Executive Function and CBT Skills Training for Schizophrenia
(E-CBSST Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Diego
Must be taking: Antipsychotics
Disqualifiers: Cognitive disorder, Bipolar, others
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?The purpose of this research study to test a blended intervention that combines Executive Function Training with Cognitive-Behavioral Skills Training (E-CBSST). The aims include determining whether E-CBSST is feasible and increases Cognitive Behavioral Social Skills Training (CBSST) Skills Learning to a level that will lead to a clinically meaningful improvement in functioning.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that your antipsychotic medication dosage has not changed in the four weeks before starting the study.
What data supports the effectiveness of the treatment E-CBSST for schizophrenia?
Research shows that Cognitive Behavioral Social Skills Training (CBSST), a component of E-CBSST, improves functioning in people with schizophrenia compared to standard care alone. Additionally, CBSST has been found to enhance social function, especially in patients with more severe executive dysfunction, indicating its potential benefit in improving life skills for those with schizophrenia.
12345Is Executive Function and CBT Skills Training for Schizophrenia safe for humans?
The studies on Cognitive Behavioral Social Skills Training (CBSST) and its variations, like CBSST-CCT, suggest that these interventions are generally safe for people with schizophrenia. Participants in these studies did not report significant safety concerns, and the interventions were deemed acceptable, with no modifications needed to the procedures.
12367How is the E-CBSST treatment different from other treatments for schizophrenia?
E-CBSST is unique because it combines executive function training with Cognitive-Behavioral Social Skills Training (CBSST), specifically targeting cognitive deficits and social skills in people with schizophrenia. This approach is designed to improve both cognitive abilities and social functioning, which are often impaired in schizophrenia, making it different from standard treatments that may not address these areas as comprehensively.
12348Eligibility Criteria
This trial is for individuals with schizophrenia, psychosis, or schizoaffective disorder. Participants should be interested in a new therapy that combines cognitive and behavioral skills training with exercises to improve thinking and decision-making.Inclusion Criteria
Clinically stable as operationalized by not having been admitted to a psychiatric hospital within the three months prior to assessment, having had no change in antipsychotic medication dosage within four weeks prior to the baseline assessment, and ascertained to be clinically and medically stable by one of the study investigators
Able to read and converse (with corrected vision or hearing if needed)
Voluntary informed consent to participate
+3 more
Exclusion Criteria
I have a condition that affects my ability to participate in specific brain training programs.
I have been diagnosed with bipolar disorder, depression, or substance abuse in the last 6 months.
I have not had electroconvulsive therapy in the last 6 months.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Executive Function Training
Participants undergo a 2-week Executive Function Training course with 3 sessions per week of computerized exercises and strategy monitoring
2 weeks
6 sessions (in-person)
E-CBSST Cycle 1
Participants complete the first cycle of E-CBSST with 18 sessions, delivered twice a week, including brief EFT at the start of CBSST group sessions
9 weeks
18 sessions (in-person)
E-CBSST Cycle 2
Participants complete the second cycle of E-CBSST with another 18 sessions, delivered twice a week, including brief EFT at the start of CBSST group sessions
9 weeks
18 sessions (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests E-CBSST, which blends Executive Function Training (to enhance thinking and decision-making) with Cognitive-Behavioral Skills Training (for social skills). It aims to see if this can significantly improve daily functioning.
1Treatment groups
Experimental Treatment
Group I: E-CBSSTExperimental Treatment1 Intervention
E-CBSST is the experimental arm in this study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UC San DiegoLa Jolla, CA
Centre for Addiction and Mental HealthToronto, Canada
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Who Is Running the Clinical Trial?
University of California, San DiegoLead Sponsor
Centre for Addiction and Mental HealthCollaborator
References
Neuropsychological predictors of functional outcome in Cognitive Behavioral Social Skills Training for older people with schizophrenia. [2021]Cognitive Behavioral Social Skills Training (CBSST) is a 24-session weekly group therapy intervention to improve functioning in people with schizophrenia. In our prior randomized clinical trial comparing treatment as usual (TAU) with TAU plus group CBSST (Granholm, E., McQuaid, J.R., McClure, F.S., Auslander, L., Perivoliotis, D., Pedrelli, P., Patterson, T., Jeste, D.V., 2005. A randomized controlled trial of cognitive behavioral social skills training for middle-aged and older outpatients with chronic schizophrenia. Am. J. Psychiatry 162, 520-529.), participants with schizophrenia in CBSST showed significantly better functional outcome than participants in TAU. The present study was a secondary analysis of neuropsychological predictors of functional outcome in our prior CBSST trial. We examined (1) whether neuropsychological impairment at baseline moderated functional outcome in CBSST relative to TAU, and (2) whether improvement in neuropsychological abilities mediated improvement in functional outcome in CBSST. Attention, verbal learning/memory, speed of processing, and executive functions were assessed at baseline, end of treatment, and 12-month follow-up. Greater severity of neuropsychological impairment at baseline predicted poorer functional outcome for both treatment groups (nonspecific predictor), but the interaction between severity of neuropsychological impairment and treatment group was not significant (no moderation). Effect sizes for the difference between treatment groups on functional outcome measures at 12-month follow-up were similar for participants with relatively mild (d=.44-.64) and severe (d=.29-.60) neuropsychological impairment. Results also did not support the hypothesis that improvement in neuropsychological abilities mediated improvement in functioning in CBSST. Adding CBSST to standard pharmacologic care, therefore, improved functioning relative to standard care alone, even for participants with severe neuropsychological impairment, and this improvement in functioning was not related to improvement in neuropsychological abilities in CBSST.
Executive functions rehabilitation for schizophrenia: a critical systematic review. [2018]Consistent evidences suggest that poor functional outcomes in schizophrenia are associated with deficits in executive functions (EF). As result cognitive training, remediation and/or rehabilitation (CR) programs have been developed and many theories, methods and approaches have emerged in support of them. This article presents a systematic review of randomized controlled trials (RCT), including EF rehabilitation interventions, with a focus on methodological issues and evidences of EF improvements.
Cognitive-Behavioral Social Skills Training for patients with late-life schizophrenia and the moderating effect of executive dysfunction. [2022]The objectives of this study are to test the efficacy of Cognitive-Behavioral Social Skills Training (CBSST) in enhancing social function in a sample of older patients with schizophrenia, and to assess whether baseline cognition moderates response to CBSST. To address these objectives, we conducted a randomized controlled trial of 63 participants, randomized 1:1 into CBSST or Treatment-As-Usual (TAU). The setting was a community-based geriatric mental health outpatient clinic in Toronto, Ontario, Canada. Data were collected at baseline, and week 18, 36 and 52, between June 2008 and May 2014. Participants were outpatients, aged 60 or older, with a diagnosis of schizophrenia or schizoaffective disorder and no evidence of dementia or other conditions associated with cognitive or functional impairment. The intervention was a weekly group CBSST for 36 weeks. Cognition, including executive function, was assessed at baseline. Modified total score on the Independent Living Skills Survey (ILSS) at 18, 36, and 52 weeks was the primary outcome measure. In a linear mixed model analysis, the ILSS trajectory was better in the CBSST group than the TAU group, with significantly better function at 36 (Cohen's d = 0.75) and 52 weeks (Cohen's d = 0.92). Baseline executive dysfunction moderated CBSST response, whereby participants with more severe executive dysfunction experienced the most improvement in ILSS. CBSST was efficacious in patients with late-life schizophrenia and prevented decline in social function over a one-year period. CBSST was most beneficial for patients with more severe executive dysfunction, i.e., those who needed skills training the most.
Six month durability of targeted cognitive training supplemented with social cognition exercises in schizophrenia. [2022]Deficits in cognition, social cognition, and motivation are significant predictors of poor functional outcomes in schizophrenia. Evidence of durable benefit following social cognitive training is limited. We previously reported the effects of 70 h of targeted cognitive training supplemented with social cognitive exercises (TCT + SCT) verses targeted cognitive training alone (TCT). Here, we report the effects six months after training.
A pilot randomized controlled trial of the Occupational Goal Intervention method for the improvement of executive functioning in patients with treatment-resistant schizophrenia. [2022]Schizophrenia is a chronic disabling mental disorder that involves impairments in several cognitive domains, especially in executive functions (EF), as well as impairments in functional performance. This is particularly true in patients with Treatment-Resistant Schizophrenia (TRS). The aim of this study was to test the efficacy of the Occupational Goal Intervention (OGI) method for the improvement of EF in patients with TRS. In this randomized, controlled, single-blind pilot study, 25 TRS patients were randomly assigned to attend 30 sessions of either OGI or craft activities (control) over a 15-week period and evaluated by the Behavioural Assessment of the Dysexecutive Syndrome (BADS) as the primary outcome and the Direct Assessment of Functional Status (DAFS-BR) as well as the Independent Living Skills Survey (ILSS-BR) as secondary outcomes, all adapted for the Brazilian population. The Positive and Negative Syndrome Scale (PANSS) was used for monitoring symptom severity. Results showed significant statistical differences, favoring the OGI group in terms of improvement on the BADS, both in subtests (Action Program and Key Search) and the total score. Improvements in EFs were observed by families in various dimensions as measured by different subtests of the ILSS-BR inventory. The OGI group showed no significant results in secondary outcomes (DAFS-BR) except in terms of improvement of communication skills. Although preliminary, our results indicate that the OGI method is efficacious and effective for patients with TRS.
Integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training for Negative Symptoms of Psychosis: Effects in a Pilot Randomized Controlled Trial. [2022]Negative symptoms and cognitive impairment in schizophrenia (SZ) remain unmet treatment needs as they are highly prevalent, associated with poor functional outcomes, and resistant to pharmacologic treatment. The current pilot randomized controlled trial examined the efficacy of an integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training (CBSST-CCT) intervention compared to Goal-focused Supportive Contact (SC) on negative symptoms and cognitive performance.
Reducing negative symptoms in schizophrenia: Feasibility and acceptability of a combined cognitive-behavioral social skills training and compensatory cognitive training intervention. [2022]The current study examined the feasibility and acceptability of an integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training (CBSST-CCT) intervention compared with Goal-Focused Supportive Contact (SC) in a pilot randomized controlled trial for people with schizophrenia with high negative symptom severity. The sample included 55 participants from five community settings; masters-level study clinicians delivered interventions on-site. Participants completed assessments of cognitive, functional, and psychiatric symptoms at baseline, mid-treatment, post-treatment (12.5 weeks), and 6-month follow-up. Enrollment goals were not initially met, necessitating the addition of a fifth site; however, all groups and assessments were completed on-site. Study procedures were acceptable, as evidenced by 100% enrollment and completion of baseline assessments following informed consent; however, over 1/3rd of participants dropped out. No modifications were necessary to the intervention procedures and CBSST-CCT fidelity ratings were acceptable. The intervention was deemed acceptable among participants who attended ≥1 session, as evidenced by similar attendance rates in CBSST-CCT compared to SC. Among CBSST-CCT participants, lower positive symptoms were significantly associated with better attendance. Overall, we found mixed evidence for the feasibility and acceptability of the CBSST-CCT protocol in people with schizophrenia with high negative symptoms. Challenges are highlighted and recommendations for future investigations are provided.
Which executive skills should we target to affect social functioning and symptom change? A study of a cognitive remediation therapy program. [2019]This study examined the link between executive function and functional outcome in schizophrenia to identify useful psychological intervention targets and explore how executive function changes affect social functioning and symptoms. Participants from two randomized controlled trials (n = 63) with poor social functioning, positive and negative symptoms, and cognitive impairment completed seven measures of executive function. Three cognitive factors were extracted: verbal working memory, response inhibition speed, and stimulus-driven responding. Participants received individual cognitive remediation therapy (CRT) (n = 18), a control therapy (occupational therapy activities) (n = 14), or treatment as usual (n = 19). Only the CRT group improved on verbal working memory. No group improved on the other factors. Although verbal working memory was significantly associated with social functioning and symptom severity 3 months after baseline, change in this factor did not predict change in either functional outcome. There was a significant interaction between group and the stimulus-driven responding factor, and for the CRT group only, a change to a more externally focused responding style was associated with reduced social problems and symptoms. Regardless of treatment type, increased response inhibition speed was associated with reduced negative symptoms. Stimulus-driven responding and response inhibition speed may therefore make useful targets for intervention.