CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 447 enrolled
Drug / intervention
Digital self-guided psychological intervention for insomniabehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05826002
NCT05826002N/ACompleted

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

Karolinska Institutet·interventional·Posted Apr 24, 2023·Updated Mar 12, 2025

In Brief

A clinical study evaluating Digital self-guided psychological intervention for insomnia for Insomnia. Completed, enrolled 447 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesSweden
CollaboratorsRegion Stockholm

Timeline

N/ACompletedFinished
202420252026
First PostedApr 24, 2023
Enrollment StartMay 1, 2023
Primary CompletionDec 15, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 3.2 years ago

Interventions

Digital self-guided psychological intervention for insomniabehavioral

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.