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| Name | Class |
|---|---|
| Penn State University | OTHER |
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The objective of this study is to determine the effects of adjunct exercise in treatment resistant depression. The central hypothesis for the research is that adjunct exercise with usual care in Treatment Resistant Depression (TRD) will have significant effects in improving the psychiatric symptoms in comparison to usual care alone.
Participants with treatment resistant depression will be recruited to participate in a 12-week clinical trial on the effects of adjunct moderate-intensity exercise versus usual care. Primary outcome measure will be reduction in baseline scores on Hamilton Depression Rating Scale (17 item). Secondary outcome measure will include reduction in baseline scores of clinical global impression severity, pittsburgh sleep quality index global score, scores on beck depression inventory, and improvement in actigraphic sleep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Intensity Aerobic Exercise | Active Comparator |
| |
| Wait List/Usual Care | Other | The subjects in this group will continue to receive the usual treatment that they were on at the time of enrollment through the wait list period of 12 weeks. Subsequently they will receive the 12 weeks of aerobic exercise program intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate Intensity Aerobic Exercise | Other | Individuals in this group will receive moderate intensity exercise in addition to their usual care (Medications+/-Psychotherapy). The moderate intensity exercise program will involve gradual progression in exercise intensity and duration. During the first 4 weeks, participants will attend 3 supervised sessions/week and will be asked to complete at least 2 unsupervised aerobic exercise sessions/week. From weeks 5-8 the number of supervised sessions will be 2/week with at least 3 unsupervised aerobic exercise sessions/week. From weeks 9-12, the participants will have only 1 supervised session/week and will be asked to complete at least 4 unsupervised aerobic exercise sessions/week. In total, the participants will be required to complete 150 minutes of moderate physical activity/week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on Hamilton Rating Scale for Depression-17 item (HRSD17)score | Hamilton Rating Scale for Depression-17 item (HRSD17, a well standardized measure of depression will be the primary measures of efficacy. | Baseline, 6 weeks, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in baseline scores of clinical global impression severity | Baseline, 6 weeks, and 12 weeks | |
| Change from baseline on Beck Depression Inventory-II score | This is a widely used reliable and standardized measure of depression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ravi Singareddy, MD | Penn State Univ. College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D014850 | Waiting Lists |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
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| Wait-list | Other | The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before. |
|
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| Baseline, 6 weeks, 12 weeks |
| Change from baseline on Pittsburgh Sleep Quality Index (PSQI) global sleep quality score | PSQI is a widely used, reliable and standardized measure of subjecitve sleep | baseline, 6 weeks, 12 weeks. |
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |