A Health Intervention to Prevent Depression Hepatitis C Patients

Study Overview
=================
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.

Official Title
-----------------
An Exercise Intervention to Prevent Interferon-Induced Depression in Hepatitis C

Conditions
-----------------
Hepatitis C, Major Depressive Disorder

Intervention / Treatment
-----------------
* Behavioral: Exercise
* Behavioral: Health Education


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Health Education<br>Participants will three attend heath education sessions per week for 26 weeks. | Behavioral: Health Education<br> <br> |
| Experimental: Exercise<br>Participants will engage in a public health dose of moderate-to-vigorous aerobic exercise for 26 weeks. | Behavioral: Exercise<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depressive Symptoms over 6 months |  | Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep Quality over 6 months |  | Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27 | 
| Change in blood biomarkers over 6 months |  | Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Interferon-alpha, Depression, Major Depressive Disorder, Exercise, Physical Activity