Table 1

Trial assessments and key participant-related procedures

Data collection time point (→)Pre-randomisationPoint of randomisationPost randomisation
Key data capture (measures)/trial procedures (↓)BaselineBaseline1–15 weeks16
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† Embedded Image
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 .