Clinical trial NCT02558647: Overcoming Insomnia: Impact on Sleep, Health and Work of Online CBT-I
Official title: Overcoming Insomnia: A Large-scale Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia Compared With Online Patient Education About Sleep.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: therapy
CBT-I
internet-based
online
short-term benefits
medium-term outcomes
health resource use
sick leave
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: Norwegian University of Science and Technology
First posted: 2015-09-24
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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').

Eligibility 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.

Primary outcomes:
measure: Insomnia Severity Index, ISI
timeFrame: Pre to 9 weeks post randomization (post treatment assessment)
Secondary outcomes:
measure: Insomnia Severity Index, ISI
timeFrame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
measure: Sleep diaries
timeFrame: 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)
measure: Hospital Anxiety and Depression Scale, HADS
timeFrame: 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)
measure: Short Form-12, SF-12
timeFrame: 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)
measure: Dysfunctional Beliefs About Sleep scale, DBAS
timeFrame: 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)
measure: Chalder Fatigue Questionnaire, CFQ
timeFrame: 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)
measure: The Bergen Insomnia Scale, BIS
timeFrame: 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)
measure: Brief Horne-Östberg Morningness-Eveningness Questionnaire, MEQ
timeFrame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
measure: Physical health
timeFrame: 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)
measure: Mental health
timeFrame: 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)
measure: Pain site
timeFrame: 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)
measure: Alcohol use disorders identification test - consumption , AUDIT-C
timeFrame: 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)
measure: Body Mass Index
timeFrame: 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)
measure: Physical activity
timeFrame: 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)
measure: National Insurance Administration (NIA)
timeFrame: Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization
measure: Norwegian Patient Registry (NPR)
timeFrame: Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization
measure: Norwegian Prescription Database (NorPD)
timeFrame: Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization
measure: Help seeking behavior
timeFrame: 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)
measure: Medication use
timeFrame: 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)
measure: Use of health care services
timeFrame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
measure: Absence from work and loss of productivity
timeFrame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
measure: Impact of health problems on productivity
timeFrame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
measure: Internet intervention evaluation
timeFrame: 9 weeks after randomization (post assessment), and 24 months follow-up (24 months and 9 weeks after randomization)
measure: Electronic Media Use
timeFrame: 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)
measure: Negative Effects Questionnaire, NEQ
timeFrame: 24 months follow-up (24 months and 9 weeks after randomization)
measure: Use of sleep strategies questionnaire
timeFrame: 24 months follow-up (24 months and 9 weeks after randomization)
Other outcomes:
measure: Salivary sample
timeFrame: Single sample 24 months and 9 weeks after randomization (depending on funding/ethics approval for this component of the study)
Locations:
city: Bergen
country: Norway
facility: Norwegian Institute of Public Health
city: Trondheim
country: Norway
facility: NTNU
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.