Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02490189
• Date of registration: 30/06/2015
• Prospective Registration: Yes
• Primary sponsor: Hopital Montfort
• Public title: Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder
• Scientific title: Comparative Trial of a Mindfulness-based Intervention Versus Cognitive Behavior Therapy for Social Anxiety Disorder
• Date of first enrolment: July 25, 2015
• Target sample size: 97
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02490189
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Diana Koszycki, PhD
• Affiliation: Hopital Montfort

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Social Anxiety Disorder

Intervention(s)

Behavioral: Mindfulness-based Intervention

Behavioral: Cognitive Behavior Group Therapy

Primary Outcome(s)

Liebowitz Social Anxiety Scale [Time Frame: Change from baseline to week 12 and 6-month follow-up]

Secondary Outcome(s)

Clinical Global Impression Improvement Ratings [Time Frame: Change from baseline to week 12 and 6-month follow-up]

Social Phobia Inventory [Time Frame: Change from baseline to week 12 and 6-month follow-up]

Rosenberg Self-Esteem Scale [Time Frame: Change from baseline to week 12 and 6-month follow-up]

Social Adjustment Scale-Self Report Revised [Time Frame: Change from baseline to week 12 and 6-month follow-up]

Satisfaction with Life Questionnaire [Time Frame: Change from baseline to week 12 and 6-month follow-up]

Beck Depression Inventory [Time Frame: Change from baseline to week 12 and 6-month-follow-up]

Secondary ID(s)

DK-27-02-15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Ottawa

Ontario Mental Health Foundation