Overcoming Neuropsychiatric Barriers to the Treatment of Hepatitis C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Whether or not the patient is deemed an appropriate candidate for interferon therapy at the end of the 9-month intervention.
研究概览
简要总结
The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that will assist patients with hepatitis C in overcoming barriers that prevent them from becoming appropriate candidates for interferon therapy.
详细描述
The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that will assist patients with hepatitis C in overcoming barriers that prevent them from becoming appropriate candidates for interferon therapy. Patients who have been deferred from therapy due to mental health or substance abuse issues will work with the team psychologist on following through with the hepatologist's treatment recommendations that would lead to becoming eligible for interferon therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has confirmed diagnosis of HCV;
- •Patient has expressed an interest in undergoing interferon treatment;
- •Patient is deferred from interferon therapy for psychiatric, alcohol use, or other psychosocial issues;
- •Patient must be completely medically cleared by the hepatologist with no outstanding medical conditions that would deem them ineligible from treatment;
- •Patient must have only psychiatric issues and/or substance use issues; but otherwise no other contraindications for treatment.
排除标准
- •Patient has a diagnosis of schizophrenia, psychosis;
- •Patient resides in a psychiatric residential facility;
- •Patient attempted suicide in the past five years;
- •Patient is a current intravenous drug user;
- •Patient is cognitively or decisionally-impaired due to brain disease or injury;
- •Patient has advanced liver disease that precludes them from interferon treatment;
- •Patient has other medical comorbidities that may exclude them from interferon treatment;
- •Patient does not want to pursue interferon treatment at the present time;
- •Patient has significant financial constraints, such as no insurance or homelessness, that would prevent them acquiring mental health or substance abuse services;
- •No access to telephone service;
- •Non-English speaking.
结局指标
主要结局
Whether or not the patient is deemed an appropriate candidate for interferon therapy at the end of the 9-month intervention.
时间窗: 3-, 6-, and 9-months
次要结局
未报告次要终点
研究者
Donna Evon
Assistant Professor of Medicine
University of North Carolina, Chapel Hill