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

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 Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Digital self-guided psychological intervention for insomnia

• Study Type: Interventional
• Enrollment (Actual): 447
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Centre for Psychiatry Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Digital insomnia intervention; This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (no), daily prompts (no).	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.
Active Comparator: Digital insomnia intervention + optimized user interface; This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (no), daily prompts (no).	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.
Active Comparator: Digital insomnia intervention + adaptive treatment strategy; This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (yes), daily prompts (no).	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.
Active Comparator: Digital insomnia intervention + optimized user interface, adaptive treatment strategy; This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (yes), daily prompts (no).	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.
Active Comparator: Digital insomnia intervention + daily prompts; This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (no), daily prompts (yes).	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.
Active Comparator: Digital insomnia intervention + optimized user interface, daily prompts; This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (no), daily prompts (yes).	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.
Active Comparator: Digital insomnia intervention + adaptive treatment strategy, daily prompts; This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (yes), daily prompts (yes).	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.
Active Comparator: Digital insomnia intervention + optimized user interface, adaptive treatment strategy, daily prompts; This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (yes), daily prompts (yes).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Insomnia symptoms	Insomnia Severity Index (self-rated), score range 0-28, lower is better	Change from baseline (right before treatment start) up to 12 months after treatment
Change in Insomnia symptoms	Insomnia Severity Index (self-rated), score range 0-28, lower is better	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Change in Depression symptoms	Patient Health Questionnaire-9 (self-rated), score range 0-27, lower is better	Change from baseline (right before treatment start) up to 12 months after treatment
Change in Depression symptoms	Patient Health Questionnaire-9 (self-rated), score range 0-27, lower is better	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Change in Anxiety symptoms	Generalized Anxiety Disorder-7 (self-rated), score range 0-21, lower is better	Change from baseline (right before treatment start) up to 12 months after treatment
Change in Anxiety symptoms	Generalized Anxiety Disorder-7 (self-rated), score range 0-21, lower is better	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Change in Life quality	Brunnsviken Brief Quality of life scale (self-rated), score range 0-96, higher is better	Change from baseline (right before treatment start) up to 12 months after treatment
Change in Life quality	Brunnsviken Brief Quality of life scale (self-rated), score range 0-96, higher is better	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Change in Daily function	World Health Organization Disability Assessment Schedule (self-rated), score rang 0-100, lower is better	Change from baseline (right before treatment start) up to 12 months after treatment
Change in Daily function	World Health Organization Disability Assessment Schedule (self-rated), score rang 0-100, lower is better	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Treatment credibility	Credibility/Expectancy Questionnaire (self-rated), score range 0-50, higher is better	2 weeks after treatment start (mid-treatment)
Intervention/system usability	System Usability Scale (self-rated), score range 0-100, higher is better	2 weeks after treatment start (mid-treatment)
Treatment satisfaction	Client Satisfaction Questionnaire-8 (self-rated), score range 8-32, higher is better	Immediately after treatment (4 weeks after treatment start)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician time	Time in minutes the clinician spends on the participant giving guidance through telephone calls and/or written guidance, in minutes, lower is better	Immediately after treatment (4 weeks after treatment start)

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Insomnia; Optimization; Digital Intervention; ICBT; Factorial Experiment; User Interface; Adaptive Treatment Strategy; Prompts
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2022-07226-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD available anonymized on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No