Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder

Hopital Montfort

Status: Completed

Conditions: Social Anxiety Disorder

Treatments: Behavioral: Cognitive Behavior Group Therapy; Behavioral: Mindfulness-based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02490189

DK-27-02-15

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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97 participants in 2 patient groups

Mindfulness-Based Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-based Intervention

Cognitive Behavior Group Therapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive Behavior Group Therapy