Insomnia ChronicDOSENCT05561829

Determination of Optimal Sleep Treatment Elements - MOST

A study testing Sleep Optimization, Relaxation Training and Cognitive Therapy in people with Insomnia Chronic, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Insomnia Chronic
What is being tested?: Sleep Optimization, Relaxation Training and Cognitive Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 489 participants
Where: 1 siteDenmark
Study dates: 8 Sep 2022to 18 May 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults (≥18 years)
Individuals who report moderate-to-severe insomnia symptoms (a score ≥10 on the Insomnia Severity Index, ISI)
Individuals with access to a smartphone or computer with internet connection
Individuals who report sufficient technological proficiency (e.g., ability to download apps)

Who cannot join

Children (<18 years)
Individuals who report mild or no clinically relevant insomnia symptoms (a score <10 on the ISI)
Individuals who have a shift-work schedule or are on maternity/paternity leave, if this impacts their sleep quality or amount of sleep
Individuals who are unable to read Danish
Individuals who report severe physical or psychological comorbidity with known effects on sleep (e.g., psychosis, cardiovascular disease, cancer, COPD)
Individuals who report other diagnosed sleep or circadian rhythm disorders (e.g., sleep apnea, narcolepsy)
Individuals who have previously used the "Hvil®"-app

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Aarhus University
Aarhus, Central Jutland, 8000

Other trials in Denmark

About this study

Official title: Determination of Optimal Sleep Treatment Elements (The DOSE Project)

Previous research has shown the efficacy of (combinations of) individual components of cognitive behavioral therapy for insomnia (CBT-I), namely sleep hygiene education, sleep restriction, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. However, their relative effects, i.e., their effects in direct comparison with each other, are yet to be assessed. By means of the Multiphase Optimization Strategy (MOST), this study aims to investigate the components' relative efficacy in order to identify the most effective component or combination of components for digitized treatment of chronic insomnia. A future study will verify this intervention's effect in a randomized controlled trial (RCT).

Read the detailed description

The DOSE Project employs the Multiphase Optimization Strategy (MOST) to evaluate the relative efficacy of the individual cognitive behavioural therapy for insomnia (CBT-I) components. The present study represents the optimization phase of MOST, which aims to identify which combination of CBT-I components produces the best expected outcome, while taking constraints, such as economy, scalability, treatment complexity, and usability, into account.

The main objectives of the DOSE Project are

To conduct MOST on a multi-component smartphone or web application targeting insomnia
To identify the components and combination of components that demonstrate the best expected obtainable outcome
To examine potential moderators of the effect of the individual treatment components on insomnia severity,
To determine which application build (i.e., combination of components) is optimal to test in a subsequent RCT.

This study employs a fractional factorial experimental design conducted with individuals experiencing moderate-to-severe insomnia. With random allocation, participants will receive a version of the application in which one or more of the five core CBT-I components (i.e., sleep hygiene education, sleep restriction, stimulus control therapy, deactivation/relaxation training, cognitive therapy) are presented in various combinations. The intervention lasts 10 weeks, including an initial one-week assessment period.

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, comparing aggregated groups of N = 2 x 320 (e.g., plus/minus sleep restriction or plus/minus sleep hygiene etc.) on all outcome variables. 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.) influence intervention effects.

Conditions: Insomnia Chronic
Being tested: Sleep Optimization, Stimulus Control Therapy, Relaxation Training, Cognitive Therapy, Sleep Hygiene Education
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sleep OptimizationBehavioural
Automated digital administration of a sleep optimization module via mobile or web application, lasting approximately six weeks. Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to optimise the participant's sleep efficiency.
Stimulus Control TherapyBehavioural
Automated digital administration of a stimulus control therapy module via mobile or web application, lasting approximately six weeks. The aim is to strengthen associations between sleep and the sleep environment and to eliminate conditioning of non-sleep behavior and the sleep environment.
Relaxation TrainingBehavioural
Automated digital administration of a relaxation training module via mobile or web application, lasting approximately six weeks. The aim is to reduce somatic tension and limit intrusive thought processes that interfere with sleep.
Cognitive TherapyBehavioural
Automated digital administration of a cognitive therapy module via mobile or web application, lasting approximately six weeks. The aim is to identify, challenge, and modify dysfunctional beliefs about sleep.
Sleep Hygiene EducationBehavioural
Automated digital administration of a sleep hygiene education module via mobile or web application, lasting approximately six weeks. The aim is to identify and modify environmental and lifestyle factors that may interfere with sleep.

Study groups in NCT05561829
Study group	Role	What they receive
Sleep Hygiene	Experimental	Administration of sleep hygiene education (single intervention) Receives: Behavioral: Sleep Hygiene Education
Cognitive Therapy	Experimental	Administration of cognitive therapy only (single intervention) Receives: Behavioral: Cognitive Therapy
Relaxation Training	Experimental	Administration of relaxation training only (single intervention) Receives: Behavioral: Relaxation Training
Relaxation Training, Cognitive Therapy, Sleep Hygiene	Experimental	Administration of relaxation training, cognitive therapy, and sleep hygiene education (3 interventions) Receives: Behavioral: Relaxation Training; Behavioral: Cognitive Therapy; Behavioral: Sleep Hygiene Education
Stimulus Control	Experimental	Administration of stimulus control therapy only (single intervention) Receives: Behavioral: Stimulus Control Therapy
Stimulus Control, Cognitive Therapy, Sleep Hygiene	Experimental	Administration of stimulus control therapy, cognitive therapy, and sleep hygiene education (3 interventions) Receives: Behavioral: Stimulus Control Therapy; Behavioral: Cognitive Therapy; Behavioral: Sleep Hygiene Education
Stimulus Control, Relaxation Training, Sleep Hygiene	Experimental	Administration of stimulus control therapy, relaxation training, and sleep hygiene education (3 interventions) Receives: Behavioral: Stimulus Control Therapy; Behavioral: Relaxation Training; Behavioral: Sleep Hygiene Education
Stimulus Control, Relaxation Training, Cognitive Therapy	Experimental	Administration of stimulus control therapy, relaxation training, and cognitive therapy (3 interventions) Receives: Behavioral: Stimulus Control Therapy; Behavioral: Relaxation Training; Behavioral: Cognitive Therapy
Sleep Optimization	Experimental	Administration of sleep optimization only (single intervention) Receives: Behavioral: Sleep Optimization
Sleep Optimization, Cognitive Therapy, Sleep Hygiene	Experimental	Administration of sleep optimization, cognitive therapy, and sleep hygiene education (3 interventions) Receives: Behavioral: Sleep Optimization; Behavioral: Cognitive Therapy; Behavioral: Sleep Hygiene Education
Sleep Optimization, Relaxation Training, Sleep Hygiene	Experimental	Administration of sleep optimization, relaxation training, and sleep hygiene education (3 interventions) Receives: Behavioral: Sleep Optimization; Behavioral: Relaxation Training; Behavioral: Sleep Hygiene Education
Sleep Optimization, Relaxation Training, Cognitive Therapy	Experimental	Administration of sleep optimization, relaxation training, and cognitive therapy (3 interventions) Receives: Behavioral: Sleep Optimization; Behavioral: Relaxation Training; Behavioral: Cognitive Therapy
Sleep Optimization, Stimulus Control, Sleep Hygiene	Experimental	Administration of sleep optimization, stimulus control therapy, and sleep hygiene education (3 interventions) Receives: Behavioral: Sleep Optimization; Behavioral: Stimulus Control Therapy; Behavioral: Sleep Hygiene Education
Sleep Optimization, Stimulus Control, Cognitive Therapy	Experimental	Administration of sleep optimization, stimulus control therapy, and cognitive therapy (3 interventions) Receives: Behavioral: Sleep Optimization; Behavioral: Stimulus Control Therapy; Behavioral: Cognitive Therapy
Sleep Optimization, Stimulus Control, Relaxation Training	Experimental	Administration of sleep optimization, stimulus control therapy, and relaxation training (3 interventions) Receives: Behavioral: Sleep Optimization; Behavioral: Stimulus Control Therapy; Behavioral: Relaxation Training
Sleep Optimization, Stimulus Control, Relaxation Training, Cognitive Therapy, Sleep Hygiene	Experimental	Administration of sleep optimization, stimulus control therapy, relaxation training, cognitive therapy, and sleep hygiene education (5 interventions) Receives: Behavioral: Sleep Optimization; Behavioral: Stimulus Control Therapy; Behavioral: Relaxation Training; Behavioral: Cognitive Therapy; Behavioral: Sleep Hygiene Education

