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

Primary Purpose

Major Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Management and Resiliency Training for Depression (SMART-D) Therapy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Major Depression

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic Health System in Albert Lea
  • Mayo Clinic Health System in Austin
  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SMART-D Intervention Group

Standard of Care Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in patient health questionnaire depression assessment
Measured using the patient health questionnaire (PHQ-9) where total scores are reported on a scale of 1-4 Minimal depression, 5-9 Mild depression, 10-14 Moderate depression, 15-19 Moderately severe depression, 20-27 Severe depression
Change in severity of depression
Measured using the 17 item Hamilton Depression Rating scale (HAM-D) where total scores are reported on a scale of 0 - 7 = Normal, 8 - 13 = Mild Depression, 14-18 = Moderate Depression, 19 - 22 = Severe Depression, > 23 = Very Severe Depression

Secondary Outcome Measures

Change in measures of resilience
Measured using the Connor Davidson Resiliency Scale. Subjects are asked to indicate if they agree with 25 statements on a scale of 0=not true at all, 1=rarely true, 2=sometimes true, 3=often true and 4=true nearly all the time
Changed in perceived stress scale
Measured using Perceived Stress Scale (PSS). Subjects are asked to answer a 10 question about their feelings and thoughts during the last month using a scale of 0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often

Full Information

First Posted
May 12, 2020
Last Updated
June 21, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04388748
Brief Title
Stress Management and Resiliency Training for Depression vs Treatment as Usual in the Treatment of Major Depression
Official Title
Randomized Controlled Trial of Stress Management and Resiliency Training for Depression (SMART-D) vs Treatment as Usual in the Treatment of Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
October 24, 2022 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Researchers are trying to find out if a Stress Management and Resiliency Training (SMART-D) therapy will help with major depression treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMART-D Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care Group
Arm Type
No Intervention
Arm Description
Treatment as usual will consist of any ongoing medication or psychotherapy based treatments that are currently in place.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management and Resiliency Training for Depression (SMART-D) Therapy
Intervention Description
6 SMART-D group therapy sessions over 8 weeks
Primary Outcome Measure Information:
Title
Change in patient health questionnaire depression assessment
Description
Measured using the patient health questionnaire (PHQ-9) where total scores are reported on a scale of 1-4 Minimal depression, 5-9 Mild depression, 10-14 Moderate depression, 15-19 Moderately severe depression, 20-27 Severe depression
Time Frame
Baseline, week 1, week 8, 3 months, 6 months
Title
Change in severity of depression
Description
Measured using the 17 item Hamilton Depression Rating scale (HAM-D) where total scores are reported on a scale of 0 - 7 = Normal, 8 - 13 = Mild Depression, 14-18 = Moderate Depression, 19 - 22 = Severe Depression, > 23 = Very Severe Depression
Time Frame
Baseline, week 1, week 8, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Change in measures of resilience
Description
Measured using the Connor Davidson Resiliency Scale. Subjects are asked to indicate if they agree with 25 statements on a scale of 0=not true at all, 1=rarely true, 2=sometimes true, 3=often true and 4=true nearly all the time
Time Frame
1 week, 8 week, 3 month, 6 month
Title
Changed in perceived stress scale
Description
Measured using Perceived Stress Scale (PSS). Subjects are asked to answer a 10 question about their feelings and thoughts during the last month using a scale of 0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often
Time Frame
1 week, 8 week, 3 month, 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashok Seshadri, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Health System in Albert Lea
City
Albert Lea
State/Province
Minnesota
ZIP/Postal Code
56007
Country
United States
Facility Name
Mayo Clinic Health System in Austin
City
Austin
State/Province
Minnesota
ZIP/Postal Code
55912
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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