NCT05826002

Optimization of a Digital Self-guided Psychological Intervention for Insomnia: A Randomized Factorial Experiment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 447 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-12-15
• Completion: 2024-12-15
• First posted: 2023-04-24
• Last updated: 2025-03-12

Locations

1 site across 1 country: Sweden