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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Brown University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Behavioral: ACTivity
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)
Behavioral: Relaxercise
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)
Behavioral: Relaxercise
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)
Behavioral: ACTivity
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brown University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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