ClinicalTrials.gg
CompletedNCT01736631Updated Nov 14, 2022

Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder

An interventional study of Cognitive behavioural therapy (CBT) in Social Phobia and Bipolar Disorder, sponsored by Nova Scotia Health Authority. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-14.

Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 29 studies in Phobia, Social with a site in Canada — none open to participants now, 2 under way, none of them phase 3. Phobia, Social · Canada.

Enrollment
23rd of 29
9 · median 60
Started
2013
with 1 other
No phase
15 of 29
none open now
Registered
11th of 29
by date
Lead sponsor
2 of 29
Nova Scotia Health Authority

Among the 29 studies in Phobia, Social with a site in Canada, this one is the 23rd largest by enrollment, is one of 2 that started in 2013, is one of 15 with no phase, and was the 11th registered.

Phobia, Social

368 studies on the registry are indexed under Phobia, Social; 59 are open to participants now.

Browse Phobia, Social studies →

Open to participants now

None of the 29 studies in Phobia, Social with a site in Canada is open now. The open studies under Phobia, Social, anywhere →

Who these studies take

Of the 46 Phobia, Social studies recruiting now, 10 (22%) set no upper age limit and 34 (74%) stop at 75 or younger; 14 take children under 18; 8 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 29 studies in Phobia, Social with a site in Canada as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Social Phobia
  • Bipolar Disorder

Keywords

  • social phobia
  • bipolar disorder
  • cognitive behavioural therapy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A diagnosis of bipolar disorder I or II according to 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Cognitive behavioural therapy

    Cognitive behavioural therapy for social phobia in people with bipolar disorder

    Behavioral: Cognitive behavioural therapy (CBT)

Interventions

  • BehavioralCognitive 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to end of treatment (20 weeks)

  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

    Presence/absence of the social phobia diagnosis as established by Structured Clinical Interview for DSM Disorders

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

  3. Depression symptom change

    Depression symptom change as established by the Montgomery-Åsberg Depression Rating Scale and Beck Depression Inventory II

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

  4. Mania symptom change

    Change in symptoms of mania as established by the Young Mania Rating Scale

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

07

Study locations

1 site
  • Queen Elizabeth II Health Sciences Centre
    Halifax, Nova Scotia B3H 2E2, Canada
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2013 to primary completion in Jan 2019, 70 months.

Of 142 non-industry interventional studies with no phase under Phobia, Social, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 44. This study's 70 months is above that.

Counting every sponsor, half of 148 studies reached it within 28 months; a quarter within 14 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2012
First posted
Nov 29, 2012
StartActual
Mar 2013
Primary completionActual
Jan 24, 2019
CompletionActual
Sep 9, 2022
Last update
Nov 14, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01736631
Responsible party
Sponsor
First posted
Nov 29, 2012
Start date
Mar 2013
Primary completion
Jan 24, 2019
Completion
Sep 9, 2022
Last update
Nov 14, 2022

Study contacts

Barbara Pavlova, PhD DClinPsy
principal investigator · Capital Health, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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