Group Cognitive-behavioral Intervention for Social Anxiety in Schizophrenia

NCT01376596 | Completed Phase 1 DMC

• 1 other identifier: 10-273-PSY
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety; Schizophrenia

Keywords

Remission; Psychosocial Functioning; Symptoms reduction

Outcome Measures

Primary Outcomes (1)

• Social anxiety symptom reduction

  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

  13-week intervention program

Secondary Outcomes (1)

• Positive and negative symptoms of schizophrenia reduction

  13-week intervention program

Study Arms (2)

CBT-based Intervention

EXPERIMENTAL

Contrast the impact of a CBT intervention for the treatment of social anxiety in schizophrenia with standard care (care as usual)

Behavioral: Cognitive-Behavioral Therapy based intervention immediately

Treatment as usual

ACTIVE COMPARATOR

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

Behavioral: Wait list

Interventions

Cognitive-Behavioral Therapy based intervention immediately BEHAVIORAL

This intervention will include: i) Psychoeducation on social anxiety disorder; ii) Cognitive Restructuring: Identify negative thoughts that occur before, during, or after anxiety-provoking situations; Evaluate the accuracy of their thoughts in the light of data derived from Socratic questioning or as a result of so-called behavioral experiments; and derive rational alternative thoughts based on the acquired information; iii) Exposure component, which focuses on the collection of information that will allow patients to revise their judgments about the degree of risk to which they are exposed in feared situations, challenge their dysfunctional beliefs about the self relative to the illness and their self-efficacy (social status related), and iv) Use of Thought Records to identify, explore and dispute negative thoughts about dysfunctional self-identity and core beliefs related to the onset and presence of diagnosis of schizophrenia.

CBT-based Intervention

Wait list BEHAVIORAL

The group receiving treatment as usual (TAU) will be put on a wait list to receive the CBT intervention at the end of the experimental group, the one receiving the intervention immediately

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Douglas Mental Health University Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

RUIS McGill CBT Teaching & Research Program

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatry professor

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 20, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

CA (1)