Group Cognitive-behavioral Intervention for Social Anxiety in Schizophrenia
Primary Purpose
Social Anxiety, Schizophrenia
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy based intervention immediately
Wait list
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety focused on measuring Remission, Psychosocial Functioning, Symptoms reduction
Eligibility Criteria
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.
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.
Sites / Locations
- RUIS McGill CBT Teaching & Research Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CBT-based Intervention
Treatment as usual
Arm Description
Contrast the impact of a CBT intervention for the treatment of social anxiety in schizophrenia with standard care (care as usual)
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Positive and negative symptoms of schizophrenia reduction
To measure the effect of a group CBT intervention for social anxiety on positive and negative symptoms of schizophrenia.
Full Information
NCT ID
NCT01376596
First Posted
June 16, 2011
Last Updated
October 21, 2022
Sponsor
Douglas Mental Health University Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT01376596
Brief Title
Group Cognitive-behavioral Intervention for Social Anxiety in Schizophrenia
Official Title
Manualized Group Cognitive-behavioral Intervention for Social Anxiety in Schizophrenia: An Efficacy Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Douglas Mental Health University Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety, Schizophrenia
Keywords
Remission, Psychosocial Functioning, Symptoms reduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT-based Intervention
Arm Type
Experimental
Arm Description
Contrast the impact of a CBT intervention for the treatment of social anxiety in schizophrenia with standard care (care as usual)
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy based intervention immediately
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wait list
Intervention Description
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
Primary Outcome Measure Information:
Title
Social anxiety symptom reduction
Description
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
Time Frame
13-week intervention program
Secondary Outcome Measure Information:
Title
Positive and negative symptoms of schizophrenia reduction
Description
To measure the effect of a group CBT intervention for social anxiety on positive and negative symptoms of schizophrenia.
Time Frame
13-week intervention program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Facility Information:
Facility Name
RUIS McGill CBT Teaching & Research Program
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
12. IPD Sharing Statement
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Group Cognitive-behavioral Intervention for Social Anxiety in Schizophrenia
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