Clinical trial NCT01736631: 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
Overall status: COMPLETED
Phase: NA
Conditions: Social Phobia
Bipolar Disorder
Keywords: social phobia
bipolar disorder
cognitive behavioural therapy
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder
timeFrame: up to end of treatment (20 weeks)
measure: Change on the Social Phobia Inventory (SPIN)
timeFrame: Baseline and end of treatment (20 weeks)
Secondary outcomes:
measure: Change on the Liebowitz Social Anxiety Scale Scale Self-Report; Social Phobia Scale & Social Interaction Anxiety Scale; Social Phobia and Anxiety Inventory
timeFrame: Baseline and end of treatment (20 weeks)
measure: Presence/absence of the social phobia diagnosis
timeFrame: Baseline and end of treatment (20 weeks)
measure: Depression symptom change
timeFrame: Baseline and end of treatment (20 weeks)
measure: Mania symptom change
timeFrame: Baseline and end of treatment (20 weeks)
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Capital Health, Canada
name: Barbara Pavlova, PhD DClinPsy
role: PRINCIPAL_INVESTIGATOR
References: