Back to results

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

Primary Purpose

Asthma, Insomnia Chronic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Internet-based CBT-I

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, insomnia, cognitive-behavioral treatment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Internet-based CBT-I

Arm Description

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).

Outcomes

Primary Outcome Measures

Insomnia severity

Insomnia Severity Index

Asthma control

Asthma Control Test

Secondary Outcome Measures

Full Information

NCT ID

NCT03002402

First Posted

December 19, 2016

Last Updated

April 3, 2018

Sponsor

University of Pittsburgh

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT03002402

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

February 1, 2017 (Actual)

Primary Completion Date

July 17, 2017 (Actual)

Study Completion Date

July 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Insomnia Chronic

Keywords

asthma, insomnia, cognitive-behavioral treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Internet-based CBT-I

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Internet-based CBT-I

Other Intervention Name(s)

Sleep Healthy Using the Internet (SHUTi)

Intervention Description

Internet-based cognitive-behavioral treatment for insomnia

Primary Outcome Measure Information:

Title

Insomnia severity

Description

Insomnia Severity Index

Time Frame

baseline and post-intervention (up to 9 weeks)

Title

Asthma control

Description

Asthma Control Test

Time Frame

baseline and post-intervention (up to 9 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Faith S Luyster, PhD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15261

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs