4%) and with cannabis use disorder (34.7%). Contrary to our hypothesis, there was no treatment group by time interaction effect on days of self-reported substance use over the two-year follow-up. Participant exposure to the substance abuse component of the NAVIGATE program was low, suggesting that modifications to the program and training method for clinicians may be needed. Further research is needed to determine the most effective strategies for addressing substance use disorders in persons recovering from a first episode of psychosis.
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http://dx.doi.org/10.1016/j.psychres.2018.06.055DOI Listing
October 2018

Phase IIb Trial of an α7 Nicotinic Receptor Partial Agonist With and Without Nicotine Patch for Withdrawal-Associated Cognitive Deficits and Tobacco Abstinence.

J Clin Psychopharmacol 2018 Aug;38(4):307-316

Department of Biostatistics, Massachusetts General Hospital, Boston, MA.

Purpose/background: The objective of this study was to determine whether a novel α7 nicotinic acetylcholine receptor partial agonist improves cognition during nicotine withdrawal and improves abstinence rates. To do so, the effect of the α7 nicotinic acetylcholine receptor partial agonist, encenicline, on cognition and abstinence was evaluated when given as monotherapy and when combined with transdermal nicotine patch (nicotine replacement therapy [NRT]).

Methods: Adult daily smokers, n = 160, who were motivated to quit smoking completed cognitive testing at satiated baseline and after overnight abstinence and then were randomized to receive a 12-week trial of encenicline 1 mg twice daily or identical placebo the day of the overnight abstinent cognitive testing. In the first 6 weeks of the 12-week encenicline administration, participants were also randomized to 6 weeks of NRT patch or placebo patch. Primary outcomes were cognition during abstinence and 7-day point-prevalence abstinence at week 12.

Results: No beneficial effects of encenicline were observed on cognition or abstinence when compared with placebo or when combined with NRT compared with placebo capsule + NRT. Of the 4 conditions, abstinence rates were lowest among those assigned to encenicline alone.

Conclusions: Beneficial effects of NRT were observed on cognitive and abstinence outcomes when combined with encenicline compared with encenicline plus placebo patch. Addition of NRT to encenicline improved odds of abstinence approximately 3-fold compared with encenicline plus placebo patch. We conclude that encenicline, 1 mg/d, did not improve abstinence-associated cognitive impairment or abstinence rates as monotherapy or adjunctive therapy to NRT patch.
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http://dx.doi.org/10.1097/JCP.0000000000000919DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6019566PMC
August 2018

Achieving Smoking Cessation in Individuals with Schizophrenia: Special Considerations.

CNS Drugs 2017 Jun;31(6):471-481

Department of Psychiatry, Center for Addiction Medicine, Massachusetts General Hospital, 60 Staniford Street, Boston, MA, 02114, USA.

Premature mortality due to cardiovascular disease in those with schizophrenia is the largest lifespan disparity in the US and is growing; adults in the US with schizophrenia die, on average, 28 years earlier than those in the general population. The rate of smoking prevalence among individuals with schizophrenia is estimated to be from 64 to 79%. Smokers with schizophrenia have historically been excluded from most large nicotine-dependence treatment studies. However, converging evidence indicates that a majority of smokers with schizophrenia want to quit smoking, and that available pharmacotherapeutic smoking cessation aids are well tolerated by this population of smokers and are effective when combined with behavioral treatment. The aim of this review is to present updated evidence for safety and efficacy of smoking cessation interventions for those with schizophrenia spectrum illness. We also highlight implications of the very low abstinence rates for smokers with schizophrenia who receive placebo plus behavioral treatment in randomized trials, and review treatment approaches to address the high rate of rapid relapse observed upon pharmacologic treatment discontinuation in this population. Recommendations for monitoring for treatment-emergent nicotine withdrawal symptoms, side effects, and effects of cessation on antipsychotic medication are also provided. Smokers with schizophrenia spectrum disorders should be encouraged to quit smoking and should receive varenicline, bupropion with or without nicotine replacement therapy (NRT), or NRT, all in combination with behavioral treatment for at least 12 weeks. Maintenance pharmacotherapy may reduce relapse and improve sustained abstinence rates. Controlled trials in smokers with schizophrenia consistently show no greater rate of neuropsychiatric adverse events with pharmacotherapeutic cessation aids than with placebo.
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http://dx.doi.org/10.1007/s40263-017-0438-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5646360PMC
June 2017

Achieving Smoking Cessation in Individuals with Schizophrenia: Special Considerations.

CNS Drugs 2017 Jun;31(6):471-481

Department of Psychiatry, Center for Addiction Medicine, Massachusetts General Hospital, 60 Staniford Street, Boston, MA, 02114, USA.

Premature mortality due to cardiovascular disease in those with schizophrenia is the largest lifespan disparity in the US and is growing; adults in the US with schizophrenia die, on average, 28 years earlier than those in the general population. The rate of smoking prevalence among individuals with schizophrenia is estimated to be from 64 to 79%. Smokers with schizophrenia have historically been excluded from most large nicotine-dependence treatment studies. However, converging evidence indicates that a majority of smokers with schizophrenia want to quit smoking, and that available pharmacotherapeutic smoking cessation aids are well tolerated by this population of smokers and are effective when combined with behavioral treatment. The aim of this review is to present updated evidence for safety and efficacy of smoking cessation interventions for those with schizophrenia spectrum illness. We also highlight implications of the very low abstinence rates for smokers with schizophrenia who receive placebo plus behavioral treatment in randomized trials, and review treatment approaches to address the high rate of rapid relapse observed upon pharmacologic treatment discontinuation in this population. Recommendations for monitoring for treatment-emergent nicotine withdrawal symptoms, side effects, and effects of cessation on antipsychotic medication are also provided. Smokers with schizophrenia spectrum disorders should be encouraged to quit smoking and should receive varenicline, bupropion with or without nicotine replacement therapy (NRT), or NRT, all in combination with behavioral treatment for at least 12 weeks. Maintenance pharmacotherapy may reduce relapse and improve sustained abstinence rates. Controlled trials in smokers with schizophrenia consistently show no greater rate of neuropsychiatric adverse events with pharmacotherapeutic cessation aids than with placebo.
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http://dx.doi.org/10.1007/s40263-017-0438-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5646360PMC
June 2017

Predictors of tobacco abstinence in outpatient smokers with schizophrenia or bipolar disorder treated with varenicline and cognitive behavioral smoking cessation therapy.

Addict Behav 2017 08 24;71:89-95. Epub 2017 Feb 24.

Center for Addiction Medicine, Department of Psychiatry, Massachusetts General Hospital, United States; Harvard Medical School, United States.

Background: The estimated mortality gap between those with and without serious mental illness (SMI) is increasing, now estimated at 28years, which is largely due to smoking-related diseases.

Aims: We sought to identify predictors of 14-day continuous abstinence in stable outpatient smokers with SMI.

Method: Adult smokers with schizophrenia spectrum (n=130) or bipolar disorder (n=23) were enrolled in a 12-week course of varenicline and cognitive-behavioral therapy for smoking cessation.

Results: Independent predictors of abstinence included reduction in withdrawal symptoms prior to the quit day, fewer cigarettes smoked per day at baseline, better baseline attention, remitted alcohol dependence, and lower expectation of peer support to aid quitting.

Conclusions: Interventions that consider these targets may improve smoking cessation outcomes in those with SMI.
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http://dx.doi.org/10.1016/j.addbeh.2017.02.028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6499932PMC
August 2017

A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol.

BMC Public Health 2017 01 19;17(1):100. Epub 2017 Jan 19.

Center for Addiction Medicine, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.

Background: The U.S. Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. This study evaluates the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders using a two-site, two-arm, double-blind, parallel group, randomized controlled trial (RCT) in four phases over 34 weeks.

