Group Cognitive-behavioral Intervention for Social Anxiety in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Manualized Group Cognitive-behavioral Intervention for Social Anxiety in Schizophrenia: An Efficacy Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376596
• Other study ID #: 10-273-PSY
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2011
• Est. completion date: January 2013

Study information

• Verified date: October 2022
• Source: Douglas Mental Health University Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Schizophrenia
• Social Anxiety

Intervention

Behavioral:
• Cognitive-Behavioral Therapy based intervention immediately
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.
• Wait list
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

Locations

Country	Name	City	State
Canada	RUIS McGill CBT Teaching & Research Program	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Douglas Mental Health University Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	13-week intervention program