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Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial
Open accessAbstract
Background In view of the high co-occurrence of depression and insomnia, a novel way to reduce the risk of escalating depression might be to offer an insomnia intervention. We aimed to assess whether an online self-help insomnia program could reduce depression symptoms. Methods We did this randomised controlled trial at the Australian National University in Canberra, Australia. Internet users (aged 18-64 years) with insomnia and depression symptoms, but who did not meet criteria for major depressive disorder, were randomly assigned (1:1), via computer-generated randomisation, to receive SHUTi, a 6 week, modular, online insomnia program based on cognitive behavioural therapy for insomnia, or HealthWatch, an interactive, attention-matched, internet-based placebo control program. Randomisation was stratified by age and sex. Telephone-based interviewers, statisticians, and chief investigators were masked to group allocation. The primary outcome was depression symptoms at 6 months, as measured with the Patient Health Questionnaire (PHQ-9). The primary analysis was by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000121965. Findings Between April 30, 2013, and June 9, 2014, we randomly assigned 1149 participants to receive SHUTi (n=574) or HealthWatch (n=575), of whom 581 (51%) participants completed the study program assessments at 6 weeks and 504 (44%) participants completed 6 months' follow-up. SHUTi significantly lowered depression symptoms on the PHQ-9 at 6 weeks and 6 months compared with HealthWatch (F[degrees of freedom 2,640·1]=37·2, p<0·0001). Major depressive disorder was diagnosed in 22 (4%) participants at 6 months (n=9 in the SHUTi group and n=13 in the HealthWatch group), with no superior effect of SHUTi versus HealthWatch (Fisher's exact test=0·52; p=0·32). No adverse events were reported. Interpretation Online cognitive behaviour therapy for insomnia treatment is a practical and effective way to reduce depression symptoms and could be capable of reducing depression at the population level by use of a fully automatised system with the potential for wide dissemination. Funding Australian National Health and Medical Research Council.
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In the citing paper
“Cognitive behavioral therapy (CBT) can reduce SI and treat depression and insomnia [5].”
From Efficacy of acceptance and commitment therapy in reducing suicidal ideation and deliberate self-harm: Systematic review (2018) · cites this paper as [5]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“Based on a previous RCT conducted by the lead author using a similar social media strategy [31] which recruited an average of 2.8 participants per day”
In the citing paper
“Other strategies such as those addressing maladaptive social cognition exhibit promising results. 468”
From Time for united action on depression: a Lancet–World Psychiatric Association Commission (2022) · cites this paper as [468]
In the citing paper
“In this context, the use of technology 469 (ranging from traditional telephone calls to internet-delivered interventions) to promote social support and a sense of belonging may be a significant help, as well as broader befriending and community inclusion initiatives in the longer term. 468,470”
From Time for united action on depression: a Lancet–World Psychiatric Association Commission (2022) · cites this paper as [468]
In the citing paper
“Sham controls either replaced core treatment activities with “fake, but plausible therapies” (33) or they delivered general, disease agnostic wellbeing tips (32, 56).”
In the citing paper
“For example, in a trial examining SHUTi, a DTx for insomnia, the researchers did not include a sleep window suggestion in their “attention control” (56).”
In the citing paper
“Therefore the investigational treatment and control condition differ on at least these two aspects, and thus the difference between them might be based on core CBT content, the concrete sleep time suggestions, or both (56).”
In the citing paper
“Finally, certain content and/or features were removed in the control condition, mainly disease specific therapeutic content (e.g. CBT (32, 56)) or additional disease management features (community features (33)).”
In the citing paper
“Digital forms of CBT for insomnia that require no therapist to be present have been shown to be efficacious as well.10, 11, 12”
From The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis (2017) · cites this paper as [12]
In the citing paper
“with this figure and pattern almost identical to the most comparable previous study.12”
From The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis (2017) · cites this paper as [12]
In the citing paper
“Fifth, bias in the outcome results will have been introduced because of the high dropout rate, especially in the treatment group, which is similar to comparable online studies.12”
From The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis (2017) · cites this paper as [12]
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“For example, one study found that participants with insomnia and subthreshold depression who receive cognitive behaviour therapy for insomnia had a smaller chance to develop major depression at follow-up (Christensen et al., 2016).”
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Real-world evidence from users of a behavioral digital therapeutic for chronic insomnia
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Metadata
- Authors
- Christensen, H., Batterham, P. J., Gosling, J. A., Ritterband, L. M., Griffiths, K. M., Thorndike, F. P., Glozier, N., O'Dea, B., Hickie, I. B., & Mackinnon, A. J.
- Affiliations
- Black Dog Institute (AU)
- Australian National University (AU)
- University of Virginia (US)
- The University of Sydney (AU)
- The University of Melbourne (AU)
- Corresponding author
- Christensen, Helen
- ORCID
- Venue
- The Lancet Psychiatry
- Publisher
- Elsevier BV
- Published
- 2016-04
- Volume
- 3
- Issue
- 4
- Pages
- 333-341
- ISSN
- 2215-0366 (ISSN-L)
- OpenAlex
- W2268895016
- Cited by
- 365
- References
- 38
- Citations by year
- 2026: 21 · 2025: 33 · 2024: 29 · 2023: 46 · 2022: 37 · 2021: 43 · 2020: 41 · 2019: 34 · 2018: 36 · 2017: 36 · 2016: 8
- FWCI
- 54.10
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Licence
- cc-by-nc-nd
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- Locations
- The Lancet Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- UNSWorks (University of New South Wales, Sydney, Australia) (submittedVersion, cc-by-nc-nd)
- UNSWorks (UNSW Sydney) (submittedVersion, cc-by-nc-nd)
- Funders
- NHMRC (number 1005867, 1056964, 1083311, grant 1059620)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- insomnia, depression prevention, cognitive behavioral therapy for insomnia, online self-help intervention, online intervention, depressive symptoms, major depressive disorder, PHQ-9, digital mental health tools
- MeSH terms
- Adolescent, Adult, Depression, Female, Humans, Sleep Initiation and Maintenance Disorders, Male, Middle Aged, Self-Help Groups, Program Evaluation, Internet, Young Adult
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