Methods: Adult smokers (N = 200) of 5 or more cigarettes per day will be randomized across two sites (Penn State and Massachusetts General). Participants must have not had a quit attempt in the prior month, nor be planning to quit in the next 6 months, meet criteria for a current or lifetime unipolar mood and/or anxiety disorder based on the structured Mini-International Neuropsychiatric Interview, and must not have an unstable medical or psychiatric condition. After a week of smoking their own cigarettes, participants receive two weeks of Spectrum research cigarettes with usual nicotine content (11.6 mg). After this baseline period, participants will be randomly assigned to continue smoking Spectrum research cigarettes that contain either (a) Usual Nicotine Content (11.6 mg); or (b) Reduced Nicotine Content: the nicotine content per cigarette is progressively reduced from approximately 11.6 mg to 0.2 mg in five steps over 18 weeks. At the end of the randomization phase, participants will be offered the choice to either (a) quit smoking with assistance, (b) continue smoking free research cigarettes, or (c) return to purchasing their own cigarettes, for the final 12 weeks of the study. The primary outcome measure is blood cotinine; key secondary outcomes are: exhaled carbon monoxide, urinary total NNAL- 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and 1-hydroxypyrene, oxidative stress biomarkers including 8-isoprostanes, measures of psychiatric symptoms (e.g., depression, anxiety), smoking behavior and dependence (e.g., cigarette consumption, quit attempts), and health effects (e.g., blood pressure, respiratory symptoms).

Discussion: Results from this study will inform FDA on the potential effects of regulating the nicotine content of cigarettes and help determine whether smokers with mood and/or anxiety disorders can safely transition to significantly reduced nicotine content cigarettes.

Trial Registration: TRN: NCT01928758 , registered August 21, 2013.
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http://dx.doi.org/10.1186/s12889-016-3946-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5248523PMC
January 2017

Maintenance pharmacotherapy normalizes the relapse curve in recently abstinent tobacco smokers with schizophrenia and bipolar disorder.

Schizophr Res 2017 05 9;183:124-129. Epub 2016 Dec 9.

Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States.

Objective: To compare the effect of maintenance pharmacotherapy on sustained abstinence rates between recently abstinent smokers with schizophrenia and bipolar disorder (SBD) and general population smokers without psychiatric illness.

Method: We performed a person-level, pooled analysis of two randomized controlled trials of maintenance varenicline, conducted in adult smokers with SBD and general population smokers, controlling for severity of dependence. Smokers abstinent after 12-weeks of open varenicline treatment were randomly assigned to ≥12-weeks maintenance varenicline or identical placebo.

Results: In those assigned to maintenance placebo, the abstinence rate at week-24 was lower in those with SBD than for those without psychiatric illness (29.4±1.1% vs. 61.8±0.4%, OR:0.26, 95% CI: 0.13, 0.52, p<0.001). In smokers assigned to maintenance pharmacotherapy, however, there was no effect of diagnosis on abstinence rates at week-24 (87.2±0.8% vs. 81.9±0.2%, OR: 1.68, 95% CI: 0.53, 5.32, p=0.38). Time to first lapse was shortest in those with SBD assigned to maintenance placebo (Q1=12days, 95%CI: 4, 16), longer in those without psychiatric illness assigned to maintenance placebo (Q1=17days, 95%CI: 17, 29), still longer in general-population smokers assigned to maintenance varenicline (Q1=88, 95% CI:58,91, and longest in those with SBD who received maintenance varenicline (Q1>95days, 95%CI:non-est), (Χ=96.99, p<0.0001; all pairwise comparisons p<0.001).

Conclusions: Following a standard 12-week course of pharmacotherapy, people with schizophrenia and bipolar disorder were more likely to relapse to smoking without maintenance varenicline treatment. Maintenance pharmacotherapy could improve longer-term tobacco abstinence rates and reduce known smoking-related health disparities in those with SMI.
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http://dx.doi.org/10.1016/j.schres.2016.11.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5432398PMC
May 2017

Weight gain and 10-year cardiovascular risk with sustained tobacco abstinence in smokers with serious mental illness: a subgroup analysis of a randomized trial.

J Clin Psychiatry 2016 Mar;77(3):e320-6

Massachusetts General Hospital, 50 Staniford St, 9th Fl, Boston, MA 02114

Objective: People with serious mental illness die earlier than those without mental illness, largely from cardiovascular disease due to high rates of smoking and obesity. The objective of this study was to determine whether the metabolic effects of postcessation weight gain among smokers with serious mental illness attenuated the cardiovascular benefit of tobacco abstinence.

Method: A subgroup analysis was conducted of 65 outpatient smokers with DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder from 10 community mental health centers in 6 states who enrolled between March 2008-April 2012 and completed a trial of varenicline for tobacco abstinence. The intervention included a 12-week open-label phase with varenicline followed by a 40-week randomized, placebo-controlled phase in 87 participants who achieved 12-week abstinence. Main outcome measures were smoking status and change from baseline in weight and 10-year Framingham cardiovascular risk score at end of intervention (week 52).

Results: At week 52, 65 participants completed follow-up (33 abstinent; 32 relapsed). At baseline, the 2 groups did not differ in body mass index (mean = 31 kg/m(2)), blood pressure, serum glucose, or diagnoses of diabetes (31%) and hypertension (34%). Abstinent participants were older and had a higher mean baseline Framingham risk score (14.2% vs 10.3%, P = .002). At week 52, abstinent participants gained more weight than relapsed participants (4.8 vs 1.2 kg, P = .048) and, as a result of quitting smoking, had a greater reduction in Framingham risk score (-7.6% vs 0.0%, P < .001). There was no effect of study drug assignment on weight or Framingham risk score.

Conclusions: Sustained tobacco abstinence reduced 10-year cardiovascular risk in outpatients with serious mental illness despite significant postcessation weight gain and high prevalence of obesity, diabetes, and hypertension.

Trial Registration: Clinicaltrials.gov identifier: NCT00621777.
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http://dx.doi.org/10.4088/JCP.15m10074DOI Listing
March 2016

Effective Cessation Strategies for Smokers with Schizophrenia.

Int Rev Neurobiol 2015 14;124:133-47. Epub 2015 Sep 14.

Center for Addiction Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.

Despite availability of smoking cessation aids with proven efficacy and tolerability in those with schizophrenia, addiction to tobacco-derived nicotine remains highly prevalent among those with schizophrenia spectrum disorders. While smokers with serious mental illness have been excluded from most large nicotine-dependence treatment studies, and these treatments are woefully underutilized for smokers with psychiatric illness, a growing evidence base is available to guide cessation treatment for smokers with schizophrenia. The aim of this review is to present the evidence on safety and efficacy of smoking cessation interventions for those with schizophrenia spectrum illness. Smokers with schizophrenia spectrum disorders should receive varenicline or bupropion with or without nicotine replacement therapy in combination with behavioral treatment. Clinical practice guidelines now recommend duration of treatment be 12 weeks, but evidence indicates that maintenance pharmacotherapy for 1 year improves sustained abstinence rates. Controlled trials have found no evidence that in patients with serious mental illness, the use of pharmacotherapeutic cessation aids worsens psychiatric symptoms or increases the rate of psychiatric adverse events. Converging evidence indicates that a majority of smokers with serious mental illness want to quit smoking and that available pharmacotherapeutic cessation aids combined with behavioral support are both effective for, and well tolerated by, these smokers.
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http://dx.doi.org/10.1016/bs.irn.2015.08.001DOI Listing
July 2016

The NAVIGATE Program for First-Episode Psychosis: Rationale, Overview, and Description of Psychosocial Components.

Psychiatr Serv 2015 Jul 16;66(7):680-90. Epub 2015 Mar 16.

