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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02781688
Other study ID # STU 092015-038
Secondary ID
Status Completed
Phase N/A
First received May 3, 2016
Last updated October 26, 2017
Start date January 2016
Est. completion date August 2017

Study information

Verified date October 2017
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pilot study to assess a multi-component intervention to increase physical activity in persons with depression.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date August 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.).

Locations

Country Name City State
United States UT Southwestern Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 weeks
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