Randomized Controlled Trial of Stress Management and Resiliency Training for Depression (SMART-D) vs Treatment as Usual in the Treatment of Major Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 27
- Locations
- 6
- Primary Endpoint
- Change in severity of depression
Study Overview
Brief Summary
Researchers are trying to find out if a Stress Management and Resiliency Training (SMART-D) therapy will help with major depression treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants will be enrolled for this study from patients attending the Mayo Clinic Depression Center, Mayo Clinic Family Medicine clinics, Behavioral Health and Primary Care Clinic at Mayo Clinic Health System, Austin, MN, with a diagnosis of major depression, in partial or near remission with PHQ-9 scores ≤14
- •Participants will be required to be between 25 and 80 years old
- •Able to speak English
- •Able to provide written informed consent to participate in the study
- •Participants must have DSM-V diagnostic confirmation of major depressive disorder (MDD) (American Psychiatric Association 2013).
- •Participants will continue taking any prescribed medications from their clinical treatment team.
- •Participants with co-morbid secondary diagnoses of persistent depressive disorder and generalized anxiety disorders will be included in the study.
- •Participants must consent to audio recording of random group sessions which will be disclosed at the final study session.
Exclusion Criteria
- •Participants with bipolar disorder, active psychosis, active suicidal ideations, and active substance abuse meeting criteria for substance use disorders except nicotine, obsessive compulsive disorder, active panic disorder with agoraphobia or other phobic disorder, active posttraumatic stress disorder, active severe personality disorders will be excluded.
- •Pregnant women - because of time duration of the study.
Outcomes
Primary Outcomes
Change in severity of depression
Time Frame: Baseline, week 1, week 8, 3 months, 6 months
Measured using the 17 item Hamilton Depression Rating scale (HAM-D) where total scores are reported on a scale of 0 - 7 = Normal, 8 - 13 = Mild Depression, 14-18 = Moderate Depression, 19 - 22 = Severe Depression, \> 23 = Very Severe Depression
Change in patient health questionnaire depression assessment
Time Frame: Baseline, week 1, week 8, 3 months, 6 months
Measured using the patient health questionnaire (PHQ-9) where total scores are reported on a scale of 1-4 Minimal depression, 5-9 Mild depression, 10-14 Moderate depression, 15-19 Moderately severe depression, 20-27 Severe depression
Secondary Outcomes
- Changed in perceived stress scale(1 week, 8 week, 3 month, 6 month)
- Change in measures of resilience(1 week, 8 week, 3 month, 6 month)
Investigators
Ashok Seshadri
Principal Investigator
Mayo Clinic