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

NCT03305354 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-08-20

No results posted yet for this study

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.

Conditions

  • Chronic Insomnia

Interventions

BEHAVIORAL

CBTI app intervention

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

BEHAVIORAL

Physical Activity intervention

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

Sponsors & Collaborators

  • Edith Nourse Rogers Memorial Veterans Hospital

    collaborator FED

  • Northeastern University

    lead OTHER

Principal Investigators

  • Karen S Quigley, PhD · Northeastern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2019-06-27
Completion
2019-06-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03305354 on ClinicalTrials.gov