Data collection time point (→) | Pre-randomisation | Point of randomisation | Post randomisation | ||||
Key data capture (measures)/trial procedures (↓) | Baseline | Baseline | 1–15 weeks | 16 weeks* | 32 weeks | 52 weeks | |
Screening | ● | ||||||
Eligibility assessment | ● | ● | |||||
Consent to join trial and randomisation | ● | ||||||
Demographics | ● | ||||||
Revised clinical interview schedule | ● | ||||||
Beck Depression Inventory-II (primary outcome at 16 weeks) | ● | ● | ● | ● | |||
Generalised Anxiety Disorder Assessment | ● | ● | ● | ||||
Patient Health Questionnaire-9 (depression symptoms) | ● | ● | ● | ● | |||
Work and Social Adjustment Scale | ● | ● | ● | ||||
Self-rating of global change | ● | ● | ● | ||||
Positive And Negative Affect (PANAS-SF) | ● | ● | ● | ||||
Health-related quality of life (EQ-5D-5L and EQ-VAS) | ● | ● | ● | ● | |||
Work Productivity and Activity Impairment Questionnaire: General Health | ● | ● | ● | ● | |||
Health and social care resource use questions | ● | ● | ● | ||||
Guided self-help sessions* | |||||||
Case report form(s) - therapist records | |||||||
Working Alliance Inventory (Short Revised)* (therapist and participant rated) | ● | ● | |||||
Goal attainment record* | ● | ● | |||||
Qualitative interviews with patients and therapists† | |||||||
Carer substudy: Depression Anxiety Stress Scales and Warwick-Edinburgh Mental Well-Being Scale | ◊ | ◊ | ◊ |
Key: ● data capture/outcome measures; completion methods may vary depending on participant preferences. ◊ completed by caregiver.
*Intervention arm only.
†Months 6–12 decline/withdrawal qualitative interviews, months 10–20 end of treatment GSH participant qualitative interviews, 16–24 months TAU participant qualitative Interviews.
EQ-5D-5L, EuroQol five-dimension health status questionnaire ; EQ-VAS, EuroQol Visual Analogue Scale; GSH, guided self-help; PANAS-SF, Positive And Negative Affect Schedule-Short Form; TAU, treatment as usual .