NCT02781688

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

May 3, 2016

Last Update Submit

October 26, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Physical Activity Intervention

EXPERIMENTAL

Participants will participate in a multi-component physical activity intervention for 12 weeks.

Behavioral: Physical Activity

Interventions

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.).

Physical Activity Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Medical condition contraindicating physical activity participation
  • Cognitively unable to give informed consent
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

DepressionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 24, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

October 30, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations