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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002402
• Other study ID #: 1R03HL135213-01
• Secondary ID: 1R03HL135213-01
• Status: Completed
• Phase: N/A
• First received: December 19, 2016
• Last updated: April 3, 2018
• Start date: February 1, 2017
• Est. completion date: July 17, 2017

Study information

• Verified date: April 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 17, 2017
• Est. primary completion date: July 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Insomnia Chronic
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Internet-based CBT-I
Internet-based cognitive-behavioral treatment for insomnia

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia severity	Insomnia Severity Index	baseline and post-intervention (up to 9 weeks)
Primary	Asthma control	Asthma Control Test	baseline and post-intervention (up to 9 weeks)