A Health Intervention to Prevent Depression Hepatitis C Patients
NCT ID: NCT01890083
Last Updated: 2016-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
1 participants
INTERVENTIONAL
2013-06-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Health Education
Participants will three attend heath education sessions per week for 26 weeks.
Health Education
Exercise
Participants will engage in a public health dose of moderate-to-vigorous aerobic exercise for 26 weeks.
Exercise
Interventions
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Exercise
Health Education
Eligibility Criteria
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Inclusion Criteria
* Ability to understand and willingness to provide written informed consent.
* Willing to provide contact information.
* Medical clearance with protocol-defined stress testing (in accordance with American College of Sports Medicine (ACSM) guidelines) from protocol approved medical personnel. Details of guidelines and related testing protocol are provided in the study Manual of Procedures.
* Able to comprehend and communicate in English.
Exclusion Criteria
* Are currently physically active - defined as moderate intensity physical activity on 3 or more days per week for the last month
* Have been diagnosed with current Major Depressive Disorder or are currently receiving antidepressant medication treatment (including SSRIs and SNRIs)
* Currently considered a high suicide risk and/or high risk for being unable to complete the study due to the need for psychiatric hospitalization, suicide attempts or suicidality, significant self-mutilation, or other self-injurious or destructive behavior based on the judgment of the site PI, medical personnel, or designee.
* Pregnancy.
* Current psychotic disorder. Other comorbid psychiatric diagnosis that, in the investigator's judgment, will pose a safety issue or make it difficult for the participant to understand or complete the intervention.
* Anticipated circumstances over the 6-month course of the trial that would render the participant unlikely to complete the study in the judgment of the PI or designee.
* Any reason not listed herein yet, determined by the PI, medical personnel, or designee that constitutes good clinical practice and that would in the opinion of the PI, medical personnel, or designee make participation in the study hazardous.
* Are currently enrolled in another research study, and participation in that study contraindicates participation in the current study
18 Years
65 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Principal Investigators
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Chad D Rethorst, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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