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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04388748
• Collaborator: (none)
• Enrollment: 80
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 24.4
• Patients Per Site: 26.7
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

Researchers are trying to find out if a Stress Management and Resiliency Training (SMART-D) therapy will help with major depression treatment.

Condition or Disease	Intervention/Treatment	Phase
Major Depression	Behavioral: Stress Management and Resiliency Training for Depression (SMART-D) Therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Dec 18, 2020
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SMART-D Intervention Group 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; 6 SMART-D group therapy sessions over 8 weeks
No Intervention: Standard of Care Group Treatment as usual will consist of any ongoing medication or psychotherapy based treatments that are currently in place.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Secondary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Health System in Albert Lea	Albert Lea	Minnesota	United States	56007
2	Mayo Clinic Health System in Austin	Austin	Minnesota	United States	55912
3	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Ashok Seshadri, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Ashok Seshadri, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04388748
• Other Study ID Numbers: 19-009475
• First Posted: May 14, 2020
• Last Update Posted: Feb 11, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major

Study Results

No Results Posted as of Feb 11, 2022