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

NCT03002402 | Completed

• 1 other identifier: 1R03HL135213-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Asthma; Insomnia Chronic

Keywords

asthma; insomnia; cognitive-behavioral treatment

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Internet-based CBT-I

EXPERIMENTAL

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

Interventions

Internet-based CBT-I BEHAVIORAL

Internet-based cognitive-behavioral treatment for insomnia

Also known as: Sleep Healthy Using the Internet (SHUTi)

Internet-based CBT-I

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Asthma; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Faith S Luyster, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 23, 2016
• Study Start: February 1, 2017
• Primary Completion: July 17, 2017
• Study Completion: July 17, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)