Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder

Sponsor

Nova Scotia Health Authority (Other)

Overall Status

Unknown status

CT.gov ID

NCT01736631

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Social Phobia Bipolar Disorder	Behavioral: Cognitive behavioural therapy (CBT)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2013

Anticipated Primary Completion Date :

Jan 1, 2019

Anticipated Study Completion Date :

Jan 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 [Baseline and end of treatment (20 weeks)]
Presence/absence of the social phobia diagnosis as established by Structured Clinical Interview for DSM Disorders
Depression symptom change [Baseline and end of treatment (20 weeks)]
Depression symptom change as established by the Montgomery-Åsberg Depression Rating Scale and Beck Depression Inventory II
Mania symptom change [Baseline and end of treatment (20 weeks)]
Change in symptoms of mania as established by the Young Mania Rating Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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