Insomnia ChronicDOSENCT05561790
Determination of Optimal Sleep Treatment Elements - Pilot
A study testing eCBT-I in people with Insomnia Chronic, run by University of Aarhus at 1 site in Denmark.
Trial summary
Previous research has shown the efficacy of (combinations of) individual components of cognitive behavioral therapy for insomnia (CBT-I), namely sleep hygiene education, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- eCBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Sep 2022to 3 Dec 2022
- 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, e.g., during the beta test phase
Trial locations and contacts
1 site in 1 country.
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 optimization, 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.
In this pilot study, a smartphone and web application developed to treat insomnia using these treatment components will be tested.
Two future studies will investigate the components' relative efficacy in order to identify the most effective component or combination of components for digitized treatment of chronic insomnia by means of the Multiphase Optimization Strategy (MOST), and verify this intervention's effect in a randomized controlled trial (RCT).
Read the detailed description
As a pilot study for a Multiphase Optimization Strategy (MOST) study, the current study will assess the effects of a newly developed smartphone and web application for digitized cognitive behavioural therapy for insomnia (eCBT-I). All treatment components, i.e., sleep hygiene education, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy, will be tested in order to receive feedback on the functioning of the application as well as to get an initial impression of possible treatment effects.
- Conditions
- Insomnia Chronic
- Being tested
- eCBT-I
- 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.
eCBT-IBehavioural
Automated digital administration of sleep hygiene, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy modules via mobile or web application, lasting approximately six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Administration of sleep hygiene, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. Receives: Behavioral: eCBT-I |
| Control | No intervention | Waitlist control (sleep diary only); access to treatment after final measurement |
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)
Secondary outcomes (10)
Sleep diary assessed sleep efficiency (SE) at end of intervention
Based on the Consensus Sleep Diary (CSD) which measures bedtime, rise-time, sleep- and waking time, sleep onset latency, wakefulness after initial sleep onset, allowing for total sleep time, total time in bed, and sleep efficiency to be calculated. SE is calculated as the proportion of time spent asleep out of time spent in bed in percent (TST/TiB*100).
Measured: Approximately 10 weeks after study entry (randomization)
Sleep diary assessed sleep onset latency (SOL) at end of intervention
Assessed with the Consensus Sleep Diary (CSD)
Measured: Approximately 10 weeks after study entry (randomization)
Sleep diary assessed wake after sleep onset (WASO) at end of intervention
Assessed with the Consensus Sleep Diary (CSD)
Measured: Approximately 10 weeks after study entry (randomization)
Sleep diary assessed nocturnal awakenings (NA) at end of intervention
Assessed with the Consensus Sleep Diary (CSD)
Measured: Approximately 10 weeks after study entry (randomization)
Sleep diary assessed total sleep time (TST) at end of intervention
Based on the Consensus Sleep Diary (CSD) which measures bedtime, rise-time, sleep- and waking time, sleep onset latency, wakefulness after initial sleep onset, allowing for total sleep time to be calculated.
Measured: Approximately 10 weeks after study entry (randomization)
Sleep diary assessed time in bed (TiB) at end of intervention
Based on the Consensus Sleep Diary (CSD) which measures bedtime, rise-time, sleep- and waking time, sleep onset latency, wakefulness after initial sleep onset, allowing for time in bed to be calculated.
Measured: Approximately 10 weeks 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)
Cognitions about sleep post-intervention
Assessed with the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16).
Measured: 11 weeks 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)
Usability post-intervention
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.
- First posted30 Sep 2022
- Study start6 Sep 2022
- Primary completion3 Dec 2022
- Study completion3 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark, Enversion A/S
- Responsible party
- Sponsor
- Investigators
- Robert Zachariae, DMSc, MSc, Principal investigator, Aarhus University, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561790
- Sponsor's protocol ID
- 2016-051-000001-2099-1
- Acronym
- DOSE
- Status last verified
- Sep 2022
- First submitted
- 28 Sep 2022
- Last updated
- 14 Sep 2023
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. 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
- NCT05561790
- Acronym / sponsor ID
- DOSE / 2016-051-000001-2099-1
- Conditions
- Insomnia Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark, Enversion A/S
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 3 Dec 2022 (actual)
- Study completion
- 3 Dec 2022 (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.
Previous research has shown the efficacy of (combinations of) individual components of cognitive behavioral therapy for insomnia (CBT-I), namely sleep hygiene education, sleep optimization, 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.
In this pilot study, a smartphone and web application developed to treat insomnia using these treatment components will be tested.
Two future studies will investigate the components' relative efficacy in order to identify the most effective component or combination of components for digitized treatment of chronic insomnia by means of the Multiphase Optimization Strategy (MOST), and verify this intervention's effect in a randomized controlled trial (RCT).
Detailed description
As a pilot study for a Multiphase Optimization Strategy (MOST) study, the current study will assess the effects of a newly developed smartphone and web application for digitized cognitive behavioural therapy for insomnia (eCBT-I). All treatment components, i.e., sleep hygiene education, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy, will be tested in order to receive feedback on the functioning of the application as well as to get an initial impression of possible treatment effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: eCBT-IAdministration of sleep hygiene, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. |
| Control | No intervention | –Waitlist control (sleep diary only); access to treatment after final measurement |
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 |
|---|---|---|
| eCBT-IAutomated digital administration of sleep hygiene, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy modules via mobile or web application, lasting approximately six weeks. | Behavioural | Intervention |
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.
10 secondary outcomes
Sleep diary assessed sleep efficiency (SE) at end of intervention
Time frame: Approximately 10 weeks after study entry (randomization)
Sleep diary assessed sleep onset latency (SOL) at end of intervention
Time frame: Approximately 10 weeks after study entry (randomization)
Sleep diary assessed wake after sleep onset (WASO) at end of intervention
Time frame: Approximately 10 weeks after study entry (randomization)
Sleep diary assessed nocturnal awakenings (NA) at end of intervention
Time frame: Approximately 10 weeks after study entry (randomization)
Sleep diary assessed total sleep time (TST) at end of intervention
Time frame: Approximately 10 weeks after study entry (randomization)
Sleep diary assessed time in bed (TiB) at end of intervention
Time frame: Approximately 10 weeks after study entry (randomization)
Daytime fatigue post-intervention
Time frame: 11 weeks after study entry (randomization)
Cognitions about sleep post-intervention
Time frame: 11 weeks after study entry (randomization)
Psychological distress post-intervention
Time frame: 11 weeks after study entry (randomization)
Usability post-intervention
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 14 Sep 2023.
- 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.
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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 eCBT-I 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 14 Sep 2023. 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2023.