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

NCT03275961 | Completed

• 1 other identifier: 16-007944
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Change in Connor-Davidson Resilience Scale Score

  The Connor-Davidson Resilience Scale (CD-RISC), a 25-item scale, was developed to measure resiliency. CD-RISC has been evaluated and has been found to have good internal consistency (α = .89), test-retest reliability (intraclass correlation coefficient = .87), and positive correlation with multiple related measures with ability to distinguish between participants with lesser and greater resilience. The scores can range from 0 to 100. The mean score in a general population sample was 80.7 and in psychiatric outpatients 68. A positive change with increasing scores will indicate improvement in resilience.

  baseline, 8 weeks

Secondary Outcomes (5)

• Change in Hamilton Rating Scale for Depression Score

  baseline, 8 weeks

• Change in Patient Health Questionnaire-9 Score

  baseline, 8 weeks

• Change in Quick Inventory of Depressive Symptoms Score

  baseline, 8 weeks

• Change in Generalized Anxiety Disorder-7 Score

  baseline, 8 weeks

• Change in Perceived Stress Scale Score

  baseline, 8 weeks

Study Arms (1)

Depressed Subjects

EXPERIMENTAL

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

Behavioral: Stress Management and Resiliency Training

Interventions

Stress Management and Resiliency Training 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.

Also known as: SMART

Depressed Subjects

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 32369689 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Ashok Seshadri, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Instructor in Psychiatry

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 8, 2017
• Study Start: November 29, 2016
• Primary Completion: July 1, 2018
• Study Completion: October 15, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)