Clinical trial NCT01890083: A Health Intervention to Prevent Depression Hepatitis C Patients
Official title: An Exercise Intervention to Prevent Interferon-Induced Depression in Hepatitis C
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Hepatitis C
Major Depressive Disorder
Keywords: Hepatitis C
Interferon-alpha
Depression
Major Depressive Disorder
Exercise
Physical Activity
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Interferon-alpha (IFN-α) is an efficacious treatment for Hepatitis C (HPC); however, IFN-α treatment results in a significant increase in depressive symptoms. The aim of this project is to compare two health interventions (exercise vs. health education) to prevent depression in HPC patients receiving IFN-α. Participants will be recruited from the Clinical Center for Liver Diseases at UT-Southwestern and randomized to 26 weeks of either: aerobic exercise or a health education control group.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Hepatitis C and prescribed IFN-α
* 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:

* Have a medical condition contraindicating exercise participation
* 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

Primary outcomes:
measure: Change in Depressive Symptoms over 6 months
timeFrame: Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27
Secondary outcomes:
measure: Change in Sleep Quality over 6 months
timeFrame: Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27
measure: Change in blood biomarkers over 6 months
timeFrame: Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Chad D Rethorst, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: