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Increasing Physical Activity in Persons With Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781688
First Posted: May 24, 2016
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
  Purpose
Pilot study to assess a multi-component intervention to increase physical activity in persons with depression.

Condition Intervention
Depression Physical Activity Behavioral: Physical Activity

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Increasing Physical Activity in Persons With Depression - Pilot

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Moderate-to-vigorous physical activity as measured by Actigraph accelerometer [ Time Frame: 12 weeks ]
    Assess changes in minutes of moderate-to-vigorous physical activity (MVPA) at 3 months following physical activity intervention.


Enrollment: 25
Actual Study Start Date: January 2016
Study Completion Date: August 2017
Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical Activity Intervention
Participants will participate in a multi-component physical activity intervention for 12 weeks.
Behavioral: Physical Activity

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.).


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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781688


Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
  More Information

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02781688     History of Changes
Other Study ID Numbers: STU 092015-038
First Submitted: May 3, 2016
First Posted: May 24, 2016
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders