Stress Management and Resiliency Training (SMART) Integrated Into Comprehensive Treatment of Major Depression: A Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change in Connor-Davidson Resilience Scale Score
Study Overview
Brief Summary
The investigators are doing this research study to find out if the Stress Management and Resiliency Training (SMART) therapy will help subjects with their major depression treatment.
Detailed Description
The investigators propose to conduct an initial feasibility study in a sample of patients in treatment for major depression using SMART. The intervention will be weekly group therapy session of SMART for 8 weeks duration. Once enrolled, participants will complete a Structured Clinical Interview for Diagnosis (SCID). The SCID will primarily serve to confirm a diagnosis of Major Depressive Disorder. Each study intervention group (3-4 groups) will be composed of 6-8 research participants per group. There will be no comparison group. The investigators aim to assess adherence with goal of 75% completion of the 8 sessions of SMART and of the homework assignments. Resilience will be measured with the Connor-Davidson resilience scale. Secondary outcomes will include subjective and objective clinical rating scales for major depression.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Attending the Mayo Clinic Depression Center and Behavioral Health Clinic at Mayo Clinic Health System, Austin, Minnesota
- •DSM-V diagnostic confirmation of major depressive disorder (MDD)
- •Baseline PHQ-9 scores in the range of ≥6-≤19, and HAMD-17 score 8-18, or QIDS-C16 score of 6-20
- •Able to speak English
- •Participants will continue taking any prescribed medications from their clinical treatment team
- •Patients with co-morbid secondary diagnoses of persistent depressive disorder and generalized anxiety disorders will be included in the study.
Exclusion Criteria
- •Participants with bipolar disorder
- •Active psychosis
- •Active suicidal ideations
- •Active substance abuse meeting criteria for substance use disorders except nicotine
- •Obsessive compulsive disorder
- •Active Panic disorder with agoraphobia, other phobic disorder
- •Active Posttraumatic stress disorder
- •Active Severe personality disorders.
Arms & Interventions
Depressed Subjects
Subjects will undergo an 8 week behavioral program with Stress Management and Resiliency Training.
Intervention: Stress Management and Resiliency Training (Behavioral)
Outcomes
Primary Outcomes
Change in Connor-Davidson Resilience Scale Score
Time Frame: baseline, 8 weeks
The Connor-Davidson Resilience Scale (CD-RISC), a 25-item scale, was developed to measure resiliency. CD-RISC has been evaluated and has been found to have good internal consistency (α = .89), test-retest reliability (intraclass correlation coefficient = .87), and positive correlation with multiple related measures with ability to distinguish between participants with lesser and greater resilience. The scores can range from 0 to 100. The mean score in a general population sample was 80.7 and in psychiatric outpatients 68. A positive change with increasing scores will indicate improvement in resilience.
Secondary Outcomes
- Change in Hamilton Rating Scale for Depression Score(baseline, 8 weeks)
- Change in Patient Health Questionnaire-9 Score(baseline, 8 weeks)
- Change in Quick Inventory of Depressive Symptoms Score(baseline, 8 weeks)
- Change in Generalized Anxiety Disorder-7 Score(baseline, 8 weeks)
- Change in Perceived Stress Scale Score(baseline, 8 weeks)
Investigators
Ashok Seshadri
Consultant, Instructor in Psychiatry
Mayo Clinic