Dr. Mueser, Dr. Gottlieb, and Dr. McGurk are with the Center for Psychiatric Rehabilitation and the Department of Occupational Therapy, Sargent College, Boston University, Boston (e-mail: ). Dr. Penn and Dr. Saade are with the Department of Psychology, University of North Carolina, Chapel Hill. Dr. Penn is also with the School of Psychology, Australian Catholic University, Melbourne. Dr. Addington is with the Department of Psychiatry, University of Calgary, Calgary, Alberta, Canada. Dr. Brunette is with the Department of Psychiatry, Geisel School of Medicine, Lebanon, New Hampshire. Ms. Gingerich is an independent consultant and trainer in Narberth, Pennsylvania. Dr. Glynn is with the Mental Illness Research, Education and Clinical Center (MIRECC), Department of Veterans Affairs (VA) Greater Los Angeles Healthcare System, Los Angeles. Mr. Lynde is an independent consultant and trainer in Concord, New Hampshire. Dr. Meyer-Kalos is with the Department of Social Work, Minnesota Center for Chemical and Mental Health, St. Paul. Dr. Cather is with the Department of Psychiatry, Massachusetts General Hospital, Boston. Dr. Robinson and Dr. Kane are with the Department of Psychiatry Research, Zucker Hillside Hospital, Glen Oaks, New York. Dr. Schooler is with the Department of Psychiatry and Behavioral Sciences, SUNY Downstate Medical Center, Brooklyn, New York. Dr. Rosenheck is with the Department of Psychiatry, Yale Medical School, New Haven, Connecticut, and with the MIRECC, VA New England Healthcare System, West Haven, Connecticut. This article is part of a special section on RAISE and other early intervention services. Marcela Horvitz-Lennon, M.D., M.P.H., served as guest editor of the special section.

Comprehensive coordinated specialty care programs for first-episode psychosis have been widely implemented in other countries but not in the United States. The National Institute of Mental Health's Recovery After an Initial Schizophrenia Episode (RAISE) initiative focused on the development and evaluation of first-episode treatment programs designed for the U.S. health care system. This article describes the background, rationale, and nature of the intervention developed by the RAISE Early Treatment Program project-known as the NAVIGATE program-with a particular focus on its psychosocial components. NAVIGATE is a team-based, multicomponent treatment program designed to be implemented in routine mental health treatment settings and aimed at guiding people with a first episode of psychosis (and their families) toward psychological and functional health. The core services provided in the NAVIGATE program include the family education program (FEP), individual resiliency training (IRT), supported employment and education (SEE), and individualized medication treatment. NAVIGATE embraces a shared decision-making approach with a focus on strengths and resiliency and on collaboration with clients and family members in treatment planning and reviews. The NAVIGATE program has the potential to fill an important gap in the U.S. health care system by providing a comprehensive intervention specially designed to meet the unique treatment needs of persons recovering from a first episode of psychosis. A cluster-randomized controlled trial comparing NAVIGATE with usual community care has recently been completed.
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http://dx.doi.org/10.1176/appi.ps.201400413DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4490051PMC
July 2015

Treatment of tobacco use disorders in smokers with serious mental illness: toward clinical best practices.

Harv Rev Psychiatry 2015 Mar-Apr;23(2):90-8

From Harvard Medical School (Drs. Evins and Cather); Center for Addiction Medicine, Department of Psychiatry, Massachusetts General Hospital (Drs. Evins and Cather, and Ms. Laffer).

Addiction to tobacco-derived nicotine remains highly prevalent in the United States, with 18% using daily, and 53% of those with serious mental illness using daily. While smokers with serious mental illness have been excluded from most large nicotine-dependence treatment studies, a growing evidence base is available to guide clinicians in assisting their patients with psychiatric illness to quit smoking. The aim of this review is to present the evidence on safety and efficacy of smoking cessation interventions for those with serious mental illness. Smokers with schizophrenia spectrum disorders should receive varenicline or bupropion with or without nicotine replacement therapy in combination with behavioral treatment. Although more research is needed, preliminary evidence suggests that varenicline in combination with behavioral support is efficacious and well tolerated for smoking cessation for those with bipolar disorder and major depressive disorder. Controlled trials have found no evidence that in patients with serious mental illness, the use of pharmacotherapeutic cessation aids worsens psychiatric symptoms or increases the rate of psychiatric adverse events. Converging evidence indicates that a majority of smokers with serious mental illness want to quit smoking and that available pharmacotherapeutic cessation aids combined with behavioral support are both effective for, and well tolerated by, these smokers.
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http://dx.doi.org/10.1097/HRP.0000000000000063DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4460830PMC
December 2015

