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Completed

NCT Number: NCT04388748

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

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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Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Health System in Albert Lea, Albert Lea, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

6 SMART-D group therapy sessions over 8 weeks

Primary outcomes

  1. Change in patient health questionnaire depression assessment

    Time frame: 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

    Time frame: 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 outcomes

  1. Change in measures of resilience

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 14, 2020
Registry last updated
Jun 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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