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

NCT05407935 | Completed DMC

• 1 other identifier: R34AT011302
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Inactivity

Outcome Measures

Primary Outcomes (1)

• Change in Accelerometry

  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.

  Baseline, Post-Treatment (8 weeks), 6-months

Secondary Outcomes (2)

• 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

Other Outcomes (8)

• Change in Physical activity values clarification (valuing questionnaire)

  Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months

• Change in Acceptance of physical activity-related distress (Physical Activity Acceptance Questionnaire)

  Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months

• Change in Physical activity-related motivation (Treatment Self-Regulation Questionnaire - Exercise Version)

  Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months

Study Arms (2)

ACTivity

EXPERIMENTAL

Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)

Behavioral: ACTivity

Relaxercise

ACTIVE COMPARATOR

Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)

Behavioral: Relaxercise

Interventions

ACTivity BEHAVIORAL

Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)

ACTivity

Relaxercise BEHAVIORAL

Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)

Relaxercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Da M Wil, Ph.D.

  Brown University School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 7, 2022
• Study Start: August 16, 2022
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

US (1)