Digital Psychological Self-care for Sleep Problems

Study Overview
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Brief Summary
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In this non-randomized treatment feasibility pilot we want to explore if a simplified version of CBT-i as a non-therapist-guided digital tool can work; if the digital tool is perceived as user friendly and if participants' insomnia severity is improved following four weeks of treatment.

Official Title
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Self-guided Digital Psychological Self-care for Individuals With Sleep Problems - Feasibility and Preliminary Effects

Conditions
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Chronic Insomnia

Intervention / Treatment
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* Behavioral: Digital self-guided CBT-i


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insomnia complaints of at least medium severity (15 or above on the ISI) Insomnia disorder according to DSM-5 Adequate language skills (Swedish) No foreseeable practical hinders to participate Can wear actigraph 24/7 Daily access to the internet, via computer, smart phone or tablet Exclusion Criteria: Sleep disorders requiring other treatment (e.g. sleep apnea) Somatic or psychiatric disorders that require other treatment (e.g. suicide risk, severe depression) or that decrease level of functioning enough to prevent working independently. Use of alcohol or drugs in a way that will affect sleep negatively, use of medications with a negative impact on sleep. (Stable use of anti depressants and stable use or tapering of hypnotics are allowed) Night work or shift work involving night work Ongoing or previous psychological treatment including sleep restricion and stimulus control

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
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment Pragmatic, within-group pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>The intervention consists of a self-guided digital tool to guide participants with chronic insomnia through sleep restriction and stimulus control procedures. | Behavioral: Digital self-guided CBT-i<br>* A brief version of CBT-i consisting of brief psychoeducation, and the core components sleep restricion and stimulus control, where sleep restriction is based on a simplified sleep diary.<br>* Other names: Self-care digital tool;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | 7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome) | From base-line to 4 weeks | 
| Insomnia Severity Index | 7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represent higher severity (worse outcome) | From base-line to 20 weeks | 
| Treatment acceptability/usefulness | Qualitative quesions regarding participant perception of using the digital tool (ease of use, whether the tool was helpful) | From base-line to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-9) | 9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome) | From base-line to 4 weeks | 
| Patient Health Questionnaire (PHQ-9) | 9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome) | From base-line to 20 weeks | 
| Generalized Anxiety Disorder Scale (GAD7) | 7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome) | From base-line to 4 weeks | 
| Generalized Anxiety Disorder Scale (GAD7) | 7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome) | From base-line to 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital tool, Self-guided