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OpenTrials
Completed

NCT Number: NCT03002402

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

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).

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Key information

Conditions

Asthma Bronchial Diseases Dyssomnias Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Insomnia Chronic Lung Diseases Lung Diseases, Obstructive Mental Disorders Nervous System Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based CBT-I

Behavioral

Internet-based cognitive-behavioral treatment for insomnia

Other names: Sleep Healthy Using the Internet (SHUTi)

Primary outcomes

  1. Insomnia severity

    Time frame: baseline and post-intervention (up to 9 weeks)

    Insomnia Severity Index

  2. Asthma control

    Time frame: baseline and post-intervention (up to 9 weeks)

    Asthma Control Test

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 23, 2016
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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