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

Major Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388748
• Other study ID #: 19-009475
• Status: Completed
• Phase: N/A
• Start date: December 18, 2020
• Est. completion date: May 25, 2023

Study information

• Verified date: June 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 25, 2023
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Behavioral:
• Stress Management and Resiliency Training for Depression (SMART-D) Therapy
6 SMART-D group therapy sessions over 8 weeks

Locations

Country	Name	City	State
United States	Mayo Clinic Health System in Albert Lea	Albert Lea	Minnesota
United States	Mayo Clinic Health System in Austin	Austin	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, week 1, week 8, 3 months, 6 months
Primary	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	Baseline, week 1, week 8, 3 months, 6 months
Secondary	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	1 week, 8 week, 3 month, 6 month
Secondary	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	1 week, 8 week, 3 month, 6 month

External Links

•   Mayo Clinic Clinical Trials