InsomniaNCT05826002
Optimization of a Digital Self-guided Psychological Intervention for Insomnia: A Randomized Factorial Experiment
A study testing Digital self-guided psychological intervention for insomnia in people with Insomnia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
In a previous pilot study, a digital self-guided intervention for insomnia showed preliminary positive effects on insomnia symptoms. In order to optimize the digital self-guided format, this study will evaluate the added value of three treatment features on treatment engagement and insomnia symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Digital self-guided psychological intervention for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2023to 15 Dec 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
- ≥ 18 years of age.
- ≥ 15 points on Insomnia Severity Index.
- Insomnia diagnosis, according to criteria in the Diagnostic and Statistical Manual of mental disorders-5 (somatic/psychiatric comorbidity is allowed).
- Good understanding of the Swedish language.
- No practical obstacles to participate in treatment and assessments.
- Daily access to computer/smart-phone/tablet with Internet access.
- Can receive phone calls and text messages during the study period.
Who cannot join
- Sleep diseases, such as narcolepsy or sleep apnea.
- Somatic or psychiatric illnesses that either are directly contraindicated for the treatment, require other treatment, or entail symptoms/a functional level making it too difficult to participate in the study.
- Alcohol/drug abuse, or medication with side effects on sleep (however, sleep medication is allowed).
- Working nights or night shifts.
Trial locations and contacts
1 site in 1 country.
About this study
In a previous pilot study, a digital self-guided intervention for insomnia showed preliminary positive effects on insomnia symptoms. In order to optimize the digital self-guided format, this study will evaluate the added value of three treatment features on treatment engagement and insomnia symptoms. The participants will be adults with insomnia. The trial will be a 2x2x2 randomized factorial experiment, where the following features/factors will be manipulated: an optimized graphical user interface (yes or no), an adaptive treatment strategy (yes or no), and daily prompts to use the intervention (yes or no). The factorial experiment will create 8 equally large groups (1:1:1:1:1:1:1:1), who will receive the different combinations of features. The main outcome will be the effect on treatment engagement.
- Conditions
- Insomnia
- Being tested
- Digital self-guided psychological intervention for insomnia
- Keywords
- Insomnia, ICBT, Factorial Experiment, Optimization, User Interface, Adaptive Treatment Strategy, Prompts, Digital Intervention
- 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.
Digital self-guided psychological intervention for insomniaBehavioural
A four week digital self-guided intervention for insomnia, with content derived from Cognitive Behavioral Therapy for insomnia, and with a clinical interview before and after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Digital insomnia intervention | Active comparator | This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (no), daily prompts (no). Receives: Behavioral: Digital self-guided psychological intervention for insomnia |
| Digital insomnia intervention + optimized user interface | Active comparator | This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (no), daily prompts (no). Receives: Behavioral: Digital self-guided psychological intervention for insomnia |
| Digital insomnia intervention + adaptive treatment strategy | Active comparator | This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (yes), daily prompts (no). Receives: Behavioral: Digital self-guided psychological intervention for insomnia |
| Digital insomnia intervention + optimized user interface, adaptive treatment strategy | Active comparator | This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (yes), daily prompts (no). Receives: Behavioral: Digital self-guided psychological intervention for insomnia |
| Digital insomnia intervention + daily prompts | Active comparator | This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (no), daily prompts (yes). Receives: Behavioral: Digital self-guided psychological intervention for insomnia |
| Digital insomnia intervention + optimized user interface, daily prompts | Active comparator | This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (no), daily prompts (yes). Receives: Behavioral: Digital self-guided psychological intervention for insomnia |
| Digital insomnia intervention + adaptive treatment strategy, daily prompts | Active comparator | This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (yes), daily prompts (yes). Receives: Behavioral: Digital self-guided psychological intervention for insomnia |
| Digital insomnia intervention + optimized user interface, adaptive treatment strategy, daily prompts | Active comparator | This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (yes), daily prompts (yes). Receives: Behavioral: Digital self-guided psychological intervention for insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement with intervention method
Treatment engagement questionnaire (self-rated study-specific questionnaire), score range 0-21 (0-7 per item), higher is better
Measured: Up to 12 months after treatment
Engagement with intervention method
Treatment engagement questionnaire (self-rated study-specific questionnaire), score range 0-21 (0-7 per item), higher is better
Measured: Immediately after treatment (4 weeks after treatment start)
Secondary outcomes (13)
Change in Insomnia symptoms
Insomnia Severity Index (self-rated), score range 0-28, lower is better
Measured: Change from baseline (right before treatment start) up to 12 months after treatment
Change in Insomnia symptoms
Insomnia Severity Index (self-rated), score range 0-28, lower is better
Measured: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Change in Depression symptoms
Patient Health Questionnaire-9 (self-rated), score range 0-27, lower is better
Measured: Change from baseline (right before treatment start) up to 12 months after treatment
Change in Depression symptoms
Patient Health Questionnaire-9 (self-rated), score range 0-27, lower is better
Measured: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Change in Anxiety symptoms
Generalized Anxiety Disorder-7 (self-rated), score range 0-21, lower is better
Measured: Change from baseline (right before treatment start) up to 12 months after treatment
Change in Anxiety symptoms
Generalized Anxiety Disorder-7 (self-rated), score range 0-21, lower is better
Measured: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Change in Life quality
Brunnsviken Brief Quality of life scale (self-rated), score range 0-96, higher is better
Measured: Change from baseline (right before treatment start) up to 12 months after treatment
Change in Life quality
Brunnsviken Brief Quality of life scale (self-rated), score range 0-96, higher is better
Measured: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Change in Daily function
World Health Organization Disability Assessment Schedule (self-rated), score rang 0-100, lower is better
Measured: Change from baseline (right before treatment start) up to 12 months after treatment
Change in Daily function
World Health Organization Disability Assessment Schedule (self-rated), score rang 0-100, lower is better
Measured: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Treatment credibility
Credibility/Expectancy Questionnaire (self-rated), score range 0-50, higher is better
Measured: 2 weeks after treatment start (mid-treatment)
Intervention/system usability
System Usability Scale (self-rated), score range 0-100, higher is better
Measured: 2 weeks after treatment start (mid-treatment)
Treatment satisfaction
Client Satisfaction Questionnaire-8 (self-rated), score range 8-32, higher is better
Measured: Immediately after treatment (4 weeks after treatment start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 May 2023
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Model description
- A 2x2x2 randomized factorial experiment, where adult participants with insomnia get to use a digital self-guided intervention for insomnia. Three factors/treatment features will be manipulated in the experiment, namely: 1) an optimized graphical user interface (yes or no), 2) an adaptive treatment strategy (yes or no), and 3) daily prompts to use the intervention (yes or no). The factorial experiment will create 8 equally large groups (1:1:1:1:1:1:1:1), who will receive the different combinations of features.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Martin Kraepelien, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826002
- Sponsor's protocol ID
- 2022-07226-01
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD available anonymized on reasonable request.
Publications
Hentati A, Hentati Isacsson N, Rosen A, Jernelov S, Kaldo V, Ljotsson B, Forsell E, Lindefors N, Kraepelien M. Effects of intervention design on engagement and outcomes in digital self-help for insomnia - factorial RCT. NPJ Digit Med. 2025 Jul 8;8(1):416. doi: 10.1038/s41746-025-01839-0.
PubMed 40628992
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of a Digital Self-guided Psychological Intervention for Insomnia: A Randomized Factorial Experiment
- ClinicalTrials.gov ID
- NCT05826002
- Acronym / sponsor ID
- 2022-07226-01
- Conditions
- Insomnia
- Keywords
- Insomnia, ICBT, Factorial Experiment, Optimization, User Interface, Adaptive Treatment Strategy, Prompts, Digital Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 May 2023 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 24 Apr 2023 (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.
In a previous pilot study, a digital self-guided intervention for insomnia showed preliminary positive effects on insomnia symptoms. In order to optimize the digital self-guided format, this study will evaluate the added value of three treatment features on treatment engagement and insomnia symptoms. The participants will be adults with insomnia. The trial will be a 2x2x2 randomized factorial experiment, where the following features/factors will be manipulated: an optimized graphical user interface (yes or no), an adaptive treatment strategy (yes or no), and daily prompts to use the intervention (yes or no). The factorial experiment will create 8 equally large groups (1:1:1:1:1:1:1:1), who will receive the different combinations of features. The main outcome will be the effect on treatment engagement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
- Model description
- A 2x2x2 randomized factorial experiment, where adult participants with insomnia get to use a digital self-guided intervention for insomnia. Three factors/treatment features will be manipulated in the experiment, namely: 1) an optimized graphical user interface (yes or no), 2) an adaptive treatment strategy (yes or no), and 3) daily prompts to use the intervention (yes or no). The factorial experiment will create 8 equally large groups (1:1:1:1:1:1:1:1), who will receive the different combinations of features.
| Arm | Type | Receives |
|---|---|---|
| Digital insomnia intervention | Active comparator | Behavioral: Digital self-guided psychological intervention for insomniaThis group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (no), daily prompts (no). |
| Digital insomnia intervention + optimized user interface | Active comparator | Behavioral: Digital self-guided psychological intervention for insomniaThis group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (no), daily prompts (no). |
| Digital insomnia intervention + adaptive treatment strategy | Active comparator | Behavioral: Digital self-guided psychological intervention for insomniaThis group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (yes), daily prompts (no). |
| Digital insomnia intervention + optimized user interface, adaptive treatment strategy | Active comparator | Behavioral: Digital self-guided psychological intervention for insomniaThis group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (yes), daily prompts (no). |
| Digital insomnia intervention + daily prompts | Active comparator | Behavioral: Digital self-guided psychological intervention for insomniaThis group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (no), daily prompts (yes). |
| Digital insomnia intervention + optimized user interface, daily prompts | Active comparator | Behavioral: Digital self-guided psychological intervention for insomniaThis group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (no), daily prompts (yes). |
| Digital insomnia intervention + adaptive treatment strategy, daily prompts | Active comparator | Behavioral: Digital self-guided psychological intervention for insomniaThis group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (yes), daily prompts (yes). |
| Digital insomnia intervention + optimized user interface, adaptive treatment strategy, daily prompts | Active comparator | Behavioral: Digital self-guided psychological intervention for insomniaThis group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (yes), daily prompts (yes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age.
- ≥ 15 points on Insomnia Severity Index.
- Insomnia diagnosis, according to criteria in the Diagnostic and Statistical Manual of mental disorders-5 (somatic/psychiatric comorbidity is allowed).
- Good understanding of the Swedish language.
- No practical obstacles to participate in treatment and assessments.
Key exclusion criteria (4 listed)
- Sleep diseases, such as narcolepsy or sleep apnea.
- Somatic or psychiatric illnesses that either are directly contraindicated for the treatment, require other treatment, or entail symptoms/a functional level making it too difficult to participate in the study.
- Alcohol/drug abuse, or medication with side effects on sleep (however, sleep medication is allowed).
- Working nights or night shifts.
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 |
|---|---|---|
| Digital self-guided psychological intervention for insomniaA four week digital self-guided intervention for insomnia, with content derived from Cognitive Behavioral Therapy for insomnia, and with a clinical interview before and after the intervention. | Behavioural | Digital insomnia intervention, Digital insomnia intervention + adaptive treatment strategy, Digital insomnia intervention + adaptive treatment strategy, daily prompts, Digital insomnia intervention + daily prompts, Digital insomnia intervention + optimized user interface, Digital insomnia intervention + optimized user interface, adaptive treatment strategy, Digital insomnia intervention + optimized user interface, adaptive treatment strategy, daily prompts, Digital insomnia intervention + optimized user interface, daily prompts |
Primary outcome
Engagement with intervention method
Time frame: Up to 12 months after treatment
Treatment engagement questionnaire (self-rated study-specific questionnaire), score range 0-21 (0-7 per item), higher is better
Engagement with intervention method
Time frame: Immediately after treatment (4 weeks after treatment start)
Treatment engagement questionnaire (self-rated study-specific questionnaire), score range 0-21 (0-7 per item), higher is better
13 secondary outcomes
Change in Insomnia symptoms
Time frame: Change from baseline (right before treatment start) up to 12 months after treatment
Change in Insomnia symptoms
Time frame: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Change in Depression symptoms
Time frame: Change from baseline (right before treatment start) up to 12 months after treatment
Change in Depression symptoms
Time frame: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Change in Anxiety symptoms
Time frame: Change from baseline (right before treatment start) up to 12 months after treatment
Change in Anxiety symptoms
Time frame: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Change in Life quality
Time frame: Change from baseline (right before treatment start) up to 12 months after treatment
Change in Life quality
Time frame: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Change in Daily function
Time frame: Change from baseline (right before treatment start) up to 12 months after treatment
Change in Daily function
Time frame: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Treatment credibility
Time frame: 2 weeks after treatment start (mid-treatment)
Intervention/system usability
Time frame: 2 weeks after treatment start (mid-treatment)
Treatment satisfaction
Time frame: Immediately after treatment (4 weeks after treatment start)
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 12 Mar 2025.
- Derived from this study: PubMed 40628992Hentati A, Hentati Isacsson N, Rosen A, Jernelov S, Kaldo V, Ljotsson B, Forsell E, Lindefors N, Kraepelien M. Effects of intervention design on engagement and outcomes in digital self-help for insomnia - factorial RCT. NPJ Digit Med. 2025 Jul 8;8(1):416. doi: 10.1038/s41746-025-01839-0.
- Individual participant dataSharing planned: Undecided. IPD available anonymized on reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital self-guided psychological intervention for insomnia in people with Insomnia, run by Karolinska Institutet at 1 site in Sweden.
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 7 inclusion and 4 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 12 Mar 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 Sweden. 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?
Engagement with intervention method (time frame: Up to 12 months after treatment). 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 NCT05826002, which also lists 1 linked publication.
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 12 Mar 2025.