A randomized controlled trial comparing guided internet-based multi-component treatment and internet-based guided sleep restriction treatment to care as usual in insomnia

Krieger, Tobias; Duss, Simone B.; Blättler, Larissa Tatjana; Schmitt, W; Gast, Heidemarie; Berger, Thomas

doi:10.1016/j.sleep.2019.01.045

Cited by 23 publications

(30 citation statements)

References 45 publications

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“…Furthermore, participants starting the program are encouraged to contact a specialist via feedback form if they face technical or methodological difficulties with the program have questions or suffer from negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study (11).…”

Section: Interventionmentioning

confidence: 99%

“…The 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8)(9)(10)(11)(12)(13)(14); moderate insomnia (15-21); and severe insomnia (22-28) (51). The response criterion is determined as decrease of the ISI score of more than 7 points compared to baseline (52).…”

Section: Primary Outcome Measuresmentioning

confidence: 99%

“…We aim to detect a small to medium between-group effect size (Cohen's d) of 0.35 at post-treatment. The chosen effect size is reasonable since CAU being an active alternative treatment may decrease between-group outcome differences and a smaller effect size was considered to be irrelevant from a clinical point of view (11). Based on a-level of.05 and a power of.95 using a single-level repeated measures ANOVA power analysis with G*Power (71), the sample size needed is approximately 55 participants per group and 110 for the total sample.…”

Section: Sample Size Calculationmentioning

confidence: 99%

“…CBT-I consists of sleep restriction, stimulus control, various relaxation techniques, sleep hygiene education, and cognitive restructuring of maladaptive beliefs and concerns about sleep. Although particular treatment elements have shown its effectiveness, the multimodal approach has the highest level of evidence for the management of CI (9)(10)(11). The therapeutic effects of CBT-I are similar to or higher (especially at long-term) than those of hypnotic drugs (12).…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness and Cost-Effectiveness of Internet-Based Cognitive Behavioral Therapy for Insomnia in Clinical Settings

et al. 2020

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Background: Internet-delivered cognitive-behavior treatment for insomnia (iCBT-I) has the potential to fill the gap created by the discrepancy between insomnia cases and number of trained professionals. Although the effectiveness of this method was proven in multiple studies conducted in research settings, its feasibility in routine care is still unclear. Predictors, mediators, and moderators of treatment effect remain uncertain since previous studies often give contradictory results. The present study aims to investigate clinical effectiveness and cost-effectiveness of an internet-based CBT-I program Sleepsy in comparison with care as usual (CAU) among patients with CI recruited from clinical settings. Baseline data will be further analyzed to find predictors of treatment outcome. Methods/Design: The proposed study is a parallel-group randomized controlled trial comparing CAU plus iCBT-I with CAU in a clinical setting. One hundred ten participants will be referred from the medical doctors in Moscow. Both groups will have access to CAU, which corresponds to the treatment prescribed by the referring doctor. Patients of the first group will additionally get access to the iCBT-I program with the opportunity to contact a specialist (guidance on request) in a secured environment. The primary outcome is insomnia severity change from pre-to post-treatment. Secondary outcomes include change of subjective sleep characteristics, life quality, fatigue, daytime sleepiness, comorbid affective disorders, dysfunctional beliefs about sleep, sleep hygiene, healthcare consumption, productivity losses, and longer term outcomes at 3 months follow-up. Predictor analysis will include baseline scores of the aforementioned outcomes along with treatment expectancies and personality traits. Discussion: The proposed study is one of the first studies evaluating whether iCBT-I also works in routine care. We expect that recruitment of the participants let us determine the target group more precisely and exclude health problems interfering with treatment. Using CAU as control condition may result in a loss of power to detect a meaningful difference.

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Section: Interventionmentioning

confidence: 99%

Section: Primary Outcome Measuresmentioning

confidence: 99%

Section: Sample Size Calculationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Effectiveness and Cost-Effectiveness of Internet-Based Cognitive Behavioral Therapy for Insomnia in Clinical Settings

et al. 2020

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“…A systematic review of trials comparing single-component SRT to waitlist control or sleep hygiene advice found medium-to-large effects on sleep continuity measures 22. Moreover, recent trials suggest SRT may be as effective as multicomponent CBT 23 24. One primary care trial compared brief SRT (delivered by one GP) with sleep hygiene advice 25.…”

Section: Introductionmentioning

confidence: 99%

Primary care treatment of insomnia: study protocol for a pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy to sleep hygiene (the HABIT trial)

et al. 2020

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IntroductionInsomnia is a prevalent sleep disorder that negatively affects quality of life. Multicomponent cognitive-behavioural therapy (CBT) is the recommended treatment but access remains limited, particularly in primary care. Sleep restriction therapy (SRT) is one of the principal active components of CBT and could be delivered by generalist staff in primary care. The aim of this randomised controlled trial is to establish whether nurse-delivered SRT for insomnia disorder is clinically and cost-effective compared with sleep hygiene advice.Methods and analysisIn the HABIT (Health-professional Administered Brief Insomnia Therapy) trial, 588 participants meeting criteria for insomnia disorder will be recruited from primary care in England and randomised (1:1) to either nurse-delivered SRT (plus sleep hygiene booklet) or sleep hygiene booklet on its own. SRT will be delivered over 4 weekly sessions; total therapy time is approximately 1 hour. Outcomes will be collected at baseline, 3, 6 and 12 months post-randomisation. The primary outcome is self-reported insomnia severity using the Insomnia Severity Index at 6 months. Secondary outcomes include health-related and sleep-related quality of life, depressive symptoms, use of prescribed sleep medication, diary and actigraphy-recorded sleep parameters, and work productivity. Analyses will be intention-to-treat. Moderation and mediation analyses will be conducted and a cost-utility analysis and process evaluation will be performed.Ethics and disseminationEthical approval was granted by the Yorkshire and the Humber - Bradford Leeds Research Ethics Committee (reference: 18/YH/0153). We will publish our primary findings in high-impact, peer-reviewed journals. There will be further outputs in relation to process evaluation and secondary analyses focussed on moderation and mediation. Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder.Trial registration numberISRCTN42499563

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Internetbasierte kognitive Verhaltenstherapie der Insomnie und Albtraumstörung

et al. 2019

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A randomized controlled trial comparing guided internet-based multi-component treatment and internet-based guided sleep restriction treatment to care as usual in insomnia

Cited by 23 publications

References 45 publications

Effectiveness and Cost-Effectiveness of Internet-Based Cognitive Behavioral Therapy for Insomnia in Clinical Settings

Effectiveness and Cost-Effectiveness of Internet-Based Cognitive Behavioral Therapy for Insomnia in Clinical Settings

Primary care treatment of insomnia: study protocol for a pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy to sleep hygiene (the HABIT trial)

Internetbasierte kognitive Verhaltenstherapie der Insomnie und Albtraumstörung

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