Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736631
• Other study ID #: CBTSPBD-001
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: September 9, 2022

Study information

• Verified date: June 2017
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 9, 2022
• Est. primary completion date: January 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Phobia, Social
• Phobic Disorders
• Social Phobia

Intervention

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.

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Change on the Social Phobia Inventory (SPIN)		Baseline and end of treatment (20 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Mania symptom change	Change in symptoms of mania as established by the Young Mania Rating Scale	Baseline and end of treatment (20 weeks)