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Table 2 Overview of the assessments utilized in the randomized controlled trial

From: Group-delivered cognitive behavioural therapy versus waiting list in the treatment of insomnia in primary care: study protocol for a pragmatic, multicentre randomized controlled trial

Objective

Measure

Measurement timepoint

Participant group

Demographic information

Self-rated custom questions

T1

All

Primary outcome

Insomnia severity (Insomnia severity index)

Screening, T1, T2, T3, T4

Secondary outcomes

Health-related quality of life (EuroQol EQ5D-5L)

T1, T2, T3, T4

Fatigue (Chalder Fatigue Scale)

T1, T2, T3, T4

Mental distress (Hopkins Symptoms Checklist)

T1, T2, T3, T4

Moderator

Chronotype (Brief Horne-Östberg Morningness-Eveningness Questionnaire)

T1, T2, T3, T4

Mediators

Unhelpful beliefs about sleep (Dysfunctional Beliefs and Attitudes about Sleep questionnaire-16)

T1, T2, T3, T4

Sleep reactivity (Ford Insomnia Response to Stress Test)

T1, T2, T3, T4

Subjective assessment of sleep patterns

7-day sleep diary

T1, T2, T3, T4

Mixed-method process evaluation of facilitators and barriers of participants’ treatment adherence in group-delivered CBT-I

Motivation for treatment (Nijmegen Motivation List 2)

T1

 ~ 60 intervention group participants

Treatment credibility (Credibility / Expectancy Questionnaire)

T1

Adherence to CBT-I components (Treatment Components Adherence Scale)

T3

Evaluation of treatment (CBT-I evaluation scale)

T3

Individual semi-structured interviews

T2, T3

10–12 intervention group participants

Evaluation of sick leave rates, medication use, and healthcare services utilization

Norwegian Patient Registry

T5, T6

All intervention group participants

Norwegian Prescription Database

T5, T6

National Insurance Administration

T5, T6