NCT01736631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2019

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2022

Completed
Last Updated

November 14, 2022

Status Verified

June 1, 2017

Enrollment Period

5.9 years

First QC Date

November 27, 2012

Last Update Submit

November 9, 2022

Conditions

Social PhobiaBipolar Disorder

Keywords

social phobiabipolar disordercognitive behavioural therapy

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Change on the Social Phobia Inventory (SPIN)

    Baseline and end of treatment (20 weeks)

Secondary Outcomes (4)

  • 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)

  • Presence/absence of the social phobia diagnosis

    Baseline and end of treatment (20 weeks)

  • Depression symptom change

    Baseline and end of treatment (20 weeks)

  • Mania symptom change

    Baseline and end of treatment (20 weeks)

Study Arms (1)

Cognitive behavioural therapy

EXPERIMENTAL

Cognitive behavioural therapy for social phobia in people with bipolar disorder

Behavioral: Cognitive behavioural therapy (CBT)

Interventions

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.

Cognitive behavioural therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2E2, Canada

Location

MeSH Terms

Conditions

Phobia, SocialBipolar Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Barbara Pavlova, PhD DClinPsy

    Capital Health, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

November 29, 2012

Study Start

March 1, 2013

Primary Completion

January 24, 2019

Study Completion

September 9, 2022

Last Updated

November 14, 2022

Record last verified: 2017-06

Locations

CA(1)