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

NCT02558647 | Unknown

• 2 other identifiers: NFR:239985HUNT-SHUTi
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 2

Brief Summary

Insomnia is a major public health concern. While cognitive behavior therapy for insomnia (CBT-I) is acknowledged as the best available intervention, there are unanswered questions about its wider dissemination, socio-economic benefits and its impact on health resource utilization. The aim of this randomized controlled trial (RCT) is to investigate the effectiveness of a fully automated online version of CBT-I compared with online patient education about sleep (PE). Outcome measures comprise changes in symptoms of insomnia, time off work due to sick leave, as well as medication and health resource utilization. Also, we will examine putative mediators and selected potential psycho-bio-social moderators of the effects of the intervention.

Conditions

Insomnia

Keywords

therapy; CBT-I; internet-based; online; short-term benefits; medium-term outcomes; health resource use; sick leave

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index, ISI

  The ISI will be used to assess self-reported levels of insomnia severity. Range is 0-28. Higher values represent higher levels of insomnia symptom severity.

  Pre to 9 weeks post randomization (post treatment assessment)

Secondary Outcomes (26)

• Insomnia Severity Index, ISI

  Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)

• Sleep diaries

  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

  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)

• Short Form-12, SF-12

  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

  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)

Other Outcomes (1)

• Salivary sample

  Single sample 24 months and 9 weeks after randomization (depending on funding/ethics approval for this component of the study)

Study Arms (2)

CBT for insomnia (CBT-I)

EXPERIMENTAL

Internet-based cognitive-behavioral therapy for insomnia (CBT-I) comprises a fully automated, interactive, and tailored web-based program that incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention

Behavioral: CBT for insomnia (CBT-I)

Psychoeducation about Sleep (PE)

ACTIVE COMPARATOR

The PE intervention gives participants access to a website with information about insomnia symptoms; the impact, prevalence, and causes of insomnia; when to seek input from a doctor; and basic lifestyle, environmental, and behavioral strategies that may help to improve sleep.

Behavioral: Psycho-Education about Sleep (PE)

Interventions

CBT for insomnia (CBT-I) BEHAVIORAL

CBT-I is an online, fully automated, interactive, and tailored web-based program that incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention.

Also known as: SHUTi

CBT for insomnia (CBT-I)

Psycho-Education about Sleep (PE) BEHAVIORAL

PE provides online information about insomnia symptoms; the impact, prevalence, and causes of insomnia; when to seek input from a doctor; and basic lifestyle, environmental, and behavioral strategies that may help to improve sleep.

Also known as: passive education/ sleep hygeine

Psychoeducation about Sleep (PE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (2)

Norwegian Institute of Public Health

Bergen, 5000, Norway

Location

NTNU

Trondheim, Norway

Location

Related Publications (4)

• Skoglund H, Sivertsen B, Kallestad H, Vedaa O. Digital cognitive behavioral therapy for insomnia for people with comorbid psychological distress: A large scale randomized controlled trial. Sleep Med. 2024 Sep;121:241-250. doi: 10.1016/j.sleep.2024.06.026. Epub 2024 Jun 28.

  PMID: 39024778 DERIVED

• Vestergaard CL, Vedaa O, Simpson MR, Faaland P, Vethe D, Kjorstad K, Langsrud K, Ritterband LM, Sivertsen B, Stiles TC, Scott J, Kallestad H. The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. Sleep. 2021 Oct 11;44(10):zsab118. doi: 10.1093/sleep/zsab118.

  PMID: 33964166 DERIVED

• Vedaa O, Kallestad H, Scott J, Smith ORF, Pallesen S, Morken G, Langsrud K, Gehrman P, Thorndike FP, Ritterband LM, Harvey AG, Stiles T, Sivertsen B. Effects of digital cognitive behavioural therapy for insomnia on insomnia severity: a large-scale randomised controlled trial. Lancet Digit Health. 2020 Aug;2(8):e397-e406. doi: 10.1016/S2589-7500(20)30135-7.

  PMID: 33328044 DERIVED

• Kallestad H, Vedaa O, Scott J, Morken G, Pallesen S, Harvey AG, Gehrman P, Thorndike F, Ritterband L, Stiles TC, Sivertsen B. Overcoming insomnia: protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep. BMJ Open. 2018 Aug 30;8(8):e025152. doi: 10.1136/bmjopen-2018-025152.

  PMID: 30166311 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study participants are randomized to CBT-I or a potential active comparator (PE). Follow-up data is primarily self-report; data on sick leave etc is objective data obtained form national registers, with investigators are blinded to participant identity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Model Details: This is a parallel-group superiority RCT comparing internet-delivered CBT-I (a Norwegian language version of SHUTi) with online patient education about sleep (PE).

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 24, 2015
• Study Start: February 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2021
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

NO (2)