Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder

Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder; Social Phobia
• Intervention / Treatment: Behavioral: Cognitive behavioural therapy (CBT)

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2E2
      • Queen Elizabeth II Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive behavioural therapy; Cognitive behavioural therapy for social phobia in people with bipolar disorder	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder	Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder will be assessed as proportion of offered sessions attended	up to end of treatment (20 weeks)
Change on the Social Phobia Inventory (SPIN)		Baseline and end of treatment (20 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on the Liebowitz Social Anxiety Scale Scale Self-Report; Social Phobia Scale & Social Interaction Anxiety Scale; Social Phobia and Anxiety Inventory		Baseline and end of treatment (20 weeks)
Presence/absence of the social phobia diagnosis	Presence/absence of the social phobia diagnosis as established by Structured Clinical Interview for DSM Disorders	Baseline and end of treatment (20 weeks)
Depression symptom change	Depression symptom change as established by the Montgomery-Åsberg Depression Rating Scale and Beck Depression Inventory II	Baseline and end of treatment (20 weeks)
Mania symptom change	Change in symptoms of mania as established by the Young Mania Rating Scale	Baseline and end of treatment (20 weeks)

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Barbara Pavlova, PhD DClinPsy, Capital Health, Canada

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): January 24, 2019
• Study Completion (Actual): September 9, 2022

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: November 28, 2012
• First Posted (Estimate): November 29, 2012

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: bipolar disorder; cognitive behavioural therapy; social phobia
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Anxiety Disorders; Bipolar and Related Disorders; Disease; Bipolar Disorder; Phobia, Social; Phobic Disorders
• Other Study ID Numbers: CBTSPBD-001