Stress Management and Resiliency Training (SMART) Integrated Into Treatment of Major Depression
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|ClinicalTrials.gov Identifier: NCT03275961|
Recruitment Status : Active, not recruiting
First Posted : September 8, 2017
Last Update Posted : August 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Stress Management and Resiliency Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stress Management and Resiliency Training (SMART) Integrated Into Comprehensive Treatment of Major Depression: A Feasibility Study|
|Actual Study Start Date :||November 29, 2016|
|Actual Primary Completion Date :||July 1, 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: Depressed Subjects
Subjects will undergo an 8 week behavioral program with Stress Management and Resiliency Training.
Behavioral: Stress Management and Resiliency Training
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.
Other Name: SMART
- Change in Connor-Davidson Resilience Scale Score [ Time Frame: baseline, 8 weeks ]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.
- Change in Hamilton Rating Scale for Depression Score [ Time Frame: baseline, 8 weeks ]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 [ Time Frame: baseline, 8 weeks ]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 [ Time Frame: baseline, 8 weeks ]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 [ Time Frame: baseline, 8 weeks ]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 [ Time Frame: baseline, 8 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275961
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Ashok Seshadri, M.D.||Mayo Clinic|