Efficacy of an Exercise Intervention to Decrease Depressive Symptoms in Veterans With Hepatitis C

Study Overview
=================
Brief Summary
-----------------
In this study, depressed veterans with hepatitis C will be randomly assigned to the control group or to the exercise intervention group. The exercise intervention is designed to begin slowly for most participants and to progress within each participant's target heart rate range for moderate intensity exercise. The exercise intervention is a 12 week home based walking program. Ideally individuals will walk for 30 minutes, at a moderate intensity, a minimum of three times per week. However, the duration and relative intensity will be tailored for each individual. Central Hypothesis Veterans who receive the exercise intervention will be significantly less symptomatic for depression than veterans in the control group.

Official Title
-----------------
Efficacy of an Exercise Intervention to Decrease Depressive Symptoms in Veterans With Hepatitis C

Conditions
-----------------
Hepatitis C, Depression

Intervention / Treatment
-----------------
* Behavioral: Home-based walking program
* Other: Educational intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, age 18 or older Documentation of positive hepatitis C status as indicated by a detectable HCV viral load by polymerase chain reaction Mild to moderate depressive symptoms as evidenced by a BDI II score of ≥ 14 Able to read and understand English Written/signed informed consent specific to this protocol Being sedentary that is , less than 30 minutes of planned low to moderate intensity exercise 2 days per week Exclusion Criteria: Suicidal ideations Current interferon therapy or planning to begin interferon therapy during the next three months Diagnosis of Bipolar disorder, Schizophrenia, or Post Traumatic Stress Disorder Any medical condition, disorder, or medication that contraindicates participation in a mild to moderate intensity walking program

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Home-based walking program | Behavioral: Home-based walking program<br>* The exercise intervention is a 12 week home-based exercise program. Ideally Individuals will walk for 30 minutes, at a moderate intensity, a minimum of three times per week. However, the duration and relative intensity will be tailored for each individual.<br>|
| Other: 2<br>educational intervention | Other: Educational intervention<br>* Participants in the control group will receive a packet of information regarding hepatitis C<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of symptoms of depression as measured by the Beck Depression Inventory II (BDI-II) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI) |  | 12 weeks | 
| reduce the reported level of chronic pain |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis C, depression, exercise