A randomized placebo-controlled pilot study of pravastatin as an adjunctive therapy in schizophrenia patients: effect on inflammation, psychopathology, cognition and lipid metabolism.

Schizophr Res 2014 Nov 26;159(2-3):395-403. Epub 2014 Sep 26.

Schizophrenia Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, 25 Staniford Street, Boston, MA 02114, United States. Electronic address:

Objective: The aim of this study was to investigate the role of pravastatin, as an adjunctive therapy, on inflammatory markers, lipid and glucose metabolism, psychopathology, and cognition in subjects with schizophrenia and schizoaffective disorder.

Methods: Schizophrenia or schizoaffective subjects (N=60) were randomized to receive either a 12-week supply of pravastatin 40 mg/day or placebo treatment. Anthropometric measures, lipids and glucose metabolism, inflammatory markers, psychopathology and cognitive performance were assessed at baseline, 6 weeks and 12 weeks.

Results: Pravastatin use was associated with a significant decrease in total cholesterol, low density lipoprotein (LDL) cholesterol and LDL particle number levels, but was not associated with any significant changes in cognition or psychopathology in the participants, except a significant decrease in the Positive and Negative Syndrome Scale (PANSS) positive symptom score from baseline to week 6. However, this decrease failed to remain significant at 12 weeks. Interestingly, triglycerides, LDL-cholesterol, total cholesterol, LDL particle number, small LDL particle number, large very low density lipoprotein (VLDL) particle number and C-reactive protein (CRP) followed a similar pattern at 6 and 12 weeks as psychopathology.

Conclusions: These results suggest that a randomized trial with a larger sample size and a higher dosage of pravastatin would be helpful in further evaluating the anti-inflammatory properties of pravastatin, its association with improvements in cognitive symptoms, and its potential to reduce positive and negative symptoms associated with schizophrenia or schizoaffective disorders.
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http://dx.doi.org/10.1016/j.schres.2014.08.021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4311769PMC
November 2014

Evolving illness, shifting perspectives: childhood psychosis through the lenses of family therapy and individual therapy.

Harv Rev Psychiatry 2013 Sep-Oct;21(5):259-68

From Harvard Medical School; Department of Psychiatry, Massachusetts General Hospital, Boston, MA (Drs. Greene, Spencer, Cather, and Ablon); McLean Hospital, Belmont, MA (Dr. Pridgen).

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http://dx.doi.org/10.1097/HRP.0b013e3182a75c7aDOI Listing
December 2014

Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder: a randomized clinical trial.

JAMA 2014 Jan;311(2):145-54

Massachusetts General Hospital and Harvard Medical School, Boston.

Importance: It is estimated that more than half of those with serious mental illness smoke tobacco regularly. Standard courses of pharmacotherapeutic cessation aids improve short-term abstinence, but most who attain abstinence relapse rapidly after discontinuation of pharmacotherapy.

Objective: To determine whether smokers diagnosed with schizophrenia and bipolar disease have higher rates of prolonged tobacco abstinence with maintenance pharmacotherapy than with standard treatment.

Design, Setting, And Participants: Randomized, double-blind, placebo-controlled, parallel-group, relapse-prevention clinical trial conducted in 10 community mental-health centers. Of 247 smokers with schizophrenia or bipolar disease recruited from March 2008-April 2012, 203 received 12-weeks' open-label varenicline and cognitive behavioral therapy and 87 met abstinence criteria to enter the relapse prevention intervention.

Interventions: Participants who had 2 weeks or more of continuous abstinence at week 12 of open treatment were randomly assigned to receive cognitive behavioral therapy and double-blind varenicline (1 mg, 2 per day) or placebo from weeks 12 to 52. Participants then discontinued study treatment and were followed up to week 76.

Main Outcomes And Measures: Seven-day rate of continuous abstinence at study week 52, the end of the relapse-prevention phase, confirmed by exhaled carbon monoxide. Secondary outcomes were continuous abstinence rates for weeks 12 through 64 based on biochemically verified abstinence and weeks 12 through 76, based on self-reported smoking behavior.

Results: Sixty-one participants completed the relapse-prevention phase; 26 discontinued participation (7 varenicline, 19 placebo) and were considered to have relapsed for the analyses; 18 of these had relapsed prior to dropout. At week 52, point-prevalence abstinence rates were 60% in the varenicline group (24 of 40) vs 19% (9 of 47) in the placebo group (odds ratio [OR], 6.2; 95% CI, 2.2-19.2; P < .001). From weeks 12 through 64, 45% (18 of 40) among those in the varenicline group vs 15% (7 of 47) in the placebo group were continuously abstinent (OR, 4.6; 95% CI, 1.5-15.7; P = .004), and from weeks 12 through 76, 30% (12 of 40) in the varenicline group vs 11% (5 of 47) in the placebo group were continuously abstinent (OR, 3.4; 95% CI, 1.02-13.6; P = .03). There were no significant treatment effects on psychiatric symptom ratings or psychiatric adverse events.

Conclusions And Relevance: Among smokers with serious mental illness who attained initial abstinence with standard treatment, maintenance pharmacotherapy with varenicline and cognitive behavioral therapy improved prolonged tobacco abstinence rates compared with cognitive behavioral therapy alone after 1 year of treatment and at 6 months after treatment discontinuation.

Trial Registration: clinicaltrials.gov Identifier: NCT00621777.
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http://dx.doi.org/10.1001/jama.2013.285113DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4124884PMC
January 2014

Long-term outcomes of a randomized trial of integrated skills training and preventive healthcare for older adults with serious mental illness.

Am J Geriatr Psychiatry 2014 Nov 14;22(11):1251-61. Epub 2013 Aug 14.

Massachusetts Mental Health Center, Boston, MA.

Objective: This report describes 1-, 2-, and 3-year outcomes of a combined psychosocial skills training and preventive healthcare intervention (Helping Older People Experience Success [HOPES]) for older persons with serious mental illness.

Methods: A randomized controlled trial compared HOPES with treatment as usual (TAU) for 183 older adults (age ≥ 50 years [mean age: 60.2]) with serious mental illness (28% schizophrenia, 28% schizoaffective disorder, 20% bipolar disorder, 24% major depression) from two community mental health centers in Boston, Massachusetts, and one in Nashua, New Hampshire. HOPES comprised 12 months of weekly skills training classes, twice-monthly community practice trips, and monthly nurse preventive healthcare visits, followed by a 1-year maintenance phase of monthly sessions. Blinded evaluations of functioning, symptoms, and service use were conducted at baseline and at a 1-year (end of the intensive phase), 2-year (end of the maintenance phase), and 3-year (12 months after the intervention) follow-up.

Results: HOPES compared with TAU was associated with improved community living skills and functioning, greater self-efficacy, lower overall psychiatric and negative symptoms, greater acquisition of preventive healthcare (more frequent eye exams, visual acuity, hearing tests, mammograms, and Pap smears), and nearly twice the rate of completed advance directives. No differences were found for medical severity, number of medical conditions, subjective health status, or acute service use at the 3-year follow-up.

Conclusion: Skills training and nurse facilitated preventive healthcare for older adults with serious mental illness was associated with sustained long-term improvement in functioning, symptoms, self-efficacy, preventive healthcare screening, and advance care planning.
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http://dx.doi.org/10.1016/j.jagp.2013.04.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3836872PMC
November 2014