NCT02490189

Brief Summary

To conduct a prospective, randomized trial to compare the efficacy of a group mindfulness-based intervention adapted for social anxiety disorder (MBI-SAD) versus cognitive behavior group therapy (CBGT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

June 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

July 25, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2018

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

2.4 years

First QC Date

June 30, 2015

Last Update Submit

February 20, 2018

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • Liebowitz Social Anxiety Scale

    A 24-item clinician-rated scale that assesses fear and avoidance of social performance and social situations.

    Change from baseline to week 12 and 6-month follow-up

Secondary Outcomes (6)

  • Social Phobia Inventory

    Change from baseline to week 12 and 6-month follow-up

  • Clinical Global Impression Improvement Ratings

    Change from baseline to week 12 and 6-month follow-up

  • Beck Depression Inventory

    Change from baseline to week 12 and 6-month-follow-up

  • Social Adjustment Scale-Self Report Revised

    Change from baseline to week 12 and 6-month follow-up

  • Rosenberg Self-Esteem Scale

    Change from baseline to week 12 and 6-month follow-up

  • +1 more secondary outcomes

Other Outcomes (2)

  • Self-Compassion Scale-Short Form

    Change from baseline to week 12 and 6-month follow-up

  • Five-Facet Mindfulness Questionnaire

    Change from baseline to week 12 and 6-month follow-up

Study Arms (2)

Mindfulness-Based Intervention

EXPERIMENTAL

Participants in the mindfulness-based intervention arm will receive 12 weekly sessions of 2 to 2.5 hours duration. The intervention will be delivered in a group format. Participants will be assigned weekly homework.

Behavioral: Mindfulness-based Intervention

Cognitive Behavior Group Therapy

ACTIVE COMPARATOR

Participants in the cognitive behavior group therapy arm will receive 12 weekly sessions of 2 to 2.5 hours in duration. Participants will be assigned weekly homework.

Behavioral: Cognitive Behavior Group Therapy

Interventions

Mindfulness-based InterventionBEHAVIORAL

Twelve week group intervention that includes training in mindfulness meditation, self-compassion and mindful exposure.

Mindfulness-Based Intervention
Cognitive Behavior Group TherapyBEHAVIORAL

Twelve week group intervention that focuses on the interaction between thoughts, feelings, and behaviors.

Also known as: CBGT
Cognitive Behavior Group Therapy

Eligibility Criteria

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

You may qualify if:

  • DSM-5 diagnosis of social anxiety disorder (SAD) of at least moderate severity
  • Montgomery Asberg Depression Rating Scale score ≤ 25
  • Comorbid depressive disorders, panic disorder, agoraphobia, generalized anxiety disorder, specific phobias, eating disorders are allowed as long as the SAD is primary and predominates the clinical picture.

You may not qualify if:

  • Coexisting medical conditions that can alter the clinical presentation of SAD (e.g. Parkinson's disease)
  • Lifetime history of bipolar disorder or psychotic symptoms
  • Substance-related disorders in the last 12 months
  • Acutely suicidal or history of suicide attempt in the past five years
  • History of non-suicidal self-injurious behavior in the last 12 months
  • Currently receiving psychotherapy
  • Currently engaged in a regular meditation or yoga practice
  • Unable to attend weekly group sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Montfort

Ottawa, Ontario, K1K 0T1, Canada

Location

Montfort Hospital

Ottawa, Ontario, K1K 0T1, Canada

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Diana Koszycki, PhD

    Hopital Montfort

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Research Chair in Mental Health

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 3, 2015

Study Start

July 25, 2015

Primary Completion

December 15, 2017

Study Completion

February 21, 2018

Last Updated

February 22, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)