Clinical trial NCT03057236: Pilot Feasibility Study of a Cognitive Behavioral Coping Skills (CBCS) Group Intervention for Hep C Therapy Patients
Official title: A Pilot Feasibility Study of a Cognitive Behavioral Coping Skills (CBCS) Group Intervention for Patients Undergoing Antiviral Therapy for Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Hepatitis C, Chronic
Keywords: psychological, behavioral, psychosocial, antiviral, liver
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to Standard of Care group or the Intervention (CBCS) group.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in health related quality of life score from T1 to T2
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in 4 HRQOL subscale scores (physical well-being, emotional well-being, social well-being, functional well-being) from T1 to T5
timeFrame: 20 weeks
measure: Change in 4 HRQOL subscale scores (physical well-being, emotional well-being, social well-being, functional well-being) from T1 to T2
timeFrame: 4 weeks
measure: Change in perceived stress scale score from T1 to T2
timeFrame: 4 weeks
measure: Change in perceived stress scale score from T1 to T5
timeFrame: 20 weeks
measure: Change in 8 PROMIS symptom scores from T1 to T2
timeFrame: 4 weeks
measure: Change in 8 PROMIS symptom scores from T1 to T5
timeFrame: 20 weeks
measure: Pill count medication adherence
timeFrame: 12 weeks
measure: Viral cure after HCV treatment
timeFrame: 20 weeks
measure: study feasibility 1: Feasibility of recruitment
timeFrame: 3 months
measure: study feasibility 2: Feasibility of randomization
timeFrame: 3 months
measure: study feasibility 3: Feasibility of enrollment
timeFrame: 3 months
measure: study feasibility 4: Feasibility of data collection
timeFrame: 20 weeks
measure: study feasibility 5: Patient retention and acceptability
timeFrame: 16 weeks
measure: Patient acceptability and comprehension
timeFrame: 16 weeks
measure: Therapist Competency in intervention delivery
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Donna Evon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.