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Completed

NCT Number: NCT05407935

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

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.

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Key information

Conditions

Physical Inactivity Behavior Sedentary Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown University

Providence, Rhode Island, 02912, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activity

Behavioral

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

Relaxercise

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

Other outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  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)

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2022
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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