Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder

Study Overview
=================
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.

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

Conditions
-----------------
Social Phobia, Bipolar Disorder

Intervention / Treatment
-----------------
* Behavioral: Cognitive behavioural therapy (CBT)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioural therapy<br>Cognitive behavioural therapy for social phobia in people with bipolar disorder | Behavioral: Cognitive behavioural therapy (CBT)<br>* 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.<br>|

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
social phobia, bipolar disorder, cognitive behavioural therapy