NCT03057236

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

February 15, 2017

Last Update Submit

February 17, 2017

Conditions

Hepatitis CHepatitis C, Chronic

Keywords

psychological, behavioral, psychosocial, antiviral, liver

Outcome Measures

Primary Outcomes (1)

  • Change in health related quality of life score from T1 to T2

    HRQOL is measured using the Functional Assessment of Cancer Therapy-General Population (FACT-GP). The FACT-GP is an instrument derived from the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to measure HRQOL during the management of chronic illness. The FACT-GP is a 21-item survey that assesses four HRQOL domains: Physical well-being; Social/Family well-being; Emotional well-being; and Functional well-being. Items are rated on a five-category response system ranging from 0 (not at all) to 4 (very much). Higher scores indicate higher (better) HRQOL. Change in the total HRQOL score from T1 to T2 was the primary outcome measure, with an effect size d\>.35 indicating a small to moderate clinical improvement

    4 weeks

Secondary Outcomes (15)

  • Change in 4 HRQOL subscale scores (physical well-being, emotional well-being, social well-being, functional well-being) from T1 to T5

    20 weeks

  • Change in 4 HRQOL subscale scores (physical well-being, emotional well-being, social well-being, functional well-being) from T1 to T2

    4 weeks

  • Change in perceived stress scale score from T1 to T2

    4 weeks

  • Change in perceived stress scale score from T1 to T5

    20 weeks

  • Change in 8 PROMIS symptom scores from T1 to T2

    4 weeks

  • +10 more secondary outcomes

Study Arms (2)

Standard of Care

NO INTERVENTION

This arm does not receive the behavioral intervention. Participants will complete HCV treatment per standard of care.

Cognitive Behavior Coping Skills

EXPERIMENTAL

The CBCS intervention is a structured module-based group intervention involving 9, 2-hour sessions. Participants will participate in 4 weekly sessions before HCV treatment to learn and practice new cognitive behavioral skills, and 5 sessions during HCV treatment at weeks 2, 4, 6, 8, and 12.

Behavioral: Cognitive Behavior Coping Skills

Interventions

Cognitive Behavior Coping SkillsBEHAVIORAL

The CBCS-HCV is a psychosocial intervention delivered in group format. Through 9 group sessions, patients will learn coping skills, relaxation techniques and other new cognitive and behavioral skills based on several empirically-supported cognitive behavioral interventions.

Also known as: CBCS-HCV
Cognitive Behavior Coping Skills

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Evon DM, Golin CE, Ruffin R, Ayres S, Fried MW. 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. Pilot Feasibility Stud. 2018 Jun 27;4:92. doi: 10.1186/s40814-018-0285-5. eCollection 2018.

    PMID: 29983993DERIVED

MeSH Terms

Conditions

Hepatitis CHepatitis C, ChronicBehavior

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Donna Evon, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are assigned to Standard of Care group or the Intervention (CBCS) group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 20, 2017

Study Start

March 1, 2014

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

February 20, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)