An interventional study of Digitally delivered CBTI (eCBTI) in Insomnia Chronic, sponsored by Aarhus University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by Aarhus University Hospital · Not applicable, Interventional, and Treatment
Insomnia is a widespread public health challenge considering its impact on daily life, comorbidity with other disorders, and socio-economic costs. Previous research has shown the efficacy of cognitive behavioral therapy for insomnia (CBTI), and recent research indicates that digitally delivered CBTI (eCBTI) is highly efficacious, and statistically significantly equivalent to in-person delivered CBTI (ipCBTI) for treating insomnia. However, research is limited as to how eCBTI can be integrated into general practice as a non-pharmacological alternative to hypnotics. This study aims to evaluate the feasibility, acceptability, and effectiveness of a fully automated mobile application for treating insomnia in general practice. The secondary aims are to examine effects on psychological and physical comorbidities, possible moderators and mediators of the effect of eCBTI, and cost-effectiveness.
Insomnia is prevalent in the general population (10%) and particularly so among patients in general practice (30-50%), with considerable costs to the individual and society. Hypnotics, which remain the most common treatment option in general practice, are usually not curative and are associated with risks of side effects, dependence, tolerance, and increased mortality. In contrast, cognitive behavioral therapy for insomnia (CBTI) has been shown to be highly efficacious and is recommended as the first-line treatment for insomnia by organizations such as the American Academy of Sleep Medicine, the American College of Physicians, and the European Sleep Research Society.
However, the challenge remains to make CBTI available to meet population needs due to several barriers, including a limited number of trained therapists, the costs of delivering CBTI face-to-face, and physical and geographical constraints. Digitally delivered CBTI (eCBTI) has been shown to be a possible approach to overcoming these challenges, but research on the effectiveness of eCBTI in a general practice setting remains limited.
Given the current lack of non-pharmacological treatment options for insomnia in general practice and the considerable potential of eCBTI to treat insomnia, the primary aim of the proposed study is to evaluate the feasibility, acceptability, and short- and longer-term efficacy of eCBTI for the treatment of insomnia in general practice. Our secondary aims are: a) to evaluate the possible benefits of treating insomnia on psychological and physical symptoms and comorbidities, b) to explore for whom the intervention works by examining the possible moderating effects of information technology proficiency and socio-demographic, clinical, and work-related factors, c) to investigate the possible working mechanisms, including changes in sleep-related cognitions and behaviors, and d) to assess the cost-effectiveness of the intervention.
The study is designed as a cluster-randomized controlled trial, randomizing general practitioners (GPs) from three Danish regions to screen patients for insomnia and offer either hvil®, a mobile-based program for delivering CBTI (eCBTI), or care as usual to those with moderate to-severe insomnia (ISI ≥ 10). A total of 2 X 50 GPs are expected to recruit a minimum of 2 X 250 patients who will complete the intervention. The intervention lasts 10 weeks, including an initial one-week assessment period.
The primary outcome is insomnia severity, assessed with the Insomnia Severity Index (ISI). Secondary sleep diary-based outcomes include sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TiB), and sleep efficiency (SE). Secondary non-sleep outcomes include quality-of-life (QoL) and psychological and physical symptoms such as anxiety, depression, fatigue, and pain. Cost-effectiveness will be assessed using data on healthcare utilization, social benefits, and employment from Danish national registries. Outcomes will be assessed at baseline (week 0) (T1), halfway through the intervention (week 5), post-intervention (week 11) (T3), and follow-up (6 months) (T4).
Baseline group differences (concerning socio-demographic, disease-related, and psychosocial data) will be explored to test the success of the randomization. If differences are found, sensitivity analyses will be made to evaluate their possible influence on the results. Main effects will be analysed using Mixed Linear Models (MLMs) based on the intent-to-treat sample. MLMs account for the hierarchical, non-independent nature of the data (i.e., repeated measures nested within patients and treatment conditions), testing the time*group interaction effect, reflecting the effect of treatment. Moderation analyses will evaluate whether individual differences in various baseline variables (e.g., physical function, expectations, computer proficiency, chronotype, etc.) or treatment adherence influence intervention effects.
Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Waitlist control; care as usual coupled with generic sleep hygiene advice. Access to treatment provided after final measurement.
Based on the existing consensus concerning non-pharmacological treatment of insomnia, Hvil® includes the following treatment components: sleep hygiene, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. Intervention duration is approximately six to nine weeks.
Behavioral: Digitally delivered CBTI (eCBTI)
Based on the existing consensus concerning non-pharmacological treatment of insomnia, Hvil® includes the following treatment components: sleep hygiene, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. Intervention duration is approximately six to nine weeks.
Insomnia severity
Assessed with the Insomnia Severity Index (ISI), with scores ranging from 0 to 28, where higher scores indicate higher insomnia severity, and a score equal to or above 10 indicates clinical significance.
Time frame: Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
Sleep diary outcomes
Assessed with the Consensus Sleep Diary (CSD), which measures sleep- and waking time, sleep onset latency (SOL), wakefulness after initial sleep onset (WASO), early morning awakenings (EMA), and risetime, allowing for total sleep time (TST), total time in bed (TIB), and sleep efficiency (SE) to be calculated.
Time frame: Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
Sleep quality
Assessed with the Pittsburgh sleep quality index (PSQI), which measures clinically derived domains of sleep difficulties (i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction).
Time frame: Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
Daytime fatigue
Assessed with the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-Fatigue), which covers physical fatigue, functional fatigue, and social consequences of fatigue.
Time frame: Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
Cognitions about sleep
Assessed with the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16).
Time frame: Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
Physical and mental functioning
Assessed with the Short Form Health Survey (SF-12), which addresses different aspects of emotional states and daily activities. The questionnaire allows for sub-scores for mental and physical health to be calculated based on population norms, with higher scores indicating better health
Time frame: Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
Psychological distress
Assessed with the Depression, Anxiety, and Stress Scales-21 (DASS-21), which evaluates the constructs depression, anxiety, and stress on sub-scales.
Time frame: Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
Health-related well-being
Assessed with the 5-item World Health Organisation\'s Well-Being Index (WHO-5).
Time frame: Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
Application usability
Assessed with the short version of the mHealth App Usability Questionnaire (MAUQ-S).
Time frame: Post-treatment (approximately week 11)
Health-related quality of life
Assessed with the five-dimensional EuroQol (EQ-5D-5L), which measures self-reported health and well-being across five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, as well as overall health on a 0-100 VAS. A higher score indicates better quality of life.
Time frame: Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
Socio-economic costs
Assessed with data from Danish national registers on redeemed medicine prescriptions, use of primary and secondary health care services, long-term sickness absence
Time frame: Throughout the study period, from study enrollment (week 0) to follow-up at 37 weeks
Plan to share: Yes — All individual participant data collected during the study will be made available in an irreversibly anonymized form. However, only data of those participants can be shared who have explicitly given consent to this as part of their informed consent to study participation. This means that it may not be possible to share all data underlying a certain publication. Data will be shared exclusively for research purposes.
Supporting information: Study protocol, Sap, Icf
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