Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
NCT Number: NCT01383811
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hershey, Pennsylvania, 17033, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Exercise, Aerobic Exercise
The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before.
Other names: Usual care, Care as usual, Standard Care
Time frame: 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.
Time frame: Baseline, 6 weeks, and 12 weeks
Time frame: Baseline, 6 weeks, 12 weeks
This is a widely used reliable and standardized measure of depression.
Time frame: baseline, 6 weeks, 12 weeks.
PSQI is a widely used, reliable and standardized measure of subjecitve sleep
Milton S. Hershey Medical Center
Other
Clinical and Neuroendocrine/Metabolic Benefits of Exercise in Treatment Resistant Depression (TRD): A Feasibility Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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