An interventional study of Digital self-guided psychological intervention for insomnia in Insomnia, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 447 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (no), daily prompts (no).
Behavioral: Digital self-guided psychological intervention for insomnia
This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (no), daily prompts (no).
Behavioral: Digital self-guided psychological intervention for insomnia
This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (yes), daily prompts (no).
Behavioral: Digital self-guided psychological intervention for insomnia
This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (yes), daily prompts (no).
Behavioral: Digital self-guided psychological intervention for insomnia
This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (no), daily prompts (yes).
Behavioral: Digital self-guided psychological intervention for insomnia
This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (no), daily prompts (yes).
Behavioral: Digital self-guided psychological intervention for insomnia
This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (yes), daily prompts (yes).
Behavioral: Digital self-guided psychological intervention for insomnia
This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (yes), daily prompts (yes).
Behavioral: Digital self-guided psychological intervention for insomnia
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.
Engagement with intervention method
Treatment engagement questionnaire (self-rated study-specific questionnaire), score range 0-21 (0-7 per item), higher is better
Time frame: 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
Time frame: Immediately after treatment (4 weeks after treatment start)
Change in Insomnia symptoms
Insomnia Severity Index (self-rated), score range 0-28, lower is better
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 weeks after treatment start (mid-treatment)
Intervention/system usability
System Usability Scale (self-rated), score range 0-100, higher is better
Time frame: 2 weeks after treatment start (mid-treatment)
Treatment satisfaction
Client Satisfaction Questionnaire-8 (self-rated), score range 8-32, higher is better
Time frame: Immediately after treatment (4 weeks after treatment start)
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
Time frame: Immediately after treatment (4 weeks after treatment start)
Plan to share: Undecided — IPD available anonymized on reasonable request.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet