Stress Management and Resiliency Training for Depression vs Treatment as Usual in the Treatment of Major 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.

Official Title
-----------------
Randomized Controlled Trial of Stress Management and Resiliency Training for Depression (SMART-D) vs Treatment as Usual in the Treatment of Major Depression

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Behavioral: Stress Management and Resiliency Training for Depression (SMART-D) Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMART-D Intervention Group<br>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. | Behavioral: Stress Management and Resiliency Training for Depression (SMART-D) Therapy<br>* 6 SMART-D group therapy sessions over 8 weeks<br>|
| No Intervention: Standard of Care Group<br>Treatment as usual will consist of any ongoing medication or psychotherapy based treatments that are currently in place. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |