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

Study Overview
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Brief Summary
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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.

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

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Digital self-guided psychological intervention for insomnia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Digital insomnia intervention<br>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<br>* 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.<br>|
| Active Comparator: Digital insomnia intervention + optimized user interface<br>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<br>* 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.<br>|
| Active Comparator: Digital insomnia intervention + adaptive treatment strategy<br>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<br>* 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.<br>|
| Active Comparator: Digital insomnia intervention + optimized user interface, adaptive treatment strategy<br>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<br>* 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.<br>|
| Active Comparator: Digital insomnia intervention + daily prompts<br>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<br>* 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.<br>|
| Active Comparator: Digital insomnia intervention + optimized user interface, daily prompts<br>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<br>* 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.<br>|
| Active Comparator: Digital insomnia intervention + adaptive treatment strategy, daily prompts<br>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<br>* 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.<br>|
| Active Comparator: Digital insomnia intervention + optimized user interface, adaptive treatment strategy, daily prompts<br>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<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, ICBT, Factorial Experiment, Optimization, User Interface, Adaptive Treatment Strategy, Prompts, Digital Intervention