What is being measured

The primary outcome is the main question the study is designed to answer.

Insomnia severity post-intervention
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.
Measured: 11 weeks after study entry (randomization)
Insomnia severity at 6 month follow-up
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.
Measured: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).

Secondary outcomes (15)

Sleep diary outcomes post-intervention
Assessed with the Consensus Sleep Diary (CSD), which measures sleep- and waking time, sleep onset latency, wakefulness after initial sleep onset, early morning awakenings, and getting-up time, allowing for total sleep time, total time in bed, and sleep efficiency to be calculated.
Measured: 11 weeks after study entry (randomization)
Sleep diary outcomes at 6-month follow-up
Assessed with the Consensus Sleep Diary (CSD), which measures sleep- and waking time, sleep onset latency, wakefulness after initial sleep onset, early morning awakenings, and getting-up time, allowing for total sleep time, total time in bed, and sleep efficiency to be calculated.
Measured: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Sleep quality post-intervention
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).
Measured: 11 weeks after study entry (randomization)
Sleep quality at 6-month follow-up
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).
Measured: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Daytime fatigue post-intervention
Assessed with the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-Fatigue), which covers physical fatigue, functional fatigue, and social consequences of fatigue.
Measured: 11 weeks after study entry (randomization)
Daytime fatigue at 6-month follow-up
Assessed with the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-Fatigue), which covers physical fatigue, functional fatigue, and social consequences of fatigue.
Measured: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Cognitions about sleep post-intervention
Assessed with the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16).
Measured: 11 weeks after study entry (randomization)
Cognitions about sleep at 6-month follow-up
Assessed with the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16).
Measured: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Physical and mental functioning post-intervention
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.
Measured: 11 weeks after study entry (randomization)
Physical and mental functioning at 6-month follow-up
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.
Measured: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Psychological distress post-intervention
Assessed with the Depression, Anxiety, and Stress Scales-21 (DASS-21), which evaluates the constructs depression, anxiety, and stress on sub-scales.
Measured: 11 weeks after study entry (randomization)
Psychological distress at 6-month follow-up
Assessed with the Depression, Anxiety, and Stress Scales-21 (DASS-21), which evaluates the constructs depression, anxiety, and stress on sub-scales.
Measured: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Health-related well-being post-intervention
Assessed with the 5-item World Health Organisation's Well-Being Index (WHO-5).
Measured: 11 weeks after study entry (randomization)
Health-related well-being at 6-month follow-up
Assessed with the 5-item World Health Organisation's Well-Being Index (WHO-5).
Measured: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Application usability
Assessed with the mHealth App Usability Questionnaire (MAUQ).
Measured: 11 weeks after study entry (randomization)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 202218 May 2024

First posted30 Sep 2022
Study start8 Sep 2022
Primary completion18 May 2024
Study completion18 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (48)Papers the sponsor has linked to this study.
Other trials for Insomnia ChronicStudies of the same condition, open and under way.
More trials run by University of AarhusThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 489 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05561829
Sponsor's protocol ID: 2016-051-000001-2099-2
Acronym: DOSE
Status last verified: May 2025
First submitted: 28 Sep 2022
Last updated: 18 Nov 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

van Straten A, van der Zweerde T, Kleiboer A, Cuijpers P, Morin CM, Lancee J. Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. Sleep Med Rev. 2018 Apr;38:3-16. doi: 10.1016/j.smrv.2017.02.001. Epub 2017 Feb 9.
PubMed 28392168
Morin CM, Benca R. Chronic insomnia. Lancet. 2012 Mar 24;379(9821):1129-41. doi: 10.1016/S0140-6736(11)60750-2. Epub 2012 Jan 20.
PubMed 22265700
Liu TZ, Xu C, Rota M, Cai H, Zhang C, Shi MJ, Yuan RX, Weng H, Meng XY, Kwong JS, Sun X. Sleep duration and risk of all-cause mortality: A flexible, non-linear, meta-regression of 40 prospective cohort studies. Sleep Med Rev. 2017 Apr;32:28-36. doi: 10.1016/j.smrv.2016.02.005. Epub 2016 Mar 3.
PubMed 27067616
Hertenstein E, Feige B, Gmeiner T, Kienzler C, Spiegelhalder K, Johann A, Jansson-Frojmark M, Palagini L, Rucker G, Riemann D, Baglioni C. Insomnia as a predictor of mental disorders: A systematic review and meta-analysis. Sleep Med Rev. 2019 Feb;43:96-105. doi: 10.1016/j.smrv.2018.10.006. Epub 2018 Nov 16.
PubMed 30537570
Virta JJ, Heikkila K, Perola M, Koskenvuo M, Raiha I, Rinne JO, Kaprio J. Midlife sleep characteristics associated with late life cognitive function. Sleep. 2013 Oct 1;36(10):1533-41, 1541A. doi: 10.5665/sleep.3052.
PubMed 24082313
Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.
PubMed 28875581
Daley M, Morin CM, LeBlanc M, Gregoire JP, Savard J. The economic burden of insomnia: direct and indirect costs for individuals with insomnia syndrome, insomnia symptoms, and good sleepers. Sleep. 2009 Jan;32(1):55-64.
PubMed 19189779
Daley M, Morin CM, LeBlanc M, Gregoire JP, Savard J, Baillargeon L. Insomnia and its relationship to health-care utilization, work absenteeism, productivity and accidents. Sleep Med. 2009 Apr;10(4):427-38. doi: 10.1016/j.sleep.2008.04.005. Epub 2008 Aug 26.
PubMed 18753000
Bjorvatn B, Meland E, Flo E, Mildestvedt T. High prevalence of insomnia and hypnotic use in patients visiting their general practitioner. Fam Pract. 2017 Feb;34(1):20-24. doi: 10.1093/fampra/cmw107. Epub 2016 Oct 27.
PubMed 27789518
Riemann D, Perlis ML. The treatments of chronic insomnia: a review of benzodiazepine receptor agonists and psychological and behavioral therapies. Sleep Med Rev. 2009 Jun;13(3):205-14. doi: 10.1016/j.smrv.2008.06.001. Epub 2009 Feb 7.
PubMed 19201632
Kripke DF. Hypnotic drug risks of mortality, infection, depression, and cancer: but lack of benefit. F1000Res. 2016 May 19;5:918. doi: 10.12688/f1000research.8729.3. eCollection 2016.
PubMed 27303633
Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008 Oct 15;4(5):487-504.
PubMed 18853708
Wilson S, Anderson K, Baldwin D, Dijk DJ, Espie A, Espie C, Gringras P, Krystal A, Nutt D, Selsick H, Sharpley A. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: An update. J Psychopharmacol. 2019 Aug;33(8):923-947. doi: 10.1177/0269881119855343. Epub 2019 Jul 4.
PubMed 31271339
Morgenthaler T, Kramer M, Alessi C, Friedman L, Boehlecke B, Brown T, Coleman J, Kapur V, Lee-Chiong T, Owens J, Pancer J, Swick T; American Academy of Sleep Medicine. Practice parameters for the psychological and behavioral treatment of insomnia: an update. An american academy of sleep medicine report. Sleep. 2006 Nov;29(11):1415-9.
PubMed 17162987
Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841.
PubMed 26054060

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia in a Randomized, Controlled, Dose-finding Study
Chronic Insomnia
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effects of Connective Tissue Massage in Patients With Chronic Insomnia
Chronic Insomnia
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Recruiting
Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women
Chronic Insomnia During Perimenopause and Menopause

All Insomnia Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determination of Optimal Sleep Treatment Elements (The DOSE Project)
ClinicalTrials.gov ID: NCT05561829
Acronym / sponsor ID: DOSE / 2016-051-000001-2099-2
Conditions: Insomnia Chronic
Study type: Interventional
Recruitment status: Completed
Enrolment: 489 participants (actual)
Lead sponsor: University of AarhusUniversity, hospital or other
Collaborators: TrygFonden, Denmark, Enversion A/S
Study start: 8 Sep 2022 (actual)
Primary completion: 18 May 2024 (actual)
Study completion: 18 May 2024 (actual)
First posted: 30 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The main objectives of the DOSE Project are

To conduct MOST on a multi-component smartphone or web application targeting insomnia
To identify the components and combination of components that demonstrate the best expected obtainable outcome
To examine potential moderators of the effect of the individual treatment components on insomnia severity,
To determine which application build (i.e., combination of components) is optimal to test in a subsequent RCT.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 16

Arm	Type	Receives
Sleep Hygiene	Experimental	Behavioral: Sleep Hygiene EducationAdministration of sleep hygiene education (single intervention)
Cognitive Therapy	Experimental	Behavioral: Cognitive TherapyAdministration of cognitive therapy only (single intervention)
Relaxation Training	Experimental	Behavioral: Relaxation TrainingAdministration of relaxation training only (single intervention)
Relaxation Training, Cognitive Therapy, Sleep Hygiene	Experimental	Behavioral: Relaxation Training, Behavioral: Cognitive Therapy, Behavioral: Sleep Hygiene EducationAdministration of relaxation training, cognitive therapy, and sleep hygiene education (3 interventions)
Stimulus Control	Experimental	Behavioral: Stimulus Control TherapyAdministration of stimulus control therapy only (single intervention)
Stimulus Control, Cognitive Therapy, Sleep Hygiene	Experimental	Behavioral: Stimulus Control Therapy, Behavioral: Cognitive Therapy, Behavioral: Sleep Hygiene EducationAdministration of stimulus control therapy, cognitive therapy, and sleep hygiene education (3 interventions)
Stimulus Control, Relaxation Training, Sleep Hygiene	Experimental	Behavioral: Stimulus Control Therapy, Behavioral: Relaxation Training, Behavioral: Sleep Hygiene EducationAdministration of stimulus control therapy, relaxation training, and sleep hygiene education (3 interventions)
Stimulus Control, Relaxation Training, Cognitive Therapy	Experimental	Behavioral: Stimulus Control Therapy, Behavioral: Relaxation Training, Behavioral: Cognitive TherapyAdministration of stimulus control therapy, relaxation training, and cognitive therapy (3 interventions)
Sleep Optimization	Experimental	Behavioral: Sleep OptimizationAdministration of sleep optimization only (single intervention)
Sleep Optimization, Cognitive Therapy, Sleep Hygiene	Experimental	Behavioral: Sleep Optimization, Behavioral: Cognitive Therapy, Behavioral: Sleep Hygiene EducationAdministration of sleep optimization, cognitive therapy, and sleep hygiene education (3 interventions)
Sleep Optimization, Relaxation Training, Sleep Hygiene	Experimental	Behavioral: Sleep Optimization, Behavioral: Relaxation Training, Behavioral: Sleep Hygiene EducationAdministration of sleep optimization, relaxation training, and sleep hygiene education (3 interventions)
Sleep Optimization, Relaxation Training, Cognitive Therapy	Experimental	Behavioral: Sleep Optimization, Behavioral: Relaxation Training, Behavioral: Cognitive TherapyAdministration of sleep optimization, relaxation training, and cognitive therapy (3 interventions)
Sleep Optimization, Stimulus Control, Sleep Hygiene	Experimental	Behavioral: Sleep Optimization, Behavioral: Stimulus Control Therapy, Behavioral: Sleep Hygiene EducationAdministration of sleep optimization, stimulus control therapy, and sleep hygiene education (3 interventions)
Sleep Optimization, Stimulus Control, Cognitive Therapy	Experimental	Behavioral: Sleep Optimization, Behavioral: Stimulus Control Therapy, Behavioral: Cognitive TherapyAdministration of sleep optimization, stimulus control therapy, and cognitive therapy (3 interventions)
Sleep Optimization, Stimulus Control, Relaxation Training	Experimental	Behavioral: Sleep Optimization, Behavioral: Stimulus Control Therapy, Behavioral: Relaxation TrainingAdministration of sleep optimization, stimulus control therapy, and relaxation training (3 interventions)
Sleep Optimization, Stimulus Control, Relaxation Training, Cognitive Therapy, Sleep Hygiene	Experimental	Behavioral: Sleep Optimization, Behavioral: Stimulus Control Therapy, Behavioral: Relaxation Training, Behavioral: Cognitive Therapy, Behavioral: Sleep Hygiene EducationAdministration of sleep optimization, stimulus control therapy, relaxation training, cognitive therapy, and sleep hygiene education (5 interventions)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adults (≥18 years)
Individuals who report moderate-to-severe insomnia symptoms (a score ≥10 on the Insomnia Severity Index, ISI)
Individuals with access to a smartphone or computer with internet connection
Individuals who report sufficient technological proficiency (e.g., ability to download apps)

Key exclusion criteria (7 listed)

Children (<18 years)
Individuals who report mild or no clinically relevant insomnia symptoms (a score <10 on the ISI)
Individuals who have a shift-work schedule or are on maternity/paternity leave, if this impacts their sleep quality or amount of sleep
Individuals who are unable to read Danish
Individuals who report severe physical or psychological comorbidity with known effects on sleep (e.g., psychosis, cardiovascular disease, cancer, COPD)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sleep OptimizationAutomated digital administration of a sleep optimization module via mobile or web application, lasting approximately six weeks. Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to optimise the participant's sleep efficiency.	Behavioural	Sleep Optimization, Sleep Optimization, Cognitive Therapy, Sleep Hygiene, Sleep Optimization, Relaxation Training, Cognitive Therapy, Sleep Optimization, Relaxation Training, Sleep Hygiene, Sleep Optimization, Stimulus Control, Cognitive Therapy, Sleep Optimization, Stimulus Control, Relaxation Training, Sleep Optimization, Stimulus Control, Relaxation Training, Cognitive Therapy, Sleep Hygiene, Sleep Optimization, Stimulus Control, Sleep Hygiene
Stimulus Control TherapyAutomated digital administration of a stimulus control therapy module via mobile or web application, lasting approximately six weeks. The aim is to strengthen associations between sleep and the sleep environment and to eliminate conditioning of non-sleep behavior and the sleep environment.	Behavioural	Sleep Optimization, Stimulus Control, Cognitive Therapy, Sleep Optimization, Stimulus Control, Relaxation Training, Sleep Optimization, Stimulus Control, Relaxation Training, Cognitive Therapy, Sleep Hygiene, Sleep Optimization, Stimulus Control, Sleep Hygiene, Stimulus Control, Stimulus Control, Cognitive Therapy, Sleep Hygiene, Stimulus Control, Relaxation Training, Cognitive Therapy, Stimulus Control, Relaxation Training, Sleep Hygiene
Relaxation TrainingAutomated digital administration of a relaxation training module via mobile or web application, lasting approximately six weeks. The aim is to reduce somatic tension and limit intrusive thought processes that interfere with sleep.	Behavioural	Relaxation Training, Relaxation Training, Cognitive Therapy, Sleep Hygiene, Sleep Optimization, Relaxation Training, Cognitive Therapy, Sleep Optimization, Relaxation Training, Sleep Hygiene, Sleep Optimization, Stimulus Control, Relaxation Training, Sleep Optimization, Stimulus Control, Relaxation Training, Cognitive Therapy, Sleep Hygiene, Stimulus Control, Relaxation Training, Cognitive Therapy, Stimulus Control, Relaxation Training, Sleep Hygiene
Cognitive TherapyAutomated digital administration of a cognitive therapy module via mobile or web application, lasting approximately six weeks. The aim is to identify, challenge, and modify dysfunctional beliefs about sleep.	Behavioural	Cognitive Therapy, Relaxation Training, Cognitive Therapy, Sleep Hygiene, Sleep Optimization, Cognitive Therapy, Sleep Hygiene, Sleep Optimization, Relaxation Training, Cognitive Therapy, Sleep Optimization, Stimulus Control, Cognitive Therapy, Sleep Optimization, Stimulus Control, Relaxation Training, Cognitive Therapy, Sleep Hygiene, Stimulus Control, Cognitive Therapy, Sleep Hygiene, Stimulus Control, Relaxation Training, Cognitive Therapy
Sleep Hygiene EducationAutomated digital administration of a sleep hygiene education module via mobile or web application, lasting approximately six weeks. The aim is to identify and modify environmental and lifestyle factors that may interfere with sleep.	Behavioural	Relaxation Training, Cognitive Therapy, Sleep Hygiene, Sleep Hygiene, Sleep Optimization, Cognitive Therapy, Sleep Hygiene, Sleep Optimization, Relaxation Training, Sleep Hygiene, Sleep Optimization, Stimulus Control, Relaxation Training, Cognitive Therapy, Sleep Hygiene, Sleep Optimization, Stimulus Control, Sleep Hygiene, Stimulus Control, Cognitive Therapy, Sleep Hygiene, Stimulus Control, Relaxation Training, Sleep Hygiene

Primary outcome

Insomnia severity post-intervention
Time frame: 11 weeks after study entry (randomization)
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.
Insomnia severity at 6 month follow-up
Time frame: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
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.

15 secondary outcomes

Sleep diary outcomes post-intervention
Time frame: 11 weeks after study entry (randomization)
Sleep diary outcomes at 6-month follow-up
Time frame: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Sleep quality post-intervention
Time frame: 11 weeks after study entry (randomization)
Sleep quality at 6-month follow-up
Time frame: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Daytime fatigue post-intervention
Time frame: 11 weeks after study entry (randomization)
Daytime fatigue at 6-month follow-up
Time frame: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Cognitions about sleep post-intervention
Time frame: 11 weeks after study entry (randomization)
Cognitions about sleep at 6-month follow-up
Time frame: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Physical and mental functioning post-intervention
Time frame: 11 weeks after study entry (randomization)
Physical and mental functioning at 6-month follow-up
Time frame: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Psychological distress post-intervention
Time frame: 11 weeks after study entry (randomization)
Psychological distress at 6-month follow-up
Time frame: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Health-related well-being post-intervention
Time frame: 11 weeks after study entry (randomization)
Health-related well-being at 6-month follow-up
Time frame: 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Application usability
Time frame: 11 weeks after study entry (randomization)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Background: PubMed 28392168van Straten A, van der Zweerde T, Kleiboer A, Cuijpers P, Morin CM, Lancee J. Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. Sleep Med Rev. 2018 Apr;38:3-16. doi: 10.1016/j.smrv.2017.02.001. Epub 2017 Feb 9.
Background: PubMed 22265700Morin CM, Benca R. Chronic insomnia. Lancet. 2012 Mar 24;379(9821):1129-41. doi: 10.1016/S0140-6736(11)60750-2. Epub 2012 Jan 20.
Background: PubMed 27067616Liu TZ, Xu C, Rota M, Cai H, Zhang C, Shi MJ, Yuan RX, Weng H, Meng XY, Kwong JS, Sun X. Sleep duration and risk of all-cause mortality: A flexible, non-linear, meta-regression of 40 prospective cohort studies. Sleep Med Rev. 2017 Apr;32:28-36. doi: 10.1016/j.smrv.2016.02.005. Epub 2016 Mar 3.
Background: PubMed 30537570Hertenstein E, Feige B, Gmeiner T, Kienzler C, Spiegelhalder K, Johann A, Jansson-Frojmark M, Palagini L, Rucker G, Riemann D, Baglioni C. Insomnia as a predictor of mental disorders: A systematic review and meta-analysis. Sleep Med Rev. 2019 Feb;43:96-105. doi: 10.1016/j.smrv.2018.10.006. Epub 2018 Nov 16.
Background: PubMed 24082313Virta JJ, Heikkila K, Perola M, Koskenvuo M, Raiha I, Rinne JO, Kaprio J. Midlife sleep characteristics associated with late life cognitive function. Sleep. 2013 Oct 1;36(10):1533-41, 1541A. doi: 10.5665/sleep.3052.
Background: PubMed 28875581Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.
Background: PubMed 19189779Daley M, Morin CM, LeBlanc M, Gregoire JP, Savard J. The economic burden of insomnia: direct and indirect costs for individuals with insomnia syndrome, insomnia symptoms, and good sleepers. Sleep. 2009 Jan;32(1):55-64.
Background: PubMed 18753000Daley M, Morin CM, LeBlanc M, Gregoire JP, Savard J, Baillargeon L. Insomnia and its relationship to health-care utilization, work absenteeism, productivity and accidents. Sleep Med. 2009 Apr;10(4):427-38. doi: 10.1016/j.sleep.2008.04.005. Epub 2008 Aug 26.
Background: PubMed 27789518Bjorvatn B, Meland E, Flo E, Mildestvedt T. High prevalence of insomnia and hypnotic use in patients visiting their general practitioner. Fam Pract. 2017 Feb;34(1):20-24. doi: 10.1093/fampra/cmw107. Epub 2016 Oct 27.
Background: PubMed 19201632Riemann D, Perlis ML. The treatments of chronic insomnia: a review of benzodiazepine receptor agonists and psychological and behavioral therapies. Sleep Med Rev. 2009 Jun;13(3):205-14. doi: 10.1016/j.smrv.2008.06.001. Epub 2009 Feb 7.
Background: PubMed 27303633Kripke DF. Hypnotic drug risks of mortality, infection, depression, and cancer: but lack of benefit. F1000Res. 2016 May 19;5:918. doi: 10.12688/f1000research.8729.3. eCollection 2016.
Background: PubMed 18853708Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008 Oct 15;4(5):487-504.
Individual participant dataSharing planned: 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.

Related trials for Insomnia Chronic

Not yet recruitingPhase 2
A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia in a Randomized, Controlled, Dose-finding Study
Chronic Insomnia
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effects of Connective Tissue Massage in Patients With Chronic Insomnia
Chronic Insomnia
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Recruiting
Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women
Chronic Insomnia During Perimenopause and Menopause

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Zachariae, DMSc, MSc principal investigator

Aarhus University, Aarhus University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Optimization, Relaxation Training and Cognitive Therapy in people with Insomnia Chronic, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insomnia severity post-intervention (time frame: 11 weeks after study entry (randomization)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05561829, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.