Initiating and Maintaining Physical Activity in Depressed Individuals (Project MOVE)
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BA (brief advice)
SHE (supervised and home-based exercise)
HE (health education)
CBEX (cognitive-behavioral sessions focused on increasing and maintaining exercise)
Sponsored by

About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria:
- Sedentary, i.e., have not participated regularly in moderate-to-vigorous physical activity (MVPA) for 90 minutes per week or more for more than 6 weeks of the past 12 weeks.
- Medically cleared for MVPA, documented by a note from their primary care provider.
- No significant medical condition or physical disability that would interfere with physical activity or study participation. The investigators will exclude individuals with significant cardiovascular disease, hematologic disorders, and autoimmune disorders. The investigators will also exclude individuals who are planning a surgery in the next 9 months and those with dementia.
- Elevated depression symptoms. To meet criteria for elevated symptoms, participants must have a QIDS score of 8 or greater (i.e., at least moderate depression levels), and must have a score of "1" or greater on at least one of the two core DSM-V depressive symptoms, i.e., sad mood or anhedonia. -
- No current bulimia or anorexia (past 3 months); no MDD with psychotic symptoms (past 6 months); no history of bipolar disorder, schizophrenia, or a chronic psychotic condition; (assessed using the SCID).
- No hazardous drug or alcohol use in the past 6 months, as assessed by: a. no substance abuse treatment in the past 6 months; and b. does not meet criteria for a moderate or severe substance use disorder in the past 6 months.
- Depression is not very severe, i.e., QIDS score is <= 20.
- No suicidality requiring immediate treatment.
- Not pregnant or planning on becoming pregnant in the next year.
- Understands English sufficiently well to consent and complete study assessments.
- Aged 18-65.
- Able to make one of the 2 available exercise class times.
- Able to walk 1 mile
- Weight does not exceed 375 lbs.
- If participants are aged 60 or older, or if there is any concern about their cognitive capacity, participants will undergo a brief cognitive functioning screener, the Montreal Cognitive Assessment (MOCA). Participants are required to achieve a score within 1 SD of the mean for their age and education level to participate in the study.
Sites / Locations
- Butler Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Active Comparator
Experimental
Arm Label
BA
BA + SHE + HE
BA + SHE + CBEX
Arm Description
Brief advice to exercise. This serves as a control condition.
Brief advice to exercise + supervised & home-based exercise + health education
Brief advice to exercise + supervised & home-based exercise + cognitive-behavioral sessions focused on increasing and maintaining exercise
Outcomes
Primary Outcome Measures
Change in minutes of moderate-vigorous physical activity (MVPA) per week assessed via accelerometer
Secondary Outcome Measures
change in depression assessed via Quick Inventory of Depression Symptoms
depression assessed via blind evaluator using the Quick Inventory of Depression Symptoms (QIDS)
change in cardiorespiratory fitness
change in self-report of MVPA assessed via International physical activity questionnaire
change in Self-report of pain assessed via the SF-36
change in Self-report of overall health assessed via the SF-36
change in Self-report of physical functioning assessed via the SF-36
number, severity, impairment of adverse events
change in anxiety assessed via state-trait anxiety inventory
change in irritability assessed via Brief irritability test
Full Information
NCT ID
NCT02691845
First Posted
February 18, 2016
Last Updated
December 27, 2022
Sponsor
Butler Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT02691845
Brief Title
Initiating and Maintaining Physical Activity in Depressed Individuals
Acronym
Project MOVE
Official Title
Initiating and Maintaining Physical Activity in Depressed Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
March 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators propose a randomized clinical trial in which 240 depressed individuals are assigned to one of three arms, with each successive arm having an added component that may serve to increase and maintain physical activity:
brief advice (BA) to exercise (control condition);
BA + supervised & home-based exercise (SHE) + health education (HE) contact control; and
BA + SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise (CBEX).
The primary aim is to assess and optimize the safety, feasibility, acceptability of each intervention component, as well as barriers limiting their effectiveness in order to prepare for a larger scale randomized clinical trial.
Detailed Description
The investigators propose a randomized clinical trial in which 240 depressed individuals are assigned to one of three arms, with each successive arm having an added component that may serve to increase and maintain physical activity:
brief advice (BA) to exercise (control condition);
BA + supervised & home-based exercise (SHE)+health education (HE) contact control; and
BA+SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise (CBEX).
There are two phases for participants: intervention phase (3 months), which consists of intensive contact, and the follow-up phase (6 months). BA will consist of one, 45-minute session about public health recommendations, and strategies for getting started. SHE will be a 12-week intervention consisting of 1x/week supervised exercise plus exercise prescriptions for home-based exercise with the goal of gradually achieving the public health recommendation of 150 minutes/week of moderate-to-vigorous physical activity (MVPA), CBEX and HE sessions will be individual, 30-minute, weekly sessions during the intervention phase. CBEX will address barriers to physical activity that are particularly pronounced in depression -i.e., anhedonia, decreased motivation, and decreased energy, as well as poor problem-solving skills. During the follow-up phase, groups who received SHE during the intervention phase will receive brief, monthly phone check-ins from an exercise specialist.
Primary Aims:
To compare the efficacy of the 3 arms for increasing physical activity during the 12-week intervention phase. We hypothesize that BA + SHE + CBEX will be superior to BA + SHE + HE, and that BA + SHE + HE will be superior to BA alone in terms of objectively measured MVPA levels.
To compare the longer-term impact of the three arms on objectively-measured minutes of MVPA at 6- and 9-month follow-ups (i.e., follow-up phase). Hypotheses are the same as for the intervention phase (aim #1).
Secondary Aims:
To assess the impact of proposed intervention combinations on depression, physical health outcomes including cardiorespiratory fitness and body composition, and self-reported MVPA in all phases. Hypotheses mirror those described in our primary aims above.
To determine whether amount of MVPA mediates the association between group assignment and change in depressive symptoms. We hypothesize that amount of MVPA will serve as a mediator.
To examine behavior change theory-based mediators of the association between group assignment and MVPA. Hypothesized mediators include: perceived benefits of exercise, perceived barriers to exercise, exercise self-efficacy, intrinsic motivation to exercise, and identified motivation to exercise.
To examine whether social and environmental barriers to exercise predict exercise maintenance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BA
Arm Type
Other
Arm Description
Brief advice to exercise. This serves as a control condition.
Arm Title
BA + SHE + HE
Arm Type
Active Comparator
Arm Description
Brief advice to exercise + supervised & home-based exercise + health education
Arm Title
BA + SHE + CBEX
Arm Type
Experimental
Arm Description
Brief advice to exercise + supervised & home-based exercise + cognitive-behavioral sessions focused on increasing and maintaining exercise
Intervention Type
Behavioral
Intervention Name(s)
BA (brief advice)
Intervention Type
Behavioral
Intervention Name(s)
SHE (supervised and home-based exercise)
Intervention Type
Behavioral
Intervention Name(s)
HE (health education)
Intervention Type
Behavioral
Intervention Name(s)
CBEX (cognitive-behavioral sessions focused on increasing and maintaining exercise)
Primary Outcome Measure Information:
Title
Change in minutes of moderate-vigorous physical activity (MVPA) per week assessed via accelerometer
Time Frame
from baseline to 3 months, 6 months, 9 months
Secondary Outcome Measure Information:
Title
change in depression assessed via Quick Inventory of Depression Symptoms
Description
depression assessed via blind evaluator using the Quick Inventory of Depression Symptoms (QIDS)
Time Frame
Baseline to 3 months, 6 months, 9 months
Title
change in cardiorespiratory fitness
Time Frame
Baseline to 3 months, 6 months, 9 months
Title
change in self-report of MVPA assessed via International physical activity questionnaire
Time Frame
Baseline to 3 months, 6 months, 9 months
Title
change in Self-report of pain assessed via the SF-36
Time Frame
Baseline to 3 months, 6 months, 9 months
Title
change in Self-report of overall health assessed via the SF-36
Time Frame
Baseline to 3 months, 6 months,9 months
Title
change in Self-report of physical functioning assessed via the SF-36
Time Frame
Baseline to 3 months, 6 months, 9 months
Title
number, severity, impairment of adverse events
Time Frame
3 months, 6 months, 9 months
Title
change in anxiety assessed via state-trait anxiety inventory
Time Frame
Baseline to 3 months, 6 months, 9 months
Title
change in irritability assessed via Brief irritability test
Time Frame
Baseline to 3 months, 6 months, 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sedentary, i.e., have not participated regularly in moderate-to-vigorous physical activity (MVPA) for 90 minutes per week or more for more than 6 weeks of the past 12 weeks.
Medically cleared for MVPA, documented by a note from their primary care provider.
No significant medical condition or physical disability that would interfere with physical activity or study participation. The investigators will exclude individuals with significant cardiovascular disease, hematologic disorders, and autoimmune disorders. The investigators will also exclude individuals who are planning a surgery in the next 9 months and those with dementia.
Elevated depression symptoms. To meet criteria for elevated symptoms, participants must have a QIDS score of 8 or greater (i.e., at least moderate depression levels), and must have a score of "1" or greater on at least one of the two core DSM-V depressive symptoms, i.e., sad mood or anhedonia. -
No current bulimia or anorexia (past 3 months); no MDD with psychotic symptoms (past 6 months); no history of bipolar disorder, schizophrenia, or a chronic psychotic condition; (assessed using the SCID).
No hazardous drug or alcohol use in the past 6 months, as assessed by: a. no substance abuse treatment in the past 6 months; and b. does not meet criteria for a moderate or severe substance use disorder in the past 6 months.
Depression is not very severe, i.e., QIDS score is <= 20.
No suicidality requiring immediate treatment.
Not pregnant or planning on becoming pregnant in the next year.
Understands English sufficiently well to consent and complete study assessments.
Aged 18-65.
Able to make one of the 2 available exercise class times.
Able to walk 1 mile
Weight does not exceed 375 lbs.
If participants are aged 60 or older, or if there is any concern about their cognitive capacity, participants will undergo a brief cognitive functioning screener, the Montreal Cognitive Assessment (MOCA). Participants are required to achieve a score within 1 SD of the mean for their age and education level to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Uebelacker, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Abrantes, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Initiating and Maintaining Physical Activity in Depressed Individuals
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