Table 3.
Assessment Time Period | T1 | T2 | T3 | T4 | ||
---|---|---|---|---|---|---|
HCV Treatment Time point |
Baseline Pre-Treatment |
Start of HCV Treatment | Week 12 HCV Treatment | Week 24 HCV Treatment |
||
CBCS-HCV Time point |
Baseline Start CBCS |
CBCS sessions 1–4 |
Session 5 | CBCS sessions 6–10 |
Final CBCS session 10 | 3-month Post-CBCS |
Study Feasibility | ||||||
Ratio of screens/enrollees | X | |||||
RCT Study Design | X | |||||
Retention Rates | X | X | X | X | X | X |
Study Visit Attendance | X | X | X | X | ||
CBCS Session Attendance | X | X | X | X | ||
Missing Data | X | X | X | X | X | X |
Patient Acceptability | X | X | X | X | ||
Protocol Fidelity | ||||||
Therapist's Adherence | X | X | X | X | ||
Therapist's Competence | X | X | X | X | ||
Demographics/Clinical | X | |||||
Psychosocial Surveys | ||||||
FACIT HRQOL | X | X | X | X | ||
PSS Stress Severity | X | X | X | X | ||
Depression | X | X | X | X | ||
Anger | X | X | X | X | ||
Anxiety | X | X | X | X | ||
Fatigue | X | X | X | X | ||
Sleep Disturbance | X | X | X | X | ||
Sleep Impairment | X | X | X | X | ||
Pain Intensity | X | X | X | X | ||
Pain Interference | X | X | X | X | ||
Medication Adherence | ||||||
MEMS Caps | X | X | X | |||
Pill Counts | X | X | X | |||
Self-Report Adherence | X | X | X | |||
Medical | ||||||
Treatment Completion | X | |||||
Virological Response | X | X | ||||
Process Measures | ||||||
Group Processes | X | |||||
MOCS | X | X | X | |||
Treatment Self-Efficacy | X | X | X |
T1: Baseline assessment after consent and screening.
T2: For participants in the CBCS-HCV condition, after CBCS session #5, immediately before starting HCV treatment. SC participants completed T2 immediately before starting HCV treatment.
T3: At HCV Treatment Week 12 for all study participants. Immediately following the last CBCS-HCV session for the CBCS-HCV participants.
T4: Three months post-intervention, at treatment week 24 for patients still on HCV treatment.