Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder

This study is not yet open for participant recruitment.
Verified November 2012 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Barbara Pavlova, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01736631
First received: November 27, 2012
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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 Intervention
Social Phobia
Bipolar Disorder
Behavioral: Cognitive behavioural therapy (CBT)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder [ Time Frame: up to end of treatment (20 weeks) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and end of treatment (20 weeks) ] [ Designated as safety issue: No ]

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 [ Time Frame: Baseline and end of treatment (20 weeks) ] [ Designated as safety issue: No ]
  • Presence/absence of the social phobia diagnosis [ Time Frame: Baseline and end of treatment (20 weeks) ] [ Designated as safety issue: No ]
    Presence/absence of the social phobia diagnosis as established by Structured Clinical Interview for DSM Disorders

  • Depression symptom change [ Time Frame: Baseline and end of treatment (20 weeks) ] [ Designated as safety issue: No ]
    Depression symptom change as established by the Montgomery-Åsberg Depression Rating Scale and Beck Depression Inventory II

  • Mania symptom change [ Time Frame: Baseline and end of treatment (20 weeks) ] [ Designated as safety issue: No ]
    Change in symptoms of mania as established by the Young Mania Rating Scale


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736631

Contacts
Contact: Barbara Pavlova, PhD DClinPsy (902) 473-2585

Locations
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2E2
Queen Elizabeth II Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2E2
Contact    (902) 473-2585      
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Barbara Pavlova, PhD DClinPsy Capital Health, Canada
  More Information

No publications provided

Responsible Party: Barbara Pavlova, Clinical Psychologist, Assisant Professor, Dalhousie University, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01736631     History of Changes
Other Study ID Numbers: CBTSPBD-001
Study First Received: November 27, 2012
Last Updated: November 28, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Capital District Health Authority, Canada:
social phobia
bipolar disorder
cognitive behavioural therapy

Additional relevant MeSH terms:
Bipolar Disorder
Phobic Disorders
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on April 16, 2014