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

Change in each of the 4 HRQOL subscale scores derived from the FACIT-GP will be evaluated. Items are rated on a five-point system ranging from 0 (not at all) to 4 (very much). Higher scores indicate higher (better) physical, emotional, social, and functional well-being. Change in these 4 subscale scores from T1 to T5 evaluates change from baseline to 1 month post-intervention/post-HCV treatment. An effect size change of d>.35 would indicate a small to moderate clinical improvement

Change in each of the 4 HRQOL subscale scores derived from the FACIT-GP will be evaluated. Items are rated on a five-point system ranging from 0 (not at all) to 4 (very much). Higher scores indicate higher (better) physical, emotional, social, and functional well-being. Change in these 4 subscale scores from T1 to T2 evaluates change after 4 CBCS sessions. An effect size change of d>.35 would indicate a small to moderate clinical improvement

The Perceived Stress Scale (PSS) is a widely used survey to measure stress perception. The scale includes 10 items, rated using a 5-point Likert scale, from 0 (never) to 4 (very often) where patients report the frequency of symptoms in the past month. The PSS has been shown to have good reliability and validity. Higher stress scores represent a worse outcome. T1 to T2 measures change after 4 CBCS sessions. An effect size change of d>.35 indicates a small to moderate clinical improvement

The Perceived Stress Scale (PSS) is a widely used survey to measure stress perception. The scale includes 10 items, rated using a 5-point Likert scale, from 0 (never) to 4 (very often) where patients report the frequency of symptoms in the past month. The PSS has been shown to have good reliability and validity. Higher stress scores represent a worse outcome. T1 to T5 measures change from baseline to 1 month post-intervention/post HCV treatment. An effect size change of d>.35 indicates a small to moderate clinical improvement

PROMIS symptom surveys measured 8 constructs: depression, anxiety, anger, fatigue, pain, sleep disturbance, sleep impairment, pain intensity, and pain interference. These surveys utilize 4-8 items each with higher scores indicating higher (worse) symptoms. The PROMIS surveys are derived from the Patient-Reported Outcome Measurement Information System (PROMIS). Responses are scored 1 to 5 for each item with higher scores representing worse outcomes. Raw total scores are translated into T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. T1 to T2 measures change from baseline to after 4 CBCS sessions. An effect size change of d>.35 indicates a small to moderate clinical improvement

PROMIS symptom surveys measured 8 constructs: depression, anxiety, anger, fatigue, pain, sleep disturbance, sleep impairment, pain intensity, and pain interference. These surveys utilize 4-8 items each with higher scores indicating higher (worse) symptoms. The PROMIS surveys are derived from the Patient-Reported Outcome Measurement Information System (PROMIS). Responses are scored 1 to 5 for each item with higher scores representing worse outcomes. Raw total scores are translated into T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. T1 to T5 measures change from baseline to 1 month post-intervention/post-HCV treatment. An effect size change of d>.35 indicates a small to moderate clinical improvement

To assess medication adherence from week 2 to 12 of HCV treatment, patients brought HCV medication bottles to clinic and pills were counted at treatment weeks 2, 4, 6, 8, and 12 if a patient had a standard clinical visit. The number of pills remaining in the pill bottle were monitored to determine ideal vs actual proportion of pills taken between clinic visits. The proportion of pills taken at each visit was added then divided by the number of visits to obtain an overall proportion of medical adherence.

Medical records were reviewed for lab results for HCV RNA viral load after treatment had ended for at least 4 weeks. Lab data for HCV RNA indicated "detectable virus: or "undetectable virus" indicating whether viral cure had been achieved.

Feasibility of recruitment efforts will be determined by the proportion of patients contacted for screening via phone versus those who are consented

Feasibility of randomization will be determined by whether the investigators were able to enroll and randomize a block of 12 participants for Wave 2 and Wave 3

Feasibility of enrollment will be determined by the proportion of patients consented vs those enrolled and randomized

Feasibility of data collection will be determined by the overall proportion of surveys completed by each participant at each of the 5 timepoints (T1-T5)

Patient acceptability of the CBCS intervention will be determined by retention, defined as the overall number of CBCS sessions attended by each patient and the proportion of patients who started and finished the intervention

CBCS-HCV participants will complete a 14-item brief survey administered by a research coordinator at the end of each of the 9 sessions to rate the session on acceptability, usefulness, comprehension, and group process. Each item is rated on a five-point Likert scale from "1=Not At All" to "4=A lot/Extremely" with higher scores indicating greater patient acceptability. The survey was adapted from one developed by previous interventionists to examine intervention acceptability.

Study staff will observe the delivery of each of the 9 CBCS module-based sessions and complete an observer-rating form of the therapist's competency. Ratings are made on 14 items based on the following Likert scale: 1=Not At All; 2=A little; 3=moderately; and 4=A lot/Extremely with higher scores indicating greater competency to manage group dynamics and demonstrate awareness of the nonspecific therapeutic processes.