Exercise in Treatment Resistant Depression (TRD): A Feasibility Study
- Conditions
- Treatment Resistant Depression
- Interventions
- Other: Moderate Intensity Aerobic ExerciseOther: Wait-list
- Registration Number
- NCT01383811
- Lead Sponsor
- Milton S. Hershey Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- Being sedentary (exercising less than 3 times/week for > 20 minutes at moderate/vigorous intensity for each bout)
- Ability to come for supervised exercises up to 5 days/week.
- On stable doses of medication or psychotherapy (within last 1 month) for underlying depression and willingness to continue on stable dose or therapy schedule during active phase of study participation, with the exception of during acute exacerbation of symptoms of psychiatric illness.
- Being able to read, understand, and provide written informed consent.
- DSM-IV TR Axis I diagnosis of bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance or alcohol abuse/dependence disorder (except nicotine dependence) in the past 12 months. Patients with current primary anxiety disorder will also be excluded.
- Behavioral or personality disturbances, which may significantly interfere with study participation.
- Evidence of acute suicidal risk.
- Medical contraindication for physical exercise (significant orthopedic or cardiopulmonary disorder) that would prevent regular aerobic exercise. The American College of Sports Medicine criteria for risk stratification will be used and where indicated medical clearance for exercise will be obtained through the subject's primary care physician.
- Pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate Intensity Aerobic Exercise Moderate Intensity Aerobic Exercise - Moderate Intensity Aerobic Exercise Wait-list - Wait List/Usual Care Wait-list 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
- Primary Outcome Measures
Name Time Method Change from baseline on Hamilton Rating Scale for Depression-17 item (HRSD17)score Baseline, 6 weeks, and 12 weeks Hamilton Rating Scale for Depression-17 item (HRSD17, a well standardized measure of depression will be the primary measures of efficacy.
- Secondary Outcome Measures
Name Time Method Reduction in baseline scores of clinical global impression severity Baseline, 6 weeks, and 12 weeks Change from baseline on Beck Depression Inventory-II score Baseline, 6 weeks, 12 weeks This is a widely used reliable and standardized measure of depression.
Change from baseline on Pittsburgh Sleep Quality Index (PSQI) global sleep quality score baseline, 6 weeks, 12 weeks. PSQI is a widely used, reliable and standardized measure of subjecitve sleep
Trial Locations
- Locations (1)
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States