Table 1

Overview of (the timing of) the patient-reported outcome measures (PROMs)

MeasurementInstrument (PROMM)Timing
(Baseline, week 6, 12, 20, 52)
Background characteristicsStudy-specific sex, age, body length and weight, highest attained educational level, current work status, smoking status, alcohol consumption, duration of insomnia, sleep treatment history.Baseline
Sleep–main outcomeInsomnia Severity Index (ISI)*37 All time points
Sleep–other outcomesPittsburgh Sleep Quality Index (PSQI)* 50 items 1–4 and the number of nights per week in which the participant experienced sleep problems.All time points
Global rate of change 51
Sleep problem compared with baseline.
Week 6, 12, 20
Consensus sleep diary,52 pen-and-paper version, prospectively for 1 week.Baseline, week 6 and 20
Functional impairments due to sleep problemWork and Social Adjustment Scale (WSAS)* 53 All time points
Glasgow Sleep Impact Index (GSII)42 part 1, 2 and 3.All time points
FatigueMultidimensional Fatigue Inventory (MFI)*54 Baseline, week 12 and 20
Flinders Fatigue Scale (FFS)55 items 4 and 6.Baseline, week 12 and 20
Emotional complaintsHospital Anxiety and Depression Scale (HADS),* 56 validated Dutch version.57 Baseline, week 12 and 20
Side effectsAntidepressant Side-Effect Checklist (ASEC-21),* 58 Dutch translation.59† At baseline symptom rate only. At follow-up in relation to treatment and current dose.Baseline, week 6 and 12/
in case of treatment discontinuation as soon as possible.
Self-reported in kg.
All time points
WithdrawalDiscontinuation-Emergent Signs and Symptoms (DESS) checklist,60 Dutch translation.61Week 20/in case of treatment discontinuation in combination with the next planned questionnaire.
Treatment evaluationStudy-specific details of usage (dose, timing of taking tablets), adherence and (reasons for) missed tablets and treatment satisfaction.Week 20/in case of treatment discontinuation in combination with the next planned questionnaire.
Additional measures to improve sleep +life eventsStudy-specific other measures to improve sleep used by the participant; retrospectively over the intervention period and over the period after the intervention, life-events affecting sleep.Week 20 and week 52.
  • *Recall period adapted to past 2 weeks.

  • †Adapted for self-administration in insomnia disorder patients. The item ‘sleep problem’ was in the ASEC-21 replaced by the items ‘difficulty waking up’, ‘sleepiness in the morning’, ‘sleepiness in the afternoon’, ‘vivid dreams/disturbed sleep’ and omitted from the DESS list and evaluated in a separate item.