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Completed

NCT Number: NCT02490189

Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder

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).

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Montfort, Ottawa, Ontario, Canada

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About this study

The main aim of this comparative trial is to determine if the MBI-SAD will be noninferior to CBGT in improving core symptoms of social anxiety disorder, depressive symptoms, self, esteem, disability and quality of life. A secondary aim is to examine whether treatment gains are maintained over a 6-month period. Exploratory aims of the study are to: 1) determine if the MBI-SAD enhances self-compassion and mindfulness relative to CBGT; 2) determine if changes in self-compassion and mindfulness mediate the clinical response to the MBI-SAD; and 3) explore moderators of treatment response.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • Coexisting Axis I disorders excluding those listed in the inclusion criteria
  • 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

Treatment and study plan

Mindfulness-based Intervention

Behavioral

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

Cognitive behavior group therapy

Behavioral

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

Other names: CBGT

Primary outcomes

  1. Liebowitz Social Anxiety Scale

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

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

Secondary outcomes

  1. Social Phobia Inventory

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

    A 17-item self-report scale that assesses symptom domains of social anxiety.

  2. Clinical Global Impression Improvement Ratings

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

    A 7-point clinician-rated scale that assesses level of clinical improvement.

  3. Beck Depression Inventory

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

    A 21-item self-report measure of severity of depressive symptoms.

  4. Social Adjustment Scale-Self Report Revised

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

    A 49-item self-report scale that assesses functional impairment in multiple roles.

  5. Rosenberg Self-Esteem Scale

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

    A 10-item self-report measure of self-esteem.

  6. Satisfaction with Life Questionnaire

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

    A 5-item self-report scale that assesses overall satisfaction with life.

Other outcomes

  1. Self-Compassion Scale-Short Form

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

    A 12-item self-report scale that captures how respondents perceive their actions towards themselves in difficult times.

  2. Five-Facet Mindfulness Questionnaire

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

    A 39-item self-report inventory that assesses different facets of mindfulness.

Sponsors and collaborators

Lead sponsor

Hopital Montfort

Other

Collaborators

  • Ontario Mental Health Foundation
  • University of Ottawa

Registry information

Official study title

Comparative Trial of a Mindfulness-based Intervention Versus Cognitive Behavior Therapy for Social Anxiety Disorder

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jul 3, 2015
Registry last updated
Feb 22, 2018

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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