Physical InactivityNCT05407935
Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms
A study testing ACTivity and Relaxercise in people with Physical Inactivity, run by Brown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- ACTivity and Relaxercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2022to 30 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- ACTivity, Relaxercise
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTivityBehavioural
Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
RelaxerciseBehavioural
Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
| Study group | Role | What they receive |
|---|---|---|
| Phase 2 ACTivity Group | Experimental | Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring) Receives: Behavioral: ACTivity |
| Phase 2 Relaxercise Group | Active comparator | Phase 2 of Relaxation Training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring) Receives: Behavioral: Relaxercise |
| Phase 1 Relaxercise Group | Active comparator | Phase 1 of Relaxation Training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring) Receives: Behavioral: Relaxercise |
| Phase 1 ACTivity Group | Experimental | Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring) Receives: Behavioral: ACTivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; Post-Treatment (week 8); Month 6 (week 26)
Secondary outcomes (2)
Self-report Physical Activity (Godin)
Self-reported minutes of leisure time physical activity per week weighted by intensity.
Measured: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
Self-reported Depression Symptoms (CES-D)
Score on the Center for Epidemiological Studies Depression Scale (CES-D): CESD SCORE , 20 items (Range 0 to 60, higher score = higher depressive symptoms)
Measured: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start16 Aug 2022
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Da M Wil, Ph.D., Principal investigator, Brown University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407935
- Sponsor's protocol ID
- R34AT011302
- Status last verified
- Aug 2025
- First submitted
- 31 May 2022
- Last updated
- 3 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms
- ClinicalTrials.gov ID
- NCT05407935
- Acronym / sponsor ID
- R34AT011302
- Conditions
- Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Posted 3 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 2 ACTivity Group | Experimental | Behavioral: ACTivityPhase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring) |
| Phase 2 Relaxercise Group | Active comparator | Behavioral: RelaxercisePhase 2 of Relaxation Training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring) |
| Phase 1 Relaxercise Group | Active comparator | Behavioral: RelaxercisePhase 1 of Relaxation Training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring) |
| Phase 1 ACTivity Group | Experimental | Behavioral: ACTivityPhase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTivityAcceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring) | Behavioural | Phase 1 ACTivity Group, Phase 2 ACTivity Group |
| RelaxerciseRelaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring) | Behavioural | Phase 1 Relaxercise Group, Phase 2 Relaxercise Group |
Primary outcome
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.
2 secondary outcomes
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 Depression Symptoms (CES-D)
Time frame: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Da M Wil, Ph.D. principal investigator
Brown University School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTivity and Relaxercise in people with Physical Inactivity, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accelerometry (time frame: Baseline; Post-Treatment (week 8); Month 6 (week 26)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.