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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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This is a two-arm RCT that assesses the benefits of online CBT-I compared with an alternative, active control intervention (online patient education about sleep (PE)). We will randomize 1500 individuals and collect follow-up data for up to two years. First, we will examine any differential change in the severity of insomnia, immediately after completing the interventions. Secondly, we will examine if there are differential changes in symptoms of physical and mental health (e.g. psychological distress, fatigue, and health related quality of life) immediately post-intervention, and whether any improvements in insomnia or other symptoms are reported at further follow-ups (6- and 24 months post treatment termination). Third, we will use national registry data collected routinely in Norway to compare rates of time off work due to sick leave days for up to two years before and after participating in the RCT, as well as monitoring medication and health resource utilization according to condition in the same time interval. Fourth, we will try to extend the knowledge base about online interventions by undertaking exploratory analyses to assess whether change in specific clinical variables (e.g. sleep variability, psychological measures of beliefs about sleep) mediate the effects of the CBT-I intervention. Lastly, (subject to additional funding to collect saliva samples), we will examine a subset of psycho-bio-social factors to try to identify potential treatment moderators that might inform the stratification of individuals with insomnia into 'treatment-relevant' subgroups in the future (e.g. this may include also an exploration of 'therapygenetics').

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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CBT for insomnia (CBT-I)

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

Group Type EXPERIMENTAL

CBT for insomnia (CBT-I)

Intervention Type 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.

Psychoeducation about Sleep (PE)

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.

Group Type ACTIVE_COMPARATOR

Psycho-Education about Sleep (PE)

Intervention Type 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.

Interventions

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CBT for insomnia (CBT-I)

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.

Intervention Type BEHAVIORAL

Psycho-Education about Sleep (PE)

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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SHUTi passive education/ sleep hygeine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes