Stress Management and Resiliency Training for Depression vs Treatment as Usual in the Treatment of Major Depression
- Conditions
- Major Depression
- Interventions
- Behavioral: Stress Management and Resiliency Training for Depression (SMART-D) Therapy
- Registration Number
- NCT04388748
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Researchers are trying to find out if a Stress Management and Resiliency Training (SMART-D) therapy will help with major depression treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SMART-D Intervention Group Stress Management and Resiliency Training for Depression (SMART-D) Therapy Subjects will participate in Stress Management and Resiliency Training for Depression (SMART-D) therapy as well as treatment as usual which consists of any ongoing medication or psychotherapy based treatments that are currently in place.
- Primary Outcome Measures
Name Time Method Change in severity of depression 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 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 Outcome Measures
Name Time Method Changed in perceived stress scale 1 week, 8 week, 3 month, 6 month Measured using Perceived Stress Scale (PSS). Subjects are asked to answer a 10 question about their feelings and thoughts during the last month using a scale of 0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often
Change in measures of resilience 1 week, 8 week, 3 month, 6 month Measured using the Connor Davidson Resiliency Scale. Subjects are asked to indicate if they agree with 25 statements on a scale of 0=not true at all, 1=rarely true, 2=sometimes true, 3=often true and 4=true nearly all the time
Trial Locations
- Locations (3)
Mayo Clinic Health System in Austin
🇺🇸Austin, Minnesota, United States
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Mayo Clinic Health System in Albert Lea
🇺🇸Albert Lea, Minnesota, United States