Group Cognitive-behavioral Intervention for Social Anxiety in Schizophrenia

Phase 1

Completed

• Conditions: Social Anxiety; Schizophrenia
• Interventions: Behavioral: Wait list; Behavioral: Cognitive-Behavioral Therapy based intervention immediately

• Registration Number: NCT01376596
• Lead Sponsor: Douglas Mental Health University Institute

Brief Summary

This study will explore the helpfulness of a short psychological group treatment called cognitive-behavioral therapy, or CBT. CBT is a form of therapy that is very structured and it aims to improve difficulties that are related to behaviors and emotions by first working on identifying and changing negative inaccurate thoughts. The main goal of this intervention is to see if group CBT reduces the symptoms of social anxiety in people with schizophrenia so that they can improve their social functioning and help their psychotic symptoms. The study compares the usefulness of adding CBT to standard services.

Detailed Description

Social anxiety is highly prevalent in people with schizophrenia and represents a major obstacle to positive functional outcomes. Social anxiety is a treatable condition but has, in the context of psychosis, received only scant attention thus far. Current existing manualized treatment for social anxiety may not be optimal for people with schizophrenia for a number of reasons described above. An adapted CBT intervention for schizophrenia must target the stigma attached to the illness, the presence of poor social skills, the presence of delusional and persecutory ideas, possible limited reading abilities, and associated cognitive deficits. The investigators propose to develop and test an adapted group CBT for social anxiety. The main objective of this research proposal is to contrast the impact of a CBT intervention for the treatment of social anxiety in schizophrenia with standard care (care as usual) on reducing symptoms of social anxiety. Considering the relationship between certain characteristics of social anxiety (e.g. social withdrawal) with diminished quality of life and poor functional outcome, a secondary objective is to examine the impact of reduced social anxiety on functional outcome.

Study Timeline

• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Study Start: 2011-08
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-21
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Diagnosis of a schizophrenia spectrum disorder; aged 18-50; be able to read and write at an intermediate level (Education > 8 years or more); social anxiety scores above 34 for the SIAS, above 19 for the SPIN and above 20 for the BSPS; and the the presence of observable clinical symptoms supporting the diagnosis of a social anxiety disorder on Axis I.

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Exclusion Criteria

• Diagnosis of affective psychosis; currently clinically stable [score of 3 or less of the SAPS ratings; Global Assessment Scale score (Endicott, et al., 1976) of ≥ 50]; have no significant presence of social anxiety (score on scales below cut-off); hospitalized or hospitalized at the time of recruitment; and a change medication within the past 6 weeks.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual	Wait list	Usual care received by patients at clinic/hospital - randomized to a wait list to receive the CBT intervention at the end of the group that received the intervention immediately
CBT-based Intervention	Cognitive-Behavioral Therapy based intervention immediately	Contrast the impact of a CBT intervention for the treatment of social anxiety in schizophrenia with standard care (care as usual)

Primary Outcome Measures

Name	Time	Method
Social anxiety symptom reduction	13-week intervention program	To compare the effectiveness in social anxiety symptom reduction of a 13-week group CBT for social anxiety adapted for people with schizophrenia relative to a control condition involving participants who will be receiving standard care only, followed by the proposed intervention on a wait-list basis

Secondary Outcome Measures

Name	Time	Method
Positive and negative symptoms of schizophrenia reduction	13-week intervention program	To measure the effect of a group CBT intervention for social anxiety on positive and negative symptoms of schizophrenia.

Trial Locations

Locations (1)

RUIS McGill CBT Teaching & Research Program; 🇨🇦 Montreal, Quebec, Canada