Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder

NCT ID: NCT01736631

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2022-09-09

Brief Summary

We are doing this study to find out how well cognitive behavioural therapy for social phobia works in people with bipolar disorder, who also have social phobia.

Detailed Description

Social phobia is a very prevalent anxiety disorder in people with bipolar disorder and is associated with adverse outcomes. Yet, social phobia is treatable by cognitive behavioural therapy or antidepressant medication. As antidepressants are often contra-indicated in people with bipolar disorder, cognitive behavioural therapy is the likely first choice treatment for social phobia in this population. However, people with bipolar disorder were excluded from previous clinical trials on treatment of social phobia. Our aim is to evaluate the acceptability and to provide a rough estimate of efficacy of cognitive behavioural therapy protocol for social phobia in people with bipolar disorder in a systematic case series. We will also prepare pilot data for evaluating the impact of treatment of comorbid social phobia on the long-term course of bipolar disorder.

Conditions

Social Phobia; Bipolar Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive behavioural therapy

Cognitive behavioural therapy for social phobia in people with bipolar disorder

Group Type: EXPERIMENTAL

Cognitive behavioural therapy (CBT)

Intervention Type: BEHAVIORAL

The CBT intervention will follow the model of social phobia by Clark \& Wells (Clark \& Wells, 1995; Clark, 2005). The main elements of CBT for social phobia include reducing self-focus, dropping safety behaviours, and testing negative cognitions.

Interventions

Cognitive behavioural therapy (CBT)

The CBT intervention will follow the model of social phobia by Clark \& Wells (Clark \& Wells, 1995; Clark, 2005). The main elements of CBT for social phobia include reducing self-focus, dropping safety behaviours, and testing negative cognitions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• A diagnosis of bipolar disorder I or II according to DSM-IV criteria and established in a structured interview
• Bipolar disorder in remission for at least 12 weeks; defined as absence of depressive or manic episode according to DSM-IV criteria established in a structured interview and confirmed by Montgomery-Åsberg Depression Rating Scale score ≤ 12 and Young Mania Rating Scale score ≤ 7
• Stable medication regime for at least 4 weeks prior to commencing CBT
• Current diagnosis of social phobia according to DSM-IV criteria and established in a structured interview, including duration of social phobia of at least 6 months irrespective of age.
• Social phobia is one of the primary complains (when bipolar disorder is in remission), justifying a therapeutic focus on this disorder.
• Ability and willingness to consent to treatment
• Ability to speak and write English

Exclusion Criteria

• Current substance use disorder
• A previous adequate course of CBT for social phobia (at least 8 sessions) delivered by a trained therapist
• Currently receiving any psychological therapy
• Cognitive impairment that would preclude psychological therapy
• Actively suicidal

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Pavlova, PhD DClinPsy

Role: PRINCIPAL_INVESTIGATOR

Capital Health, Canada

Locations

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

CBTSPBD-001

Identifier Type: -

Identifier Source: org_study_id