Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Physical Inactivity
- Sponsor
- Brown University
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Change in Accelerometry
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
The goal of the proposed project is to conduct a feasibility clinical trial comparing group-based acceptance and commitment therapy for physical activity, (ACT; ACTivity) to a time- and attention-matched standard PA intervention (i.e., PA education, goal-setting, and self-monitoring) plus relaxation training comparison condition (Relaxercise) among 60 low-active adults (ages 18-65) with elevated depressive symptoms. Participants will be randomized to treatment condition, followed for 6 months, including the 8-week treatment. Participants will be randomized 1:1 to treatment condition, followed for 6 months, including the 8-week treatment, and receive a 6-month YMCA membership to equate access to PA facilities.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Elevated depressive symptoms (CES-D score of greater than or equal to 10)
- •Low-active (less than 60 minutes per week of moderate intensity PA)
- •Willing and able to attend weekly virtual video sessions via Zoom
Exclusion Criteria
- •Regular mindfulness meditation practice (more than once per week)
- •Body Mass Index (BMI) less than 18.5 or greater than 40
- •History or presence of any condition that may limit or substantially increase the risks of physical activity
- •Active suicidal thoughts or behaviors
- •Currently participating in any exercise or weight-loss research studies
- •Household member is participating in this study
- •Does not have a Rhode Island mailing address OR if only Rhode Island mailing address is a PO box
- •Unable to receive materials in the mail at residential mailing address
- •Does not plan to live in Rhode Island for the next 6 months
- •Unable to speak, read, and/or write fluently in English
Outcomes
Primary Outcomes
Change in Accelerometry
Time Frame: Baseline, Post-Treatment (8 weeks), 6-months
Minutes of physical activity weighted by intensity, expressed in metabolic equivalent (MET) minutes per week as determined by accelerometers (Actigraph \[model wGT3x-BT\]) worn during one-week periods.
Secondary Outcomes
- Change in Self-report physical activity (Godin)(Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months)
- Change in Self-reported depression symptoms (CES-D)(Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months)