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

Completed · Not applicable

Conditions studied: Hepatitis C, Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT03057236

Run by

University of North Carolina, Chapel Hill

People needed

20

Starts

2014-03-01

Expected to finish

2014-12-31

Last updated by the study team

2017-02-20

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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