Pilot Feasibility Study of a Cognitive Behavioral Coping Skills (CBCS) Group Intervention for Hep C Therapy Patients

A Pilot Feasibility Study of a Cognitive Behavioral Coping Skills (CBCS) Group Intervention for Patients Undergoing Antiviral Therapy for Chronic Hepatitis C

This is a pilot feasibility study of a small randomized controlled trial (RCT)design to evaluate participation in a Cognitive Behavioral Coping Skills (CBCS) group intervention versus standard of care in patients with hepatitis C undergoing antiviral treatment. The primary objectives are to (1) examine effect size (ES) estimates of key outcomes to provide essential data to inform a larger efficacy trial, (2) determine whether clinically significant improvements occurred in any key outcomes, and (3) evaluate study feasibility and patient acceptability. Study findings will inform a larger efficacy study of the CBCS-HCV.

This is a pilot feasibility study of a Cognitive Behavioral Coping Skills (CBCS) Group Intervention with a representative sample of patients with Hepatitis C viral (HCV)undergoing standard antiviral treatment in a small RCT to examine (1) study feasibility, (2) effect size estimates, and (3) whether clinically significant improvements occurred in key outcomes. This pilot study will allow the investigators to test the hypotheses that the study procedures are feasible and that participation in the CBCS-HCV group is acceptable and useful to participants. Furthermore, effect size estimates of key outcome variables will determine which outcomes appear to improve as a result of the intervention and should potentially be evaluated in a future efficacy study. Several patient-reported outcomes (PROs) are evaluated: health-related quality of life (HrQOL), perceived stress, depression, anxiety, anger, fatigue, sleep, pain and medication adherence. The investigators will also determine if group participation affects viral cure rate. Change scores that have an effect size d> .35 are considered potentially clinically significant and reasonable to evaluate in a larger efficacy study. Study feasibility elements evaluated included: feasibility of a RCT study design, intervention delivery, patient acceptability, therapist protocol fidelity, recruitment, enrollment, attendance, retention and data collection.

The investigators planned to enroll and evaluate the intervention in two waves of study participants (Wave 2, Wave 3). When a block of 12 patients is consented for Wave 2, participants will be randomized to standard of care (SC; n=6) or the CBCS-HCV group intervention (n=6). The same procedure will be used to consent and randomize 12 patients in Wave 3 to SC vs CBCS-HCV. Patients randomized to CBCS will participate in 4 weekly CBCS sessions prior to starting HCV treatment, and 5 more sessions during HCV treatment, on the same day they attend follow-up treatment visits at weeks 2, 4, 6, 8, and 12. Outcome data will be collected at baseline (T1), just prior to HCV treatment starting (T2); at week 8 of HCV treatment (T3), at end of CBCS intervention/ HCV treatment at week 12 (T4), and 1-month post-CBCS intervention/ HCV treatment (T5). The primary outcome is change in total HrQOL score. Secondary outcomes are change in other PROs noted above. Additional secondary outcomes are group differences in medication adherence and viral cure rate. Elements of study feasibility are also evaluated.

Inclusion Criteria:

• All English -speaking adult patients (age 21 or older) with HCV;
• Treatment-naïve or treatment experienced;
• Deemed eligible for standard antiviral therapy for HCV by the clinical providers by standard clinical criteria;
• Referred by HCV clinician or on "Treatment Waitlist" ready to start a 12-week prescribed course of antiviral therapy.

Exclusion Criteria:

• Prescribed a 24-week antiviral treatment regimen;
• Inability to provide written informed consent;
• Currently participating in another pharmaceutical clinical trial of hepatitis C therapeutics;
• Evidence of use of illicit substances (excluding marijuana) reported in the last 6 months by patient during screening or noted in patient's medical record
• Current significant suicidal ideation reported during Screening or noted in patient's medical record
• Current significant personality disorder or features reported during Screening or noted in patient's medical record that is clinically judged to be detrimental to the group therapeutic setting for other group participants
• Cannot make personal commitment to attend study visits and/or intervention sessions
• Is medically or psychiatrically contraindicated to proceed with HCV antiviral therapy at the time of study enrollment.