Clinical trial NCT03275961: Stress Management and Resiliency Training (SMART) Integrated Into Treatment of Major Depression
Official title: Stress Management and Resiliency Training (SMART) Integrated Into Comprehensive Treatment of Major Depression: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Connor-Davidson Resilience Scale Score
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Change in Hamilton Rating Scale for Depression Score
timeFrame: baseline, 8 weeks
measure: Change in Patient Health Questionnaire-9 Score
timeFrame: baseline, 8 weeks
measure: Change in Quick Inventory of Depressive Symptoms Score
timeFrame: baseline, 8 weeks
measure: Change in Generalized Anxiety Disorder-7 Score
timeFrame: baseline, 8 weeks
measure: Change in Perceived Stress Scale Score
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ashok Seshadri, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.