Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms
August 12, 2026 updated by: Brown University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Brown University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Phase 2 ACTivity Group
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|
Active Comparator: Phase 2 Relaxercise Group
Phase 2 of Relaxation Training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|
Active Comparator: Phase 1 Relaxercise Group
Phase 1 of Relaxation Training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|
Experimental: Phase 1 ACTivity Group
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accelerometry
Time Frame: Baseline; Post-Treatment (week 8); Month 6 (week 26)
|
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 (week 8); Month 6 (week 26)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-report Physical Activity (Godin)
Time Frame: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
|
Self-reported minutes of leisure time physical activity per week weighted by intensity.
|
Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
|
|
Self-reported Depression Symptoms (CES-D)
Time Frame: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
|
Score on the Center for Epidemiological Studies Depression Scale (CES-D): CESD SCORE , 20 items (Range 0 to 60, higher score = higher depressive symptoms)
|
Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity Values Clarification (Progress)
Time Frame: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
|
Measures how a person's values align with physical activity: 5 items (Range 0 to 30, higher score=closer alignment between internal values and actions)
|
Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
|
|
Acceptance of Physical Activity-related Distress (Physical Activity Acceptance Questionnaire)
Time Frame: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
|
Measures the extent to which a person can tolerate any distress associated with physical activity: 10 items (Range 10 to 70, higher score= greater acceptance)
|
Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
|
|
Physical Activity-related Motivation (Treatment Self-Regulation Questionnaire - Exercise Version)
Time Frame: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
|
Measures the extent to which a person is motivated to engage in physical activity: 16 items Range ( -18 to 18, with a higher score=greater autonomous motivation to exercise)
|
Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
|
|
Discomfort Intolerance (Discomfort Intolerance Scale)
Time Frame: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
|
Measures the extent to which a person can tolerate uncomfortable experiences: 5 items (Range 0 to 30, higher score =greater discomfort intolerance)
|
Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
|
|
Physical Activity Enjoyment (PACES Questionnaire)
Time Frame: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
|
Measures the extent to which a person enjoys physical activity: 18 items (Range 18 to 126, higher score = greater PA enjoyment)
|
Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
|
|
Credibility and Expectancy Questionnaire
Time Frame: Start of Treatment (week 1)
|
Measures perceived credibility and expected benefits of treatment CREDIBILITY AND EXPECTANCY (Range 1 to 9, higher score= higher credibility)
|
Start of Treatment (week 1)
|
|
Group Cohesion - Positive Bonds
Time Frame: Mid-Treatment (week 4); Post-Treatment (week 8)
|
Measures perceived cohesiveness of the treatment group: 13 items (Range 13 to 91, higher score = greater perceived positive group bonds)
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Mid-Treatment (week 4); Post-Treatment (week 8)
|
|
Client Satisfaction
Time Frame: Post-Treatment (week 8)
|
Measures satisfaction with treatment: 8 items (frequency and % who at least mostly agree with recommending the program)
|
Post-Treatment (week 8)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Da M Wil, Ph.D., Brown University School of Public Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2022
Primary Completion (Actual)
May 30, 2025
Study Completion (Actual)
May 30, 2025
Study Registration Dates
First Submitted
May 31, 2022
First Submitted That Met QC Criteria
June 3, 2022
First Posted (Actual)
June 7, 2022
Study Record Updates
Last Update Posted (Actual)
September 3, 2026
Last Update Submitted That Met QC Criteria
August 12, 2026
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34AT011302 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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