Back to resultsIncreasing Physical Activity in Persons With Depression
Primary Purpose
Depression, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria:
- Age 18-65 years
- Positive depression screen (Patient Health Questionnaire [PHQ-9]) or current antidepressant treatment
- Report <150 minutes of weekly moderate-to-vigorous physical activity (MVPA) on the Exercise Vital Sign (EVS)
- Written and verbal fluency in English
Exclusion Criteria:
- Medical condition contraindicating physical activity participation
- Cognitively unable to give informed consent
- Non-English speaking
Sites / Locations
- UT Southwestern Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physical Activity Intervention
Arm Description
Participants will participate in a multi-component physical activity intervention for 12 weeks.
Outcomes
Primary Outcome Measures
Moderate-to-vigorous physical activity as measured by Actigraph accelerometer
Assess changes in minutes of moderate-to-vigorous physical activity (MVPA) at 3 months following physical activity intervention.
Secondary Outcome Measures
Full Information
NCT ID
NCT02781688
First Posted
May 3, 2016
Last Updated
October 26, 2017
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02781688
Brief Title
Increasing Physical Activity in Persons With Depression
Official Title
Increasing Physical Activity in Persons With Depression - Pilot
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pilot study to assess a multi-component intervention to increase physical activity in persons with depression.
Detailed Description
The research project is a pilot study to assess the effects of a multi-component intervention in increasing physical activity among persons with depression. Individuals meeting inclusion/exclusion criteria will be enrolled in the 12-week intervention. Intervention components will include self-monitoring, Active Living counseling, and facility access. Blood samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample collection will also occur at 2 time points during the intervention (Weeks 7 and 13). Changes in physical activity will be assessed using Fitbits to measure weekly minutes of moderate/vigorous activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Physical Activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Activity Intervention
Arm Type
Experimental
Arm Description
Participants will participate in a multi-component physical activity intervention for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
Self-monitoring: Subjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily.
Active Living counseling: The Active Living counseling program will consists of 12 weekly group educational sessions, facilitated by project interventionists. These sessions will involve discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, social support, and time management.
Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).
Primary Outcome Measure Information:
Title
Moderate-to-vigorous physical activity as measured by Actigraph accelerometer
Description
Assess changes in minutes of moderate-to-vigorous physical activity (MVPA) at 3 months following physical activity intervention.
Time Frame
12 weeks
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:
Age 18-65 years
Positive depression screen (Patient Health Questionnaire [PHQ-9]) or current antidepressant treatment
Report <150 minutes of weekly moderate-to-vigorous physical activity (MVPA) on the Exercise Vital Sign (EVS)
Written and verbal fluency in English
Exclusion Criteria:
Medical condition contraindicating physical activity participation
Cognitively unable to give informed consent
Non-English speaking
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Increasing Physical Activity in Persons With Depression
We'll reach out to this number within 24 hrs