Dataset Information

Combined Oxytocin and Cognitive Behavioral Social Skills Training for Social Function in People With Schizophrenia.

ABSTRACT:

Background

A significant proportion of people with schizophrenia are characterized by impaired ability to socially engage with others. The development of effective interventions for social functioning remains a central therapeutic challenge. Cognitive-behavioral social skills training (CBSST) has been found to improve social functioning in schizophrenia, but with only medium effect sizes. Intranasal oxytocin also has prosocial effects, but also only with modest effect sizes. This study assessed whether the addition of intranasal oxytocin to CBSST can strengthen their impact on social function.

Methods

Participants (N = 62) with schizophrenia or schizoaffective disorder entered a 24-week, double-blind, placebo-controlled, randomized clinical trial with a 3-month follow-up evaluation at 2 sites: Maryland and San Diego. Participants were randomized to either intranasal oxytocin 36 IU (3 sprays) twice a day (n = 31) or intranasal placebo-oxytocin (3 sprays) twice a day (n = 31). All participants received CBSST plus a social cognition skills training module (48 total sessions).

Results

There were no significant treatment group differences in social functioning, positive symptoms, negative symptoms, defeatist beliefs, or asocial beliefs. The interpretation of treatment effects was complicated by site effects, whereby participants in San Diego began the trial with greater severity of impairments and subsequently showed greater improvements compared with participants in Maryland.

Conclusions

The results did not support the utility of add-on intranasal oxytocin to psychosocial rehabilitation interventions like CBSST for improvement in social function (ClinicalTrials.gov trial number: NCT01752712).

SUBMITTER: Buchanan RW

PROVIDER: S-EPMC8887701 | biostudies-literature | 2021 May-Jun 01

REPOSITORIES: biostudies-literature

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Publications

Combined Oxytocin and Cognitive Behavioral Social Skills Training for Social Function in People With Schizophrenia.

Buchanan Robert W RW Kelly Deanna L DL Strauss Gregory P GP Gold James M JM Weiner Elaine E Zaranski Jennifer J Chen Shuo S Blatt Frank F Holden Jason J Granholm Eric E

Journal of clinical psychopharmacology 20210501 3

<h4>Background</h4>A significant proportion of people with schizophrenia are characterized by impaired ability to socially engage with others. The development of effective interventions for social functioning remains a central therapeutic challenge. Cognitive-behavioral social skills training (CBSST) has been found to improve social functioning in schizophrenia, but with only medium effect sizes. Intranasal oxytocin also has prosocial effects, but also only with modest effect sizes. This study a ...[more]

PMID: 33783399

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Project description:Abstract Background: A significant proportion of people with schizophrenia are characterized by impaired ability to socially engage with others, which may reflect social aversion secondary to defeatist beliefs; decreased motivation for social interactions; and/or impairment in the normal reinforcement value of social interactions. Unfortunately, pharmacological interventions have limited benefits for impaired social function, whereas psychosocial interventions provide only partial benefit for this critical aspect of the illness. The development of an effective intervention for functional outcomes remains a central therapeutic challenge. The current study assessed whether the addition of intranasal oxytocin to Cognitive Behavioral Social Skills Training (CBSST) improved social function. Methods: Participants with DSM-IV-TR schizophrenia or schizoaffective disorder entered a 24-week, double-blind, placebo-controlled, randomized clinical trial with a 3-month follow-up evaluation. The study was conducted at two sites: Maryland and California. Participants were randomized to either: intranasal oxytocin 36 I.U. (3 sprays) BID (n = 31) or intranasal placebo-oxytocin 3 sprays BID (n = 31). All participants received CBSST, which was delivered in four 6-session modules (cognitive, social, and problem-solving CBSST modules plus a module adapted from Social Cognition and Interaction Training). The modules were delivered twice in biweekly 1-hour sessions, for a total of 48 sessions over 24 weeks. Birchwood Social Functioning Scale (SFS) was used to assess social function; the Defeatist Performance Attitude Scale (DPAS) was used to assess defeatist beliefs; the Asocial Beliefs Scale (ABS) was used to assess social disinterest and aversion; and the Scale for the Assessment of Negative Symptoms (SANS) total score was used to assess negative symptoms. Results: In the intent-to-treat analyses, there were no significant group differences in the SFS total score (Treatment × Week interaction: F = 0.96; df = 2, 40; P = .39) or ABS total score (Treatment × Week interaction: F = .12; df = 2, 39.7; P = .89). There was a trend for a significant reduction in defeatist beliefs among the participants randomized to oxytocin (Treatment × Week interaction: F = 2.86; df = 2, 67.2; P = .07). There were no significant group differences in SANS total score (Treatment × Week interaction: F = 0.96; df = 6, 39.7; P = 0.46), though the interpretation of the effect of oxytocin on SANS total score was complicated by the presence of a significant site effect: there was a significant placebo effect at the California site, which was markedly greater in magnitude than the observed oxytocin effect for these symptoms. Conclusion: The results of the intent-to-treat analyses provide minimal support for the utility of add-on intranasal oxytocin to CBSST for improvement in social function. Oxytocin was associated with trend improvement in defeatist attitudes and greater reduction in negative symptoms at one of the two study sites. (clinicaltrials.gov, trial number: NCT01752712)

