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

Not Applicable

Completed

• Conditions: Asthma; Insomnia Chronic
• Interventions: Behavioral: Internet-based CBT-I

• Registration Number: NCT03002402
• Lead Sponsor: University of Pittsburgh

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-23
• Study Start: 2017-02-01
• Primary Completion: 2017-07-17
• Study Completion: 2017-07-17
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet-based CBT-I	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).

Primary Outcome Measures

Name	Time	Method
Insomnia severity	baseline and post-intervention (up to 9 weeks)	Insomnia Severity Index
Asthma control	baseline and post-intervention (up to 9 weeks)	Asthma Control Test

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States