Feasibility and Acceptability of an Internet-based Cognitive-behavioral Treatment for Insomnia in Adults With Asthma

Study Overview
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Brief Summary
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The purpose of the proposed study are to explore changes in sleep and asthma outcomes from baseline to post-treatment in adults with asthma and comorbid insomnia who underwent Internet-based cognitive-behavioral treatment for insomnia (CBT-I).

Official Title
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Feasibility and Acceptability of an Internet-based Cognitive-behavioral Treatment for Insomnia in Adults With Asthma

Conditions
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Asthma, Insomnia Chronic

Intervention / Treatment
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* Behavioral: Internet-based CBT-I


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of moderate-severe persistent asthma Not well controlled asthma (score ≤ 19 on the Asthma Control Test) Age 18-75 years Meets criteria for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Insomnia Disorder At least moderate insomnia severity (score ≥ 10 on Insomnia Severity Index) Telephone number, email address, and reliable Internet access Exclusion Criteria: History of bipolar or psychosis Substance abuse disorder within past 3 months Dementia or probable dementia diagnosis Plans to move or leave present source of care during the following 6 months. Non-English speaking, illiterate, or possesses sensory deficits

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based CBT-I<br>Sleep Healthy Using the Internet (SHUTi) is a self-guided, automated, interactive, and tailored web-based program modeled on the primary tenets of cognitive-behavioral treatment for insomnia (CBT-I): sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. Intervention content is allocated out over time through 6 Cores. Users obtain access to a new Core based on a time and event-based schedule (e.g., 7 days after completion of previous Core). SHUTi uses online sleep diaries to track progress and to tailor treatment (e.g., assign a sleep restriction window). | Behavioral: Internet-based CBT-I<br>* Internet-based cognitive-behavioral treatment for insomnia<br>* Other names: Sleep Healthy Using the Internet (SHUTi);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia severity | Insomnia Severity Index | baseline and post-intervention (up to 9 weeks) | 
| Asthma control | Asthma Control Test | baseline and post-intervention (up to 9 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, insomnia, cognitive-behavioral treatment