A Health Intervention to Prevent Depression Hepatitis C Patients

December 28, 2016 updated by: University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390-9119
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Chad D Rethorst, Ph.D., UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

June 5, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (Estimate)

July 1, 2013

Study Record Updates

Last Update Posted (Estimate)

December 29, 2016

Last Update Submitted That Met QC Criteria

December 28, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K01MH097847 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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