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

Mayo Clinic

Status: Completed

Conditions: Depression

Treatments: Behavioral: Stress Management and Resiliency Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03275961

16-007944

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Depressed Subjects

Experimental group

Description:

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

Treatment:

Behavioral: Stress Management and Resiliency Training