Clinical trial NCT02490189: Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder
Official title: Comparative Trial of a Mindfulness-based Intervention Versus Cognitive Behavior Therapy for Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Lead sponsor: Hopital Montfort
Sponsor class: OTHER
Collaborators: name: Ontario Mental Health Foundation
name: University of Ottawa
First posted: 2015-07-03
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Liebowitz Social Anxiety Scale
timeFrame: Change from baseline to week 12 and 6-month follow-up
Secondary outcomes:
measure: Social Phobia Inventory
timeFrame: Change from baseline to week 12 and 6-month follow-up
measure: Clinical Global Impression Improvement Ratings
timeFrame: Change from baseline to week 12 and 6-month follow-up
measure: Beck Depression Inventory
timeFrame: Change from baseline to week 12 and 6-month-follow-up
measure: Social Adjustment Scale-Self Report Revised
timeFrame: Change from baseline to week 12 and 6-month follow-up
measure: Rosenberg Self-Esteem Scale
timeFrame: Change from baseline to week 12 and 6-month follow-up
measure: Satisfaction with Life Questionnaire
timeFrame: Change from baseline to week 12 and 6-month follow-up
Other outcomes:
measure: Self-Compassion Scale-Short Form
timeFrame: Change from baseline to week 12 and 6-month follow-up
measure: Five-Facet Mindfulness Questionnaire
timeFrame: Change from baseline to week 12 and 6-month follow-up
Locations:
city: Ottawa
country: Canada
facility: Hopital Montfort
state: Ontario
city: Ottawa
country: Canada
facility: Montfort Hospital
state: Ontario
Study officials:
affiliation: Hopital Montfort
name: Diana Koszycki, PhD
role: PRINCIPAL_INVESTIGATOR
References: