Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-25

Study Completion Date

2018-02-21

Brief Summary

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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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Detailed Description

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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.

Conditions

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Social Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindfulness-Based Intervention

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.

Group Type EXPERIMENTAL

Mindfulness-based Intervention

Intervention Type BEHAVIORAL

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

Cognitive Behavior Group Therapy

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.

Group Type ACTIVE_COMPARATOR

Cognitive Behavior Group Therapy

Intervention Type BEHAVIORAL

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

Interventions

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Mindfulness-based Intervention

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

Intervention Type BEHAVIORAL

Cognitive Behavior Group Therapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

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CBGT

Eligibility Criteria

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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.

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No