Brief 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. 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

447

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started May 2023

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.6 years study duration

First Submitted

Initial submission to the registry

March 27, 2023

Completed

28 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed

7 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed

Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

March 27, 2023

Last Update Submit

March 10, 2025

Conditions

Insomnia

Keywords

InsomniaICBTFactorial ExperimentOptimizationUser InterfaceAdaptive Treatment StrategyPromptsDigital Intervention

Outcome Measures

Primary Outcomes (2)

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)

Secondary Outcomes (13)

Change in Insomnia symptoms
Change from baseline (right before treatment start) up to 12 months after treatment
Change in Insomnia symptoms
Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Change in Depression symptoms
Change from baseline (right before treatment start) up to 12 months after treatment
Change in Depression symptoms
Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Change in Anxiety symptoms
Change from baseline (right before treatment start) up to 12 months after treatment
+8 more secondary outcomes

Other Outcomes (1)

Clinician time
Immediately after treatment (4 weeks after treatment start)

Study Arms (8)

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).