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Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT01736631
Recruitment Status : Recruiting
First Posted : November 29, 2012
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Barbara Pavlova, Nova Scotia Health Authority

November 27, 2012
November 29, 2012
June 21, 2017
March 2013
January 2019   (Final data collection date for primary outcome measure)
  • Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder [ Time Frame: 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) [ Time Frame: Baseline and end of treatment (20 weeks) ]
Same as current
Complete list of historical versions of study NCT01736631 on ClinicalTrials.gov Archive Site
  • 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) ]
  • Presence/absence of the social phobia diagnosis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and end of treatment (20 weeks) ]
    Change in symptoms of mania as established by the Young Mania Rating Scale
Same as current
Not Provided
Not Provided
 
Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder
Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder: A Pilot Study
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.
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Social Phobia
  • 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.
Experimental: Cognitive behavioural therapy
Cognitive behavioural therapy for social phobia in people with bipolar disorder
Intervention: Behavioral: Cognitive behavioural therapy (CBT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Same as current
January 2019
January 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Barbara Pavlova, PhD DClinPsy (902) 473-2585
Canada
 
 
NCT01736631
CBTSPBD-001
No
Not Provided
Not Provided
Barbara Pavlova, Nova Scotia Health Authority
Nova Scotia Health Authority
Not Provided
Principal Investigator: Barbara Pavlova, PhD DClinPsy Capital Health, Canada
Nova Scotia Health Authority
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP