Cognitive Behavioral Social Skills Training for Youth at Risk of Psychosis
- Conditions
- At Risk of Psychosis
- Registration Number
- NCT02234258
- Lead Sponsor
- University of Calgary
- Brief Summary
Schizophrenia and other psychotic disorders are serious and debilitating mental illnesses that incur substantial suffering for patients and major challenges to the investigators health care and legal systems. The prodrome is the period prior to onset of psychosis when functional decline and clinical symptoms gradually emerge. The presence of a clinical high-risk (CHR) syndrome in young adults is associated with heightened risk (25-35%) for the later development of psychosis, and for those who do not necessarily go on to develop a psychotic illness, research has suggested that the majority continue to have fluctuating subthreshold symptoms and poor social and role functioning. There are no specific treatments to help with these functional difficulties. However, recent findings suggest that in people with schizophrenia, Cognitive Behavioral and Social Skills Training (CBSST) leads to significantly greater increase in the frequency of social functioning activities compared to treatment as usual or goal-focused supportive therapy, and preliminary data suggest CBSST is a feasible treatment for CHR. This proposal is a competitive application for a three-site, longitudinal study aimed at testing the effectiveness and feasibility as well as mediators and mechanisms of action of a manualized CBSST intervention that will target functional difficulties associated with clinical risk states for psychosis. The goals are 1) to examine whether CBSST compared to a placebo intervention (psychoeducation) matched for group involvement and therapist time improves functioning in youth at CHR and 2) to determine whether reduction in defeatist beliefs and improvement in social competence mediate change in psychosocial functioning in CHR youth in the CBSST. In this single-blind randomized 2-arm trial participants will be randomized to one of two treatments: CBSST, an 18-week group comprised of three modules; 1) Cognitive Skills; 2) Social Skills; and 3) Problem Solving, or a psychoeducation support group that does not teach active cognitive behavioral therapy or social skills training. Over a five-year period, the multi-site collaboration will follow large CHR sample that will undergo comprehensive assessments of psychosocial and behavioral changes, to examine changes in social and role functioning, as well as symptom changes from baseline to the end of treatment, and to 6 month follow-up. This approach will demonstrate the feasibility of a treatment for which it is easy to train therapists and which can readily be disseminated to regular clinical community practice. In addition, it will provide insights into likely approaches to halting or mitigating the pathological process and advance the investigators understanding of risk prediction; both critical steps in prevention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 203
- have prodromal criteria in the past 4 years
- one attenuated psychotic symptom rated 3 or more
- rating on social functioning <6
- meet criteria for a psychotic disorder neurological disorder IQ<70
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in the Global Social Functioning Scale 6 and 12 months This is a clinical rating scale that will be given to all participants at baseline, then 6 months which is the end of treatment and then 6 months after the end of treatment so approximately 12 months after baseline to determine if there is an improvement in social functioning
- Secondary Outcome Measures
Name Time Method Change in Defeatist Beliefs 6 and 12 months This is a clinical rating scale that will be administer at the end of treatment (6 months) and 6 months after the end of treatment (12 months). This will be administered to all participants
Trial Locations
- Locations (1)
Mathison Centre for Research and Education, University of Calgary
🇨🇦Calgary, Alberta, Canada
Mathison Centre for Research and Education, University of Calgary🇨🇦Calgary, Alberta, Canada