Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults with Depressive Symptoms

Not Applicable

Active, not recruiting

• Conditions: Physical Inactivity

• Registration Number: NCT05407935
• Lead Sponsor: Brown University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-06-03
• Study First Posted: 2022-06-07
• Study Start: 2022-08-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Accelerometry	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 Outcome Measures

Name	Time	Method
Change in Self-report physical activity (Godin)	Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months	Self-reported minutes of leisure time physical activity per week weighted by intensity
Change in Self-reported depression symptoms (CES-D)	Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months	Score on the Center for Epidemiological Studies Depression Scale (CES-D)

Trial Locations

Locations (1)

Brown University; 🇺🇸 Providence, Rhode Island, United States