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

NCT04388748 | Completed

• 1 other identifier: 19-009475
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Major Depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in measures of resilience

  1 week, 8 week, 3 month, 6 month

• Changed in perceived stress scale

  1 week, 8 week, 3 month, 6 month

Study Arms (2)

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.

Behavioral: Stress Management and Resiliency Training for Depression (SMART-D) Therapy

Standard of Care Group

NO INTERVENTION

Treatment as usual will consist of any ongoing medication or psychotherapy based treatments that are currently in place.

Interventions

Stress Management and Resiliency Training for Depression (SMART-D) Therapy BEHAVIORAL

6 SMART-D group therapy sessions over 8 weeks

SMART-D Intervention Group

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, 56007, United States

Location

Mayo Clinic Health System in Austin

Austin, Minnesota, 55912, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 40828809 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ashok Seshadri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 14, 2020
• Study Start: December 18, 2020
• Primary Completion: October 24, 2022
• Study Completion: May 25, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)