Project description:BackgroundSchizophrenia leads to profound disability in everyday functioning (e.g., difficulty finding and maintaining employment, housing, and personal relationships). Medications can effectively reduce positive symptoms (e.g., hallucinations and delusions), but they do not meaningfully improve daily life functioning. Psychosocial evidence-based practices (EBPs) improve functioning, but these EBPs are not available to most people with schizophrenia. The field must close the research and service delivery gap by adapting EBPs for schizophrenia to facilitate widespread implementation in community settings. Our hybrid effectiveness and implementation study represents an initiative to bridge this divide. In this study we will test whether an existing EBP (i.e., Cognitive Behavioral Social Skills Training (CBSST)) modified to work in practice settings (i.e., Assertive Community Treatment (ACT) teams) commonly available to persons with schizophrenia results in better consumer outcomes. We will also identify key factors relevant to developing future CBSST implementation strategies.Methods/designFor the effectiveness study component, persons with schizophrenia will be recruited from existing publicly funded ACT teams operating in community settings. Participants will be randomized to one of the 2 treatments (ACT alone or ACT + Adapted CBSST) and followed longitudinally for 18 months with assessments every 18 weeks after baseline (5 in total). The primary outcome domain is psychosocial functioning (e.g., everyday living skills and activities related to employment, education, and housing) as measured by self-report, testing, and observation. Additional outcome domains of interest include mediators of change in functioning, symptoms, and quality of services. Primary analyses will be conducted using linear mixed-effects models for continuous data. The implementation study component consists of a structured, mixed qualitative-quantitative methodology (i.e., Concept Mapping) to characterize and assess the implementation experience from multiple stakeholder perspectives in order to inform future implementation initiatives.DiscussionAdapting CBSST to fit into the ACT service delivery context found throughout the United States creates an opportunity to substantially increase the number of persons with schizophrenia who could have access to and benefit from EBPs. As part of the implementation learning process training materials and treatment workbooks have been revised to promote easier use of CBSST in the context of brief community-based ACT visits.Trial registrationClinicalTrials.gov NCT02254733 . Date of registration: 25 April 2014.

Project description:ObjectivesTo determine whether Cognitive Behavioral Social Skills Training (CBSST) is an effective psychosocial intervention to improve functioning in older consumers with schizophrenia, and whether defeatist performance attitudes are associated with change in functioning in CBSST.DesignAn 18-month, single-blind, randomized controlled trial.SettingOutpatient clinic at a university-affiliated Veterans Affairs hospital.ParticipantsVeteran and non-veteran consumers with schizophrenia or schizoaffective disorder (N = 79) age 45-78.InterventionsCBSST was a 36-session, weekly group therapy that combined cognitive behavior therapy with social skills training and problem-solving training to improve functioning. The comparison intervention, goal-focused supportive contact (GFSC), was supportive group therapy focused on achieving functioning goals.MeasurementsBlind raters assessed functioning (primary outcome: Independent Living Skills Survey), CBSST skill mastery, positive and negative symptoms, depression, anxiety, defeatist attitudes, self-esteem, and life satisfaction.ResultsFunctioning trajectories over time were significantly more positive in CBSST than in GFSC, especially for participants with more severe defeatist performance attitudes. Greater improvement in defeatist attitudes was also associated with better functioning in CBSST, but not GFSC. Both treatments showed comparable significant improvements in amotivation, depression, anxiety, positive self-esteem, and life satisfaction.ConclusionsCBSST is an effective treatment to improve functioning in older consumers with schizophrenia, and both CBSST and other supportive goal-focused interventions can reduce symptom distress, increase motivation and self-esteem, and improve life satisfaction. Participants with more severe defeatist performance attitudes may benefit most from cognitive behavioral interventions that target functioning.Trial registryClinicalTrials.Gov #NCT00237796 (http://clinicaltrials. gov/show/NCT00237796).

Project description:BackgroundSchizophrenia and related disorders are highly disabling and create substantial burdens for families, communities, and health care systems. Although pharmacological treatments can often lessen the psychotic symptoms that are a hallmark of schizophrenia, they do not lessen the social and cognitive deficits that create the greatest impediments to community engagement and functional recovery. This study builds on prior research on psychosocial rehabilitation by comparing the effectiveness of two treatments demonstrated as efficacious in improving social and community functioning, Cognitive Enhancement Therapy (CET) and a version of Social Skills Training (HOPES/SST).MethodsThe study uses a randomized cluster design in which a pair of clinicians at community- and hospital-based mental service centers deliver either CET or HOPES to at least one group of 6-8 eligible clients for 12 months. Clinicians are trained and then supervised weekly, with ongoing process measurement of treatment fidelity, attendance, satisfaction, and retention, and use of other services. Measures administered at baseline and at 6 and 12 months while in treatment, and then at 18 and 24 months after treatment include social adjustment, quality of life, social skills, positive and negative symptoms, and neuro- and social cognition. We hypothesize that CET will be associated with greater improvements than SST in both the primary outcome of community functioning and the secondary outcomes of neuro- and social cognition and social skills. Secondarily, we hypothesize that more cognitive impairment at baseline and younger age will predict more benefit from CET compared to HOPES.DiscussionResource shortages endemic in mental health services and exacerbated by the pandemic highlight the importance of identifying the most effective approach to improving social and community functioning. We aim to improve understanding of the impact of two efficacious psychosocial treatments and to improve clinicians' ability to refer to both treatments the individuals who are most likely to benefit from them. We expect the result to be programmatic improvements that improve the magnitude and durability of gains in community functioning.Trial registrationClinicalTrial.gov NCT04321759 , registered March 25, 2020.

Dataset Information

Combined Oxytocin and Cognitive Behavioral Social Skills Training for Social Function in People With Schizophrenia.

Background

Methods

Results

Conclusions

Publications

Combined Oxytocin and Cognitive Behavioral Social Skills Training for Social Function in People With Schizophrenia.

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