A Health Intervention to Prevent Depression Hepatitis C Patients

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT01890083

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Major Depressive Disorder	Behavioral: Exercise Behavioral: Health Education	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Health Education

Participants will three attend heath education sessions per week for 26 weeks.

Behavioral: Health Education

Experimental: Exercise

Participants will engage in a public health dose of moderate-to-vigorous aerobic exercise for 26 weeks.

Behavioral: Exercise

Outcome Measures

Primary Outcome Measures

Change in Depressive Symptoms over 6 months [Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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