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NCT03057236

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

Completed NA Last updated 20 February 2017
What this trial tests

NA trial testing Cognitive Behavior Coping Skills in Hepatitis C in 20 participants. Completed in 31 December 2014.

Timeline
1 March 2014
Primary endpoint
31 December 2014
31 December 2014

Quick facts

Lead sponsorUniversity of North Carolina, Chapel Hill
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment20
Start date1 March 2014
Primary completion31 December 2014
Estimated completion31 December 2014
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of North Carolina, Chapel Hill

Who can join

21 and older, any sex, with Hepatitis C or Hepatitis C, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Novel patient-reported outcomes (PROs) used in a pilot and feasibility study of a Cognitive Behavioral Coping Skills (CBCS) group intervention for patients with chronic hepatitis C.
    Evon DM, Golin CE, Ruffin R, Ayres S, et al · · 2018 · cited 5× · PMID 29983993 · DOI 10.1186/s40814-018-0285-5

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Other recruiting trials for Hepatitis C

Currently open trials in the same condition.

Other University of North Carolina, Chapel Hill trials

Trials by the same sponsor.

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Data sources for this page

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