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A Health Intervention to Prevent Depression Hepatitis C Patients

Primary Purpose

Hepatitis C, Major Depressive Disorder

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Exercise

Health Education

About this trial

This is an interventional prevention trial for Hepatitis C focused on measuring Hepatitis C, Interferon-alpha, Depression, Major Depressive Disorder, Exercise, Physical Activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Health Education

Exercise

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Depressive Symptoms over 6 months

Secondary Outcome Measures

Change in Sleep Quality over 6 months

Change in blood biomarkers over 6 months

Full Information

NCT ID

NCT01890083

First Posted

June 5, 2013

Last Updated

December 28, 2016

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01890083

Brief Title

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

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Terminated

Why Stopped

Lack of eligible patients due to introduction of new drugs for Hepatitis C

Study Start Date

June 2013 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Major Depressive Disorder

Keywords

Hepatitis C, Interferon-alpha, Depression, Major Depressive Disorder, Exercise, Physical Activity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Health Education

Arm Type

Active Comparator

Arm Description

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

Arm Title

Exercise

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Type

Behavioral

Intervention Name(s)

Health Education

Primary Outcome Measure Information:

Title

Change in Depressive Symptoms over 6 months

Time Frame

Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27

Secondary Outcome Measure Information:

Title

Change in Sleep Quality over 6 months

Time Frame

Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27

Title

Change in blood biomarkers over 6 months

Time Frame

Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chad D Rethorst, Ph.D.

Organizational Affiliation

UT Southwestern Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9119

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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A Health Intervention to Prevent Depression Hepatitis C Patients

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