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

Primary Purpose

Physical Inactivity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACTivity
Relaxercise
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Inactivity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brown UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACTivity

Relaxercise

Arm Description

Acceptance and Commitment Therapy for physical activity promotion 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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Self-report physical activity (Godin)
Self-reported minutes of leisure time physical activity per week weighted by intensity
Change in Self-reported depression symptoms (CES-D)
Score on the Center for Epidemiological Studies Depression Scale (CES-D)

Full Information

First Posted
May 31, 2022
Last Updated
July 18, 2022
Sponsor
Brown University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05407935
Brief Title
Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms
Official Title
Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Inactivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACTivity
Arm Type
Experimental
Arm Description
Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
Arm Title
Relaxercise
Arm Type
Active Comparator
Arm Description
Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
Intervention Type
Behavioral
Intervention Name(s)
ACTivity
Intervention Description
Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
Intervention Type
Behavioral
Intervention Name(s)
Relaxercise
Intervention Description
Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
Primary Outcome Measure Information:
Title
Change in Accelerometry
Description
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.
Time Frame
Baseline, Post-Treatment (8 weeks), 6-months
Secondary Outcome Measure Information:
Title
Change in Self-report physical activity (Godin)
Description
Self-reported minutes of leisure time physical activity per week weighted by intensity
Time Frame
Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
Title
Change in Self-reported depression symptoms (CES-D)
Description
Score on the Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame
Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
Other Pre-specified Outcome Measures:
Title
Change in Physical activity values clarification (valuing questionnaire)
Description
Measures how a person's values align with physical activity
Time Frame
Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
Title
Change in Acceptance of physical activity-related distress (Physical Activity Acceptance Questionnaire)
Description
Measures the extent to which a person can tolerate any distress associated with physical activity
Time Frame
Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
Title
Change in Physical activity-related motivation (Treatment Self-Regulation Questionnaire - Exercise Version)
Description
Measures the extent to which a person is motivated to engage in physical activity
Time Frame
Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
Title
Change in Discomfort intolerance (Discomfort Intolerance Scale)
Description
Measures the extent to which a person can tolerate uncomfortable experiences
Time Frame
Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
Title
Change in Physical activity enjoyment (PACES questionnaire)
Description
Measures the extent to which a person enjoys physical activity
Time Frame
Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
Title
Change in Credibility and expectancy questionnaire
Description
Measures perceived credibility and expected benefits of treatment
Time Frame
Week 1 (After the first treatment session)
Title
Change in Client satisfaction questionnaire
Description
Measures satisfaction with treatment
Time Frame
Post-Treatment (8 weeks) and following the booster session (12 weeks)
Title
Change in Group cohesion questionnaire
Description
Measures perceived cohesiveness of the treatment group
Time Frame
Post-Treatment (8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren C Bohlen, Ph.D.
Phone
401-863-6559
Email
lauren_bohlen@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Da M Wil, Ph.D.
Organizational Affiliation
Brown University School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Connell Bohlen, PhD
Phone
401-863-6559
Email
lauren_bohlen@brown.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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