Increasing Physical Activity in Persons With Depression

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02781688

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Depression Physical Activity	Behavioral: Physical Activity	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Increasing Physical Activity in Persons With Depression - Pilot

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.).

Arm

Intervention/Treatment

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.).

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	UT Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT02781688

Other Study ID Numbers:

STU 092015-038

First Posted:

May 24, 2016

Last Update Posted:

Oct 30, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Oct 30, 2017