Back to results

Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder

Primary Purpose

Social Phobia, Bipolar Disorder

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Cognitive behavioural therapy (CBT)

About this trial

This is an interventional treatment trial for Social Phobia focused on measuring social phobia, bipolar disorder, cognitive behavioural therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Queen Elizabeth II Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive behavioural therapy

Arm Description

Cognitive behavioural therapy for social phobia in people with bipolar disorder

Outcomes

Primary Outcome Measures

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

Change on the Social Phobia Inventory (SPIN)

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

Presence/absence of the social phobia diagnosis

Presence/absence of the social phobia diagnosis as established by Structured Clinical Interview for DSM Disorders

Depression symptom change

Depression symptom change as established by the Montgomery-Åsberg Depression Rating Scale and Beck Depression Inventory II

Mania symptom change

Change in symptoms of mania as established by the Young Mania Rating Scale

Full Information

NCT ID

NCT01736631

First Posted

November 27, 2012

Last Updated

November 9, 2022

Sponsor

Nova Scotia Health Authority

1. Study Identification

Unique Protocol Identification Number

NCT01736631

Brief Title

Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

March 2013 (Actual)

Primary Completion Date

January 24, 2019 (Actual)

Study Completion Date

September 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Social Phobia, Bipolar Disorder

Keywords

social phobia, bipolar disorder, cognitive behavioural therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive behavioural therapy

Arm Type

Experimental

Arm Description

Cognitive behavioural therapy for social phobia in people with bipolar disorder

Intervention Type

Behavioral

Intervention Name(s)

Cognitive behavioural therapy (CBT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder

Description

Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder will be assessed as proportion of offered sessions attended

Time Frame

up to end of treatment (20 weeks)

Title

Change on the Social Phobia Inventory (SPIN)

Time Frame