- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03002402
Feasibility and Acceptability of an Internet-based Cognitive-behavioral Treatment for Insomnia in Adults With Asthma
April 3, 2018 updated by: Faith Luyster, University of Pittsburgh
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15261
- University of Pittsburgh
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Internet-based CBT-I
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).
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Internet-based cognitive-behavioral treatment for insomnia
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia severity
Time Frame: baseline and post-intervention (up to 9 weeks)
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Insomnia Severity Index
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baseline and post-intervention (up to 9 weeks)
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Asthma control
Time Frame: baseline and post-intervention (up to 9 weeks)
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Asthma Control Test
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baseline and post-intervention (up to 9 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Faith S Luyster, PhD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
July 17, 2017
Study Completion (Actual)
July 17, 2017
Study Registration Dates
First Submitted
December 19, 2016
First Submitted That Met QC Criteria
December 20, 2016
First Posted (Estimate)
December 23, 2016
Study Record Updates
Last Update Posted (Actual)
April 5, 2018
Last Update Submitted That Met QC Criteria
April 3, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Sleep Initiation and Maintenance Disorders
- Asthma
Other Study ID Numbers
- 1R03HL135213-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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