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Mobile Intervention to Improve Functional Health and Community Engagement of Post-9/11 Veterans With Chronic Insomnia

Primary Purpose

Chronic Insomnia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CBTI app intervention

Physical Activity intervention

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring mobile health, physical activity

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Eligible individuals will be US military Veterans
Eligible veterans will have served in the military during the post-9/11 period
Eligible veterans will have chronic, functionally impairing insomnia (i.e., at baseline veterans must have an Insomnia Severity Index score > 10 with insomnia duration of at least 1 month, and impaired daytime functioning.
Eligible individuals must be willing to use devices (e.g., Fitbit, WatchPAT)provided by the study team.
Eligible individuals may have mild or moderate obstructive sleep apnea (as determined by one out of either of two nights with a WatchPAT-based Apnea-Hypopnea Index [AHI] <= 30 events/hour of sleep).

Exclusion Criteria:

Periodic leg movements
Circadian rhythm disorder
Use of medications or health issues (e.g., permanent pacemaker, sustained non-sinus cardiac arrhythmias, finger deformity, etc.) that would interfere with the use of the WatchPAT sleep monitor
Severe obstructive sleep apnea (as determined by one out of either of two nights with a WatchPAT-based Apnea-Hypopnea Index [AHI] > 30 events/hour of sleep)

Sites / Locations

Edith Nourse Rogers Memorial VA Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBTI app intervention

CBTI app+Physical Activity Intervention

Arm Description

Cognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide

Cognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide plus self-management guidance on increased step counts

Outcomes

Primary Outcome Measures

Insomnia Severity Index Total Score

Total score on the Insomnia Severity Index

Pittsburgh Sleep Quality Index Total Score

Total score on the Pittsburgh Sleep Quality Index Total Score

Secondary Outcome Measures

Objective Sleep Efficiency

Time spent in bed divided by time spent asleep as measured by the WatchPAT sleep monitor

Daily step counts

Daily step counts as measured by a Fitbit device

Full Information

NCT ID

NCT03305354

First Posted

October 4, 2017

Last Updated

August 19, 2019

Sponsor

Northeastern University

Collaborators

Edith Nourse Rogers Memorial Veterans Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03305354

Brief Title

Mobile Intervention to Improve Functional Health and Community Engagement of Post-9/11 Veterans With Chronic Insomnia

Official Title

Mobile Intervention to Improve Functional Health and Community Engagement of Post-9/11 Veterans With Chronic Insomnia: Does Enhancing Physical Activity Help?

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

January 31, 2018 (Actual)

Primary Completion Date

June 27, 2019 (Actual)

Study Completion Date

June 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northeastern University

Collaborators

Edith Nourse Rogers Memorial Veterans Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Veterans of the most recent wars in Afghanistan and Iraq (collectively, post 9/11 Veterans) have notable sleep problems including chronic insomnia. Here, the investigators plan to compare two groups of veterans with insomnia: (1) one group that completes a 6 week self-management-guided use of a mobile app based on cognitive behavioral therapy for insomnia (CBTI alone) and (2) one group that completes a 6 week combined self-management-guided use of the mobile CBTI app in addition to a physical activity (PA) intervention (CBTI + PA). The investigators hypothesize that the group receiving the adjunctive 6-week PA intervention will have better subjective and objective sleep, higher step counts, and better functional health and social and community integration than those receiving CBTI alone. This pilot work will provide evidence to guide the design of a future randomized controlled trial.

Detailed Description

To determine if the addition of physical activity (PA) to (CBTI) can further enhance sleep, physical activity, functioning, or social engagement over and above self-management use of a CBTI app alone, the investigators will randomly assign post-9/11 veteran participants with chronic, functionally impairing insomnia to either (1) a self-management-based use of an app based on cognitive behavioral therapy for insomnia (CBTI; CBTI alone arm) or to (2) a self-management-based use of the CBTI app + a physical activity (PA) intervention (CBTI + PA) that includes PA monitoring (via a Fitbit device) with individualized goal-setting to encourage increased daily steps across the 6 weeks. For the PA goal, the investigators will attempt to get all participants to at least the typical 10,000 daily steps goal cited as a strong predictor of positive health outcomes (Choi, Pak, & Choi, 2007). The investigators will tailor the step goals based on the person's initial level of daily steps, and increment step goals weekly to maximize motivation and enhance the likelihood that the participant can meet the goal.

6. Conditions and Keywords

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

Chronic Insomnia

Keywords

mobile health, physical activity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBTI app intervention

Arm Type

Experimental

Arm Description

Cognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide

Arm Title

CBTI app+Physical Activity Intervention

Arm Type

Active Comparator

Arm Description

Cognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide plus self-management guidance on increased step counts

Intervention Type

Behavioral

Intervention Name(s)

CBTI app intervention

Intervention Description

Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep

Intervention Type

Behavioral

Intervention Name(s)

Physical Activity intervention

Intervention Description

Self-management guided motivation to increase physical activity by increasing daily step counts

Primary Outcome Measure Information:

Title

Insomnia Severity Index Total Score

Description

Total score on the Insomnia Severity Index

Time Frame

6 weeks (Immediate post-intervention)

Title

Pittsburgh Sleep Quality Index Total Score

Description

Total score on the Pittsburgh Sleep Quality Index Total Score

Time Frame

6 weeks (Immediate post-intervention)

Secondary Outcome Measure Information:

Title

Objective Sleep Efficiency

Description

Time spent in bed divided by time spent asleep as measured by the WatchPAT sleep monitor

Time Frame

6 weeks (Immediate post-intervention)

Title

Daily step counts

Description

Daily step counts as measured by a Fitbit device

Time Frame

6 weeks (Immediate post-intervention)

Other Pre-specified Outcome Measures:

Title

Functional Outcomes of Sleep

Description

Functional Outcomes of Sleep Questionnaire total score (10 item version)

Time Frame

6 weeks (Immediate post-intervention)

Title

Social Engagement

Description

Total score on the Lubben Social Network Scale

Time Frame

6 weeks (Immediate post-intervention)

Title

Community Engagement

Description

Total score on the Community Integration Questionnaire

Time Frame

6 weeks (Immediate post-intervention)

Title

Physical Functional Health

Description

Physical Function score from the Veteran's RAND-12 scale

Time Frame

6 weeks (Immediate post-intervention)

Title

Mental Functional Health

Description

Mental Function score from the Veteran's RAND-12 scale

Time Frame

6 weeks (Immediate post-intervention)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eligible individuals will be US military Veterans Eligible veterans will have served in the military during the post-9/11 period Eligible veterans will have chronic, functionally impairing insomnia (i.e., at baseline veterans must have an Insomnia Severity Index score > 10 with insomnia duration of at least 1 month, and impaired daytime functioning. Eligible individuals must be willing to use devices (e.g., Fitbit, WatchPAT)provided by the study team. Eligible individuals may have mild or moderate obstructive sleep apnea (as determined by one out of either of two nights with a WatchPAT-based Apnea-Hypopnea Index [AHI] <= 30 events/hour of sleep). Exclusion Criteria: Periodic leg movements Circadian rhythm disorder Use of medications or health issues (e.g., permanent pacemaker, sustained non-sinus cardiac arrhythmias, finger deformity, etc.) that would interfere with the use of the WatchPAT sleep monitor Severe obstructive sleep apnea (as determined by one out of either of two nights with a WatchPAT-based Apnea-Hypopnea Index [AHI] > 30 events/hour of sleep)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen S Quigley, PhD

Organizational Affiliation

Northeastern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Edith Nourse Rogers Memorial VA Hospital

City

Bedford

State/Province

Massachusetts

ZIP/Postal Code

01730

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34889746

Citation

Reilly ED, Robinson SA, Petrakis BA, Gardner MM, Wiener RS, Castaneda-Sceppa C, Quigley KS. Mobile Intervention to Improve Sleep and Functional Health of Veterans With Insomnia: Randomized Controlled Trial. JMIR Form Res. 2021 Dec 9;5(12):e29573. doi: 10.2196/29573.

Results Reference

derived

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Mobile Intervention to Improve Functional Health and Community Engagement of Post-9/11 Veterans With Chronic Insomnia

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