Stress Management and Resiliency Training (SMART) Integrated Into Treatment of Major Depression

NCT ID: NCT03275961

Last Updated: 2018-11-14

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-29

Study Completion Date

2018-10-15

Brief Summary

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The investigators are doing this research study to find out if the Stress Management and Resiliency Training (SMART) therapy will help subjects with their major depression treatment.

Detailed Description

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The investigators propose to conduct an initial feasibility study in a sample of patients in treatment for major depression using SMART. The intervention will be weekly group therapy session of SMART for 8 weeks duration. Once enrolled, participants will complete a Structured Clinical Interview for Diagnosis (SCID). The SCID will primarily serve to confirm a diagnosis of Major Depressive Disorder. Each study intervention group (3-4 groups) will be composed of 6-8 research participants per group. There will be no comparison group. The investigators aim to assess adherence with goal of 75% completion of the 8 sessions of SMART and of the homework assignments. Resilience will be measured with the Connor-Davidson resilience scale. Secondary outcomes will include subjective and objective clinical rating scales for major depression.

Conditions

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Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Depressed Subjects

Subjects will undergo an 8 week behavioral program with Stress Management and Resiliency Training.

Group Type EXPERIMENTAL

Stress Management and Resiliency Training

Intervention Type BEHAVIORAL

Subjects will undergo an 8 week behavioral program. Treatment will consist of weekly group therapy sessions in small groups with core practices to apply the principles of SMART.

Interventions

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Stress Management and Resiliency Training

Subjects will undergo an 8 week behavioral program. Treatment will consist of weekly group therapy sessions in small groups with core practices to apply the principles of SMART.

Intervention Type BEHAVIORAL

Other Intervention Names

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SMART

Eligibility Criteria

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Inclusion Criteria

* Attending the Mayo Clinic Depression Center and Behavioral Health Clinic at Mayo Clinic Health System, Austin, Minnesota
* DSM-V diagnostic confirmation of major depressive disorder (MDD)
* Baseline PHQ-9 scores in the range of ≥6-≤19, and HAMD-17 score 8-18, or QIDS-C16 score of 6-20
* Able to speak English
* Participants will continue taking any prescribed medications from their clinical treatment team
* Patients with co-morbid secondary diagnoses of persistent depressive disorder and generalized anxiety disorders will be included in the study.

Exclusion Criteria

* Participants with bipolar disorder
* Active psychosis
* Active suicidal ideations
* Active substance abuse meeting criteria for substance use disorders except nicotine
* Obsessive compulsive disorder
* Active Panic disorder with agoraphobia, other phobic disorder
* Active Posttraumatic stress disorder
* Active Severe personality disorders.
Minimum Eligible Age

18 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

Consultant, Instructor in Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashok Seshadri, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Seshadri A, Clark MM, Kung S, Fuller-Tyszkiewicz M, Sood A, Dammen KC, Rico JA, Tye SJ, McGillivray J, Frye MA. Feasibility Study of Stress Management and Resiliency Training (SMART) in Patients With Major Depressive Disorder. Prim Care Companion CNS Disord. 2020 Apr 30;22(3):19m02556. doi: 10.4088/PCC.19m02556.

Reference Type DERIVED
PMID: 32369689 (View on PubMed)

Other Identifiers

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16-007944

Identifier Type: -

Identifier Source: org_study_id

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