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Completed

NCT Number: NCT05826002

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Psychiatry Research

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Sleep diseases, such as narcolepsy or sleep apnea.
  • 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.
  • Alcohol/drug abuse, or medication with side effects on sleep (however, sleep medication is allowed).
  • Working nights or night shifts.

Treatment and study plan

Digital self-guided psychological intervention for insomnia

Behavioral

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.

Primary outcomes

  1. Engagement with intervention method

    Time frame: Up to 12 months after treatment

    Treatment engagement questionnaire (self-rated study-specific questionnaire), score range 0-21 (0-7 per item), higher is better

  2. Engagement with intervention method

    Time frame: 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 outcomes

  1. Change in Insomnia symptoms

    Time frame: Change from baseline (right before treatment start) up to 12 months after treatment

    Insomnia Severity Index (self-rated), score range 0-28, lower is better

  2. Change in Insomnia symptoms

    Time frame: 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

  3. Change in Depression symptoms

    Time frame: Change from baseline (right before treatment start) up to 12 months after treatment

    Patient Health Questionnaire-9 (self-rated), score range 0-27, lower is better

  4. Change in Depression symptoms

    Time frame: 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

  5. Change in Anxiety symptoms

    Time frame: Change from baseline (right before treatment start) up to 12 months after treatment

    Generalized Anxiety Disorder-7 (self-rated), score range 0-21, lower is better

  6. Change in Anxiety symptoms

    Time frame: 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

  7. Change in Life quality

    Time frame: Change from baseline (right before treatment start) up to 12 months after treatment

    Brunnsviken Brief Quality of life scale (self-rated), score range 0-96, higher is better

  8. Change in Life quality

    Time frame: 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

  9. Change in Daily function

    Time frame: Change from baseline (right before treatment start) up to 12 months after treatment

    World Health Organization Disability Assessment Schedule (self-rated), score rang 0-100, lower is better

  10. Change in Daily function

    Time frame: 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

  11. Treatment credibility

    Time frame: 2 weeks after treatment start (mid-treatment)

    Credibility/Expectancy Questionnaire (self-rated), score range 0-50, higher is better

  12. Intervention/system usability

    Time frame: 2 weeks after treatment start (mid-treatment)

    System Usability Scale (self-rated), score range 0-100, higher is better

  13. Treatment satisfaction

    Time frame: Immediately after treatment (4 weeks after treatment start)

    Client Satisfaction Questionnaire-8 (self-rated), score range 8-32, higher is better

Other outcomes

  1. Clinician time

    Time frame: Immediately after treatment (4 weeks after treatment start)

    Time in minutes the clinician spends on the participant giving guidance through telephone calls and/or written guidance, in minutes, lower is better

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2023
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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