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Table 1 Study outcome measurements and time points

From: Does the guided online cognitive behavioral therapy for insomnia “i-Sleep youth” improve sleep of adolescents and young adults with insomnia after childhood cancer? (MICADO-study): study protocol of a randomized controlled trial

Measurement

Instrument

Nr. of items

Time-points

Baseline (T0-months)

Post treatment (T3 months)

Follow-up

T6 months

Follow-up

T12* months

Primary outcomes

 Sleep efficiency (SE)

Actigraph and sleep log

X

X

X

X

 Insomnia Severity

ISI

7

Assessed in screening

X

X

X

Secondary outcomes:

 Sleep parameters: TST, TTB, SOL, WASO, napping

Actigraph and sleep log

 

X

X

X

X

 Circadian rhythm parameters: Fragmentation (IV) and intradaily stability (IS)

Actigraph and sleep log

 

X

X

X

X

 Health-Related (HR) quality of life

PedsQL

- teens 13–18 years

- young adult 19–30 years

23

X

X

X

X

 Fatigue

CIS

20

X

X

X

X

 Depressive and anxiety symptoms

HADS

14

X

X

X

X

 Perceived cognitive functioning

Peds-PCF-SF

10

X

X

X

X

 Chronic stress

CSQ-CA

19

X

 

X

X

 General questionnaire

Pain

Sleep medication use

2

X

X

X

X

 Intervention feedback

Satisfaction questionnaire, adherence

20

 

X*/X**

 
  1. Notes.*only intervention-condition, **at 9 months for control-condition. TST total sleep time, TTB total time in bed, SOL sleep onset latency, WASO wake after sleep onset, ISI Insomnia Severity Index, CIS Checklist Individual Strength, HADS Hospital Anxiety and Depression Scale, Peds-PCFSF Peds Perceived Cognitive functioning Short Form, CSQ-CA Chronic Stress Questionnaire for Childs and Adolescents