NCT01890083终止2 期
An Exercise Intervention to Prevent Interferon-Induced Depression in Hepatitis C
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in Depressive Symptoms over 6 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Health Education
Active Comparator
Participants will three attend heath education sessions per week for 26 weeks.
干预措施: Health Education (Behavioral)
Exercise
Experimental
Participants will engage in a public health dose of moderate-to-vigorous aerobic exercise for 26 weeks.
干预措施: Exercise (Behavioral)
结局指标
主要结局
Change in Depressive Symptoms over 6 months
时间窗: Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27
次要结局
- 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)
研究者
研究点 (1)
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