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Cognitive Behavioral Social Skills Training for Youth at Risk of Psychosis

Primary Purpose

At Risk of Psychosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive behavioral social skills
Psychoeducation
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for At Risk of Psychosis

Eligibility Criteria

14 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • have prodromal criteria in the past 4 years
  • one attenuated psychotic symptom rated 3 or more
  • rating on social functioning <6

Exclusion Criteria:

  • meet criteria for a psychotic disorder neurological disorder IQ<70

Sites / Locations

  • Mathison Centre for Research and Education, University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive behavioral social skills

Psychoeducation

Arm Description

In Cognitive behavioral social skills training (CBSST), skills-based CBT is used to teach individuals how to correct inaccurate dysfunctional thoughts that interfere with goal-directed activities, including defeatist expectancies, low self-efficacy beliefs, and anomalous beliefs. SST focuses on behaviorally-based instruction of interpersonal social skills, utilizing role-modeling, rehearsal, corrective feedback, and positive reinforcement to facilitate learning. In the modified version of CBSST used in this project: 1) we will strengthen the focus on corrective feedback from successful social interactions; 2) focus on normalization and destigmatization of attenuated psychotic symptoms; 3) add motivational interviewing techniques to promote treatment engagement; and 4) use examples and role plays. CBSST will be delivered in three 6-session modules (i.e., Cognitive Skills, Social Skills, and Problem Solving Skills), a total of 18 90-minute group sessions.

The purpose of this alternative treatment is to match CBSST for the nonspecific effects of therapist contact and interest, social interaction and support. Common factors include client expectancy, providing a rationale for change, therapist factors and therapeutic alliance. The psychoeducation group will meet weekly, for a total of 18 90-minute sessions. Therapists will follow brief guidelines as to what they can and cannot do. In each session the therapists will ask how the previous week had been. Any crises will be dealt with, and advice will be offered to help with any immediate problems. No active CBT or SST techniques will be taught or used. Psychoeducational information about high risk for psychosis will be offered. There will be a focus on listening, reflecting and empathizing, and demonstrating uncritical acceptance and genuineness. Social exchanges amongst participants will be encouraged.

Outcomes

Primary Outcome Measures

Change in the Global Social Functioning Scale
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

Change in Defeatist Beliefs
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

Full Information

First Posted
September 3, 2014
Last Updated
May 17, 2022
Sponsor
University of Calgary
Collaborators
The Zucker Hillside Hospital, University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02234258
Brief Title
Cognitive Behavioral Social Skills Training for Youth at Risk of Psychosis
Official Title
Cognitive Behavioral Social Skills Training for Youth at Risk of Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2021 (Actual)
Study Completion Date
August 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
The Zucker Hillside Hospital, University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
At Risk of Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioral social skills
Arm Type
Experimental
Arm Description
In Cognitive behavioral social skills training (CBSST), skills-based CBT is used to teach individuals how to correct inaccurate dysfunctional thoughts that interfere with goal-directed activities, including defeatist expectancies, low self-efficacy beliefs, and anomalous beliefs. SST focuses on behaviorally-based instruction of interpersonal social skills, utilizing role-modeling, rehearsal, corrective feedback, and positive reinforcement to facilitate learning. In the modified version of CBSST used in this project: 1) we will strengthen the focus on corrective feedback from successful social interactions; 2) focus on normalization and destigmatization of attenuated psychotic symptoms; 3) add motivational interviewing techniques to promote treatment engagement; and 4) use examples and role plays. CBSST will be delivered in three 6-session modules (i.e., Cognitive Skills, Social Skills, and Problem Solving Skills), a total of 18 90-minute group sessions.
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
The purpose of this alternative treatment is to match CBSST for the nonspecific effects of therapist contact and interest, social interaction and support. Common factors include client expectancy, providing a rationale for change, therapist factors and therapeutic alliance. The psychoeducation group will meet weekly, for a total of 18 90-minute sessions. Therapists will follow brief guidelines as to what they can and cannot do. In each session the therapists will ask how the previous week had been. Any crises will be dealt with, and advice will be offered to help with any immediate problems. No active CBT or SST techniques will be taught or used. Psychoeducational information about high risk for psychosis will be offered. There will be a focus on listening, reflecting and empathizing, and demonstrating uncritical acceptance and genuineness. Social exchanges amongst participants will be encouraged.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral social skills
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Primary Outcome Measure Information:
Title
Change in the Global Social Functioning Scale
Description
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
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Change in Defeatist Beliefs
Description
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
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: have prodromal criteria in the past 4 years one attenuated psychotic symptom rated 3 or more rating on social functioning <6 Exclusion Criteria: meet criteria for a psychotic disorder neurological disorder IQ<70
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean M Addington, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mathison Centre for Research and Education, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4Z6
Country
Canada

12. IPD Sharing Statement

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Cognitive Behavioral Social Skills Training for Youth at Risk of Psychosis

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