Increasing Physical Activity in Persons… | Clinical Trial

Key information

Conditions

Depression Behavior Behavioral Symptoms Motor Activity Physical Activity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Increasing Physical Activity in Persons With Depression - Pilot

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: May 24, 2016
Registry last updated: Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed