Treatment Resistant Depression
Conditions
Keywords
Treatment Resistant Depression, Exercise
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.
Interventions
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.
OTHERWait-list
The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before.
Sponsors
Penn State University
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed