Stress Management and Resiliency Training (SMART) Integrated Into Treatment of Major Depression
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Management and Resiliency Training
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Depressed Subjects
Arm Description
Subjects will undergo an 8 week behavioral program with Stress Management and Resiliency Training.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Hamilton Rating Scale for Depression Score
The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17 score ranges from 0 (not ill) to 52 (severely ill). A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms.
Change in Patient Health Questionnaire-9 Score
The Patient Health Questionnaire (PHQ) is a self-administered 9-item scale which scores each of the 9 DSM-V criteria as "0" (not at all) to "3" (nearly every day). PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 6-10,11-15, 16-20, and >20 represented mild, moderate, moderately severe, and severe depression, respectively.
Change in Quick Inventory of Depressive Symptoms Score
The 16-item Quick Inventory of Depressive Symptomatology (QIDS) designed to assess the severity of depressive symptoms. The QIDS assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) to diagnose a major depressive episode. The scores can range from 0 to 27, with 0 being no depression to 27 being very severe depression. Increasing scores indicate worsening depression and decreasing scores indicate improving depression.
Change in Generalized Anxiety Disorder-7 Score
Generalized Anxiety Disorder 7 (GAD-7) is a 7 item self-report scale which scores the symptoms of generalized anxiety disorder (GAD) from "0"( not at all) to "3"( nearly every day). Cut points of 5, 10, and 15 represent mild, moderate, and severe levels of anxiety on the GAD-7.
Change in Perceived Stress Scale Score
The Perceived Stress Scale is a 10 item self-administered scale that measures the degree to which one's life are appraised as stressful. The scores can range from 0( no stress) to 40( very high stress). Scores between 0-13 are considered low stress, 14-26- moderate stress and 27-40- high stress. A decreasing trend of scores would indicate improvement in perceived stress levels.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03275961
Brief Title
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
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 29, 2016 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
October 15, 2018 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Depressed Subjects
Arm Type
Experimental
Arm Description
Subjects will undergo an 8 week behavioral program with Stress Management and Resiliency Training.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management and Resiliency Training
Other Intervention Name(s)
SMART
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Connor-Davidson Resilience Scale Score
Description
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.
Time Frame
baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change in Hamilton Rating Scale for Depression Score
Description
The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17 score ranges from 0 (not ill) to 52 (severely ill). A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms.
Time Frame
baseline, 8 weeks
Title
Change in Patient Health Questionnaire-9 Score
Description
The Patient Health Questionnaire (PHQ) is a self-administered 9-item scale which scores each of the 9 DSM-V criteria as "0" (not at all) to "3" (nearly every day). PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 6-10,11-15, 16-20, and >20 represented mild, moderate, moderately severe, and severe depression, respectively.
Time Frame
baseline, 8 weeks
Title
Change in Quick Inventory of Depressive Symptoms Score
Description
The 16-item Quick Inventory of Depressive Symptomatology (QIDS) designed to assess the severity of depressive symptoms. The QIDS assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) to diagnose a major depressive episode. The scores can range from 0 to 27, with 0 being no depression to 27 being very severe depression. Increasing scores indicate worsening depression and decreasing scores indicate improving depression.
Time Frame
baseline, 8 weeks
Title
Change in Generalized Anxiety Disorder-7 Score
Description
Generalized Anxiety Disorder 7 (GAD-7) is a 7 item self-report scale which scores the symptoms of generalized anxiety disorder (GAD) from "0"( not at all) to "3"( nearly every day). Cut points of 5, 10, and 15 represent mild, moderate, and severe levels of anxiety on the GAD-7.
Time Frame
baseline, 8 weeks
Title
Change in Perceived Stress Scale Score
Description
The Perceived Stress Scale is a 10 item self-administered scale that measures the degree to which one's life are appraised as stressful. The scores can range from 0( no stress) to 40( very high stress). Scores between 0-13 are considered low stress, 14-26- moderate stress and 27-40- high stress. A decreasing trend of scores would indicate improvement in perceived stress levels.
Time Frame
baseline, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashok Seshadri, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32369689
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.
Results Reference
derived
Learn more about this trial
Stress Management and Resiliency Training (SMART) Integrated Into Treatment of Major Depression
We'll reach out to this number within 24 hrs