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

NCT ID: NCT04388748

Last Updated: 2023-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-18

Study Completion Date

2023-05-25

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

6 SMART-D group therapy sessions over 8 weeks

Standard of Care Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

6 SMART-D group therapy sessions over 8 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ashok Seshadri

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashok Seshadri, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States

Site Status

Mayo Clinic Health System in Austin

Austin, Minnesota, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40828809 (View on PubMed)

Related Links

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Other Identifiers

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19-009475

Identifier Type: -

Identifier Source: org_study_id

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