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Table 2 Time Course of Study Measures

From: Efficacy of cognitive behavioral therapy for insomnia and lemborexant medication for different subtypes of chronic insomnia: study protocol for a randomized controlled trial

 

Screening/

Eligibility

(- 4 weeks)

Baseline

(− 2 weeks)

Six consultations over an 8-week treatment period

Weeks 0–8

Post-Treatment

2 weeks

Weeks 9–10

Follow-Up

6-month

Weeks 26–27 after end of treatment

Screening Measures (Demographics, health, sleep disorders)

 Sociodemographics, medical and medications checklist,

X

    

 Duke Sleep Interview

X

    

 Mini-International Neuropsychiatric Interview, STOP-Bang, International Restless Legs Questionnaire, Epworth Sleepiness Scale

X

    

 EEG (7 nights), actigraphy (7 days and nights)

 

X

 

X

 

Outcome Measures (Sleep, insomnia, daytime symptoms, burden)

 Consensus sleep diary

X

X

X

X

X

 Insomnia Severity Index

X

X

X

X

X

 Patient Health Questionnaire-9

X

X

 

X

X

 Generalized Anxiety Disorder 7-item

X

X

 

X

X

 Dysfunctional Beliefs and Attitudes about Sleep

 

X

 

X

X

 Fatigue Severity Scale

 

X

 

X

X

 Work and Social Impairment Scale

 

X

 

X

X

 WHO-5 Well-Being Index

 

X

 

X

X

 Cognitive Failures Questionnaire 2.0

 

X

 

X

 

Treatment-Related Measures

 Treatment acceptability and satisfaction

 

X

 

X

X

 Treatment adherence scale

  

X

  

 Ford Insomnia Response to Stress Test, Arousal Predisposition Scale, Pre-Sleep Arousal Scale

X

 

X

X

 

 Adverse Events (Systematic Assessment for Treatment Emergent Events)

 

X

X

X

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