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

Primary Purpose

Insomnia

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Digital self-guided psychological intervention for insomnia

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, ICBT, Factorial Experiment, Optimization, User Interface, Adaptive Treatment Strategy, Prompts, Digital Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Centre for Psychiatry ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Arm Label

Digital insomnia intervention

Digital insomnia intervention + optimized user interface

Digital insomnia intervention + adaptive treatment strategy

Digital insomnia intervention + optimized user interface, adaptive treatment strategy

Digital insomnia intervention + daily prompts

Digital insomnia intervention + optimized user interface, daily prompts

Digital insomnia intervention + adaptive treatment strategy, daily prompts

Digital insomnia intervention + optimized user interface, adaptive treatment strategy, daily prompts

Arm Description

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

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

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

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

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

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

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

This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (yes), daily prompts (yes).

Outcomes

Primary Outcome Measures

Engagement with intervention method

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

Engagement with intervention method

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

Secondary Outcome Measures

Change in Insomnia symptoms

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

Change in Insomnia symptoms

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

Change in Depression symptoms

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

Change in Depression symptoms

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

Change in Anxiety symptoms

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

Change in Anxiety symptoms

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

Change in Life quality

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

Change in Life quality

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

Change in Daily function

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

Change in Daily function

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

Treatment credibility

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

Intervention/system usability

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

Treatment satisfaction

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

Full Information

NCT ID

NCT05826002

First Posted

March 27, 2023

Last Updated

May 23, 2023

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

1. Study Identification

Unique Protocol Identification Number

NCT05826002

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2023 (Actual)

Primary Completion Date

April 2025 (Anticipated)

Study Completion Date

April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia

Keywords

Insomnia, ICBT, Factorial Experiment, Optimization, User Interface, Adaptive Treatment Strategy, Prompts, Digital Intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

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.

Masking

Participant

Masking Description

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.

Allocation

Randomized

Enrollment

385 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Digital insomnia intervention

Arm Type

Active Comparator

Arm Description

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

Arm Title

Digital insomnia intervention + optimized user interface

Arm Type

Active Comparator

Arm Description

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

Arm Title

Digital insomnia intervention + adaptive treatment strategy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Digital insomnia intervention + optimized user interface, adaptive treatment strategy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Digital insomnia intervention + daily prompts

Arm Type

Active Comparator

Arm Description

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

Arm Title

Digital insomnia intervention + optimized user interface, daily prompts

Arm Type

Active Comparator

Arm Description

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

Arm Title

Digital insomnia intervention + adaptive treatment strategy, daily prompts

Arm Type

Active Comparator

Arm Description

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

Arm Title

Digital insomnia intervention + optimized user interface, adaptive treatment strategy, daily prompts

Arm Type

Active Comparator

Arm Description

This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (yes), daily prompts (yes).

Intervention Type

Behavioral

Intervention Name(s)

Digital self-guided psychological intervention for insomnia

Intervention Description

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 Outcome Measure Information:

Title

Engagement with intervention method

Description

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

Time Frame

Up to 12 months after treatment

Title

Engagement with intervention method

Description

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

Time Frame

Immediately after treatment (4 weeks after treatment start)

Secondary Outcome Measure Information:

Title

Change in Insomnia symptoms

Description

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

Time Frame

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

Title

Change in Insomnia symptoms

Description

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

Time Frame

Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)

Title

Change in Depression symptoms

Description

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

Time Frame

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

Title

Change in Depression symptoms

Description

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

Time Frame

Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)

Title

Change in Anxiety symptoms

Description

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

Time Frame

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

Title

Change in Anxiety symptoms

Description

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

Time Frame

Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)

Title

Change in Life quality

Description

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

Time Frame

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

Title

Change in Life quality

Description

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

Time Frame

Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)

Title

Change in Daily function

Description

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

Time Frame

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

Title

Change in Daily function

Description

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

Time Frame

Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)

Title

Treatment credibility

Description

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

Time Frame

2 weeks after treatment start (mid-treatment)

Title

Intervention/system usability

Description

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

Time Frame

2 weeks after treatment start (mid-treatment)

Title

Treatment satisfaction

Description

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

Time Frame

Immediately after treatment (4 weeks after treatment start)

Other Pre-specified Outcome Measures:

Title

Clinician time

Description

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

Time Frame

Immediately after treatment (4 weeks after treatment start)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Martin Kraepelien, PhD

Phone

070-301 75 00

martin.kraepelien@ki.se

Facility Information:

Facility Name

Centre for Psychiatry Research

City

Stockholm

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nitya Jayaram-Lindström

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

IPD available anonymized on reasonable request.

Learn more about this trial

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

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