Abstract
We propose to evaluate the feasibility of using Mindfulness-Based Cognitive Therapy (MBCT), as a pre-treatment intervention intended to limit patient and family morbidity caused by the known neuropsychiatric side effects of antiviral therapy for chronic hepatitis C infection. The goal of this study is to improve outcomes in the treatment of hepatitis C by supporting the ability of patients to adhere to interferon/ribavirin therapy. Findings from this study will give us a preliminary understanding of whether MBCT, which has been proven effective in randomized, controlled studies for the prevention of relapse to recurrent depression, can be helpful for patients with HCV and their families in the self-management of the neuropsychiatric side effects of antiviral therapy. It will define characteristics of both patients and families who are willing to commit to an eight-week program that consists of a two-hour/week group session and daily homework exercises. It will describe characteristics of patients and family members who derive sufficient benefit to develop a regular program of self-monitoring and self-management based on the symptom-management skills they have acquired or strengthened through this intervention.
The aim of this study is to offer MBCT classes as a pre-treatment intervention to consecutive patients at the Yale and VA-CT liver clinics who are medically eligible for treatment for chronic HCV with interferon and ribavirin and who are neither acutely mentally ill nor actively abusing drugs or alcohol at the time of pre-treatment psychiatric evaluation. Patients will be asked to identify a significant family member or support person (partner) who is directly affected by the patient's illness and/or treatment who is willing to undergo the pre-treatment intervention with the patient.
We hypothesize that eligible patients will accept referral to the MBCT program; that they will be able to identify at least one partner who will actively participate in the program with them; that the enrolled patients and family members will complete the program; and that both patients and partners will develop an individualized, mindfulness-based, self-management practice. We also hypothesize that patients who have completed MBCT will not drop out of antiviral therapy (during the period encompassed by the study) because of exclusively neuropsychiatric side effects. Additionally, both patients and partners will report that this intervention supported treatment adherence and that there were no adverse effects of the intervention.
Design: This is a prospective, non-randomized, descriptive feasibility study of the acceptability of MBCT as a pre-treatment intervention
Subjects: A sample of 40 consecutive patients at Yale and the VA-CT liver clinics and 40 identified partners.
Setting: The VA-CT Donaldson Education Suite
Instruments: Logs of patients who enroll in the intervention and those who refuse; specific characteristics of both (including results of baseline psychiatric evaluations); attendance records; results of structured end of intervention evaluations; results of periodic, structured telephone assessments.
Procedures: Eligible patients recruited through liver clinics; initial psychiatric assessment/informed consent; four cycles of MBCT with a potential 24 patients per cycle; weekly maintenance sessions; monthly telephone assessment of benefit during antiviral treatment; end of intervention assessment of benefit for each cycle.
Data analysis: Descriptive, non-parametric statistics will be performed. Two groups will be compared (patients accepting and completing MBCT; patients who declined enrollment) according to descriptors that have been analyzed. Summaries of perceived benefit will be developed. A description of the characteristics of patients and partners who may be expected to benefit from MBCT in a setting of antiviral therapy for hepatitis C will be developed.
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