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Completed

NCT Number: NCT01736631

Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder

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.

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Key information

Conditions

Social Phobia Anxiety Disorders Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Phobia, Social Phobic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2E2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioural Therapy (CBT)

Behavioral

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 outcomes

  1. 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

  2. Change on the Social Phobia Inventory (SPIN)

    Time frame: Baseline and end of treatment (20 weeks)

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2022
First posted
Nov 29, 2012
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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