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

Not Applicable

Completed

• Conditions: Insomnia

• Registration Number: NCT05826002
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-24
• Study Start: 2023-05-01
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 447

Inclusion Criteria

1. ≥ 18 years of age.
2. ≥ 15 points on Insomnia Severity Index.
3. Insomnia diagnosis, according to criteria in the Diagnostic and Statistical Manual of mental disorders-5 (somatic/psychiatric comorbidity is allowed).
4. Good understanding of the Swedish language.
5. No practical obstacles to participate in treatment and assessments.
6. Daily access to computer/smart-phone/tablet with Internet access.
7. Can receive phone calls and text messages during the study period.

Exclusion Criteria

1. Sleep diseases, such as narcolepsy or sleep apnea.
2. Somatic or psychiatric illnesses that either are directly contraindicated for the treatment, require other treatment, or entail symptoms/a functional level making it too difficult to participate in the study.
3. Alcohol/drug abuse, or medication with side effects on sleep (however, sleep medication is allowed).
4. Working nights or night shifts.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Engagement with intervention method	Immediately after treatment (4 weeks after treatment start)	Treatment engagement questionnaire (self-rated study-specific questionnaire), score range 0-21 (0-7 per item), higher is better

Secondary Outcome Measures

Name	Time	Method
Change in Insomnia symptoms	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)	Insomnia Severity Index (self-rated), score range 0-28, lower is better
Change in Depression symptoms	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)	Patient Health Questionnaire-9 (self-rated), score range 0-27, lower is better
Change in Anxiety symptoms	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)	Generalized Anxiety Disorder-7 (self-rated), score range 0-21, lower is better
Change in Life quality	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)	Brunnsviken Brief Quality of life scale (self-rated), score range 0-96, higher is better
Treatment credibility	2 weeks after treatment start (mid-treatment)	Credibility/Expectancy Questionnaire (self-rated), score range 0-50, higher is better
Intervention/system usability	2 weeks after treatment start (mid-treatment)	System Usability Scale (self-rated), score range 0-100, higher is better
Change in Daily function	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)	World Health Organization Disability Assessment Schedule (self-rated), score rang 0-100, lower is better
Treatment satisfaction	Immediately after treatment (4 weeks after treatment start)	Client Satisfaction Questionnaire-8 (self-rated), score range 8-32, higher is better

Trial Locations

Locations (1)

Centre for Psychiatry Research; 🇸🇪 Stockholm, Sweden