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

March 10, 2025 updated by: Martin Kraepelien, Karolinska Institutet
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
447

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Centre for Psychiatry Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Up to 12 months after treatment
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
Immediately after treatment (4 weeks after treatment start)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline (right before treatment start) up to 12 months after treatment
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
Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
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
Change from baseline (right before treatment start) up to 12 months after treatment
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
Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
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
Change from baseline (right before treatment start) up to 12 months after treatment
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
Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
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
Change from baseline (right before treatment start) up to 12 months after treatment
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
Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
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
Change from baseline (right before treatment start) up to 12 months after treatment
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
Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Treatment credibility
Time Frame: 2 weeks after treatment start (mid-treatment)
Credibility/Expectancy Questionnaire (self-rated), score range 0-50, higher is better
2 weeks after treatment start (mid-treatment)
Intervention/system usability
Time Frame: 2 weeks after treatment start (mid-treatment)
System Usability Scale (self-rated), score range 0-100, higher is better
2 weeks after treatment start (mid-treatment)
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
Immediately after treatment (4 weeks after treatment start)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Immediately after treatment (4 weeks after treatment start)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Region Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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