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

Sponsor

Karolinska Institutet (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05826002

Collaborator

Region Stockholm (Other)

385

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Behavioral: Digital self-guided psychological intervention for insomnia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

385 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention 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.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:

Single (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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Engagement with intervention method [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
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

Change in Insomnia symptoms [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 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) up to 12 months after treatment]
Patient Health Questionnaire-9 (self-rated), score range 0-27, 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) up to 12 months after treatment]
Generalized Anxiety Disorder-7 (self-rated), score range 0-21, 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) up to 12 months after treatment]
Brunnsviken Brief Quality of life scale (self-rated), score range 0-96, higher 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
Change in Daily function [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 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 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
Treatment satisfaction [Immediately after treatment (4 weeks after treatment start)]
Client Satisfaction Questionnaire-8 (self-rated), score range 8-32, higher is better

Other Outcome Measures

Clinician time [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.