A Health Intervention to Prevent Depression Hepatitis C Patients
| Status: | Terminated |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD), Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/30/2016 |
| Start Date: | June 2013 |
| End Date: | October 2015 |
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.
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.
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
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