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Researchers are trying to find out if a Stress Management and Resiliency Training (SMART-D) therapy will help with major depression treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMART-D Intervention Group | Experimental | 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. |
|
| Standard of Care Group | No Intervention | Treatment as usual will consist of any ongoing medication or psychotherapy based treatments that are currently in place. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress Management and Resiliency Training for Depression (SMART-D) Therapy | Behavioral | 6 SMART-D group therapy sessions over 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient health questionnaire depression assessment | 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 | Baseline, week 1, week 8, 3 months, 6 months |
| Change in severity of depression | 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 | Baseline, week 1, week 8, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in measures of resilience | 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 | 1 week, 8 week, 3 month, 6 month |
| Changed in perceived stress scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashok Seshadri, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Health System in Albert Lea | Albert Lea | Minnesota | 56007 | United States | ||
| Mayo Clinic Health System in Austin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40828809 | Derived | Seshadri A, Fuller-Tyszkiewicz M, Harper L, Clark MM, Singh B, Chesak S, Kaur AS, McGillivray J, Frye MA. Randomized controlled trial of stress management and resiliency training for depression (SMART-D)-pilot study. PLoS One. 2025 Aug 19;20(8):e0328539. doi: 10.1371/journal.pone.0328539. eCollection 2025. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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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 |
| 1 week, 8 week, 3 month, 6 month |
| Austin |
| Minnesota |
| 55912 |
| United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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