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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

447 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-12-15

Brief Summary

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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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Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Digital insomnia intervention

This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (no), daily prompts (no).

Group Type ACTIVE_COMPARATOR