Overcoming Insomnia: Impact on Sleep, Health and Work of Online CBT-I

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02558647
• Date of registration: 23/09/2015
• Prospective Registration: Yes
• Primary sponsor: Norwegian Institute of Public Health
• Public title: Overcoming Insomnia: Impact on Sleep, Health and Work of Online CBT-I NORSE-3
• Scientific title: Overcoming Insomnia: A Large-scale Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia Compared With Online Patient Education About Sleep.
• Date of first enrolment: February 2016
• Target sample size: 1500
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02558647
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Norway

Key inclusion & exclusion criteria

Inclusion criteria:

- Individuals aged >=18 years who score >= 12 on the Insomnia Severity Index (a score
indicative of insomnia symptoms that significantly impact on individuals)

- Willing and able to give online informed consent.

Exclusion criteria:

- Individuals scoring >10 on the Epworth Sleepiness Scale (ESS) (which is suggestive of
excessive daytime sleepiness) and/or answering that they usually or every day snore
and stop breathing and have difficulties staying awake during the day (i.e., they
positively endorse pre-selected indicators of sleep apnoea);

- Self-report of the presence of any medical conditions where a fully automated CBT-I
may be contra-indicated (e.g. epilepsy, bipolar disorder, schizophrenia or psychotic
disorders, and recent heart surgery)

- Participating in shift work.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Insomnia

Intervention(s)

Behavioral: Psycho-Education about Sleep (PE)

Behavioral: CBT for insomnia (CBT-I)

Primary Outcome(s)

Insomnia Severity Index, ISI [Time Frame: Pre to 9 weeks post randomization (post treatment assessment)]

Secondary Outcome(s)

Absence from work and loss of productivity [Time Frame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Body Mass Index [Time Frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Dysfunctional Beliefs About Sleep scale, DBAS [Time Frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Physical health [Time Frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Alcohol use disorders identification test - consumption , AUDIT-C [Time Frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Electronic Media Use [Time Frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Mental health [Time Frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Pain site [Time Frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Hospital Anxiety and Depression Scale, HADS [Time Frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Physical activity [Time Frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Internet intervention evaluation [Time Frame: 9 weeks after randomization (post assessment), and 24 months follow-up (24 months and 9 weeks after randomization)]

Brief Horne-Östberg Morningness-Eveningness Questionnaire, MEQ [Time Frame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Negative Effects Questionnaire, NEQ [Time Frame: 24 months follow-up (24 months and 9 weeks after randomization)]

Use of health care services [Time Frame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Use of sleep strategies questionnaire [Time Frame: 24 months follow-up (24 months and 9 weeks after randomization)]

Insomnia Severity Index, ISI [Time Frame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Help seeking behavior [Time Frame: 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Short Form-12, SF-12 [Time Frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

National Insurance Administration (NIA) [Time Frame: Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization]

Impact of health problems on productivity [Time Frame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Norwegian Patient Registry (NPR) [Time Frame: Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization]

Sleep diaries [Time Frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Chalder Fatigue Questionnaire, CFQ [Time Frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Medication use [Time Frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Norwegian Prescription Database (NorPD) [Time Frame: Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization]

The Bergen Insomnia Scale, BIS [Time Frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)]

Secondary ID(s)

NFR:239985

HUNT-SHUTi

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Norwegian University of Science and Technology