Table 3.
Data collection and assessment schedule.
| 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.