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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| 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). |
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| 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). |
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| Digital insomnia intervention + daily prompts |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital self-guided psychological intervention for insomnia | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement with intervention method | Treatment engagement questionnaire (self-rated study-specific questionnaire), score range 0-21 (0-7 per item), higher is better | 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 | Immediately after treatment (4 weeks after treatment start) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insomnia symptoms | Insomnia Severity Index (self-rated), score range 0-28, lower is better | Change from baseline (right before treatment start) up to 12 months after treatment |
| Change in Insomnia symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician time | Time in minutes the clinician spends on the participant giving guidance through telephone calls and/or written guidance, in minutes, lower is better | Immediately after treatment (4 weeks after treatment start) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Psychiatry Research | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40628992 | Derived | 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. |
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IPD available anonymized on reasonable request.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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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.
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Participants will be blinded to what condition they are randomized to, and will not receive information concerning what features are being manipulated in the experiment.
| Active Comparator |
This 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 | This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (no), daily prompts (yes). |
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| 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). |
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| 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). |
|
Insomnia Severity Index (self-rated), score range 0-28, lower is better
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 2 weeks after treatment start (mid-treatment) |
| Intervention/system usability | System Usability Scale (self-rated), score range 0-100, higher is better | 2 weeks after treatment start (mid-treatment) |
| Treatment satisfaction | Client Satisfaction Questionnaire-8 (self-rated), score range 8-32, higher is better | Immediately after treatment (4 weeks after treatment start) |
| D001523 |
| Mental Disorders |