Evidence-based Pain Intervention for Veterans: AtEase for Chronic Pain
NCT ID: NCT03963908
Last Updated: 2022-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
268 participants
INTERVENTIONAL
2019-09-15
2021-04-12
Brief Summary
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Detailed Description
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Veterans will be recruited from VA Connecticut Healthcare, as well as from numerous diverse community recruitment channels (including employers, community groups that provide services for Veterans, Student Veterans of America, and social media).
Eligible Veterans will be randomized to receive access to AtEase or the comparison intervention (a mobile-optimized adaptation of Chronic Pain Education for Veterans) for a total of 6 months. AtEase is a tailored pain self-management mobile app that tailors participant's feedback based on readiness to engage in pain self-management and preference for self-management strategies. Chronic Pain Education for Veterans is a free VA-endorsed publicly available pain management online educational curriculum that provides cognitive-behavioral therapy-based pain self-management materials.
Between the baseline assessment and the 6-month follow up assessment, participants will have unlimited access AtEase or the Chronic Pain Education for Veterans program. All participants will complete follow-up assessments at 6 months and 12-months post-baseline.
The primary outcome will be a comparison of PEG scores at 12 months follow-up. Secondary outcomes will include pain,Global Impression of Change; readiness to self-manage pain, manage stress, and engage in healthy sleep habits; well-being; and Post Traumatic Stress Disorder Checklist scores.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention
AtEase is a mobile app designed to promote pain self-management, healthy sleep habits, and effective stress management. It includes a tailored Newsfeed that updates regularly with articles, activities, videos, and quizzes chosen for the user; a chat feature that asks questions and provide tailored feedback; a Message Center; and a Pain Tracker. Users can interact with AtEase as often as they like for six months.
AtEase
AtEase is a tailored pain self-management mobile app that tailors participant's feedback based on readiness to engage in pain self-management and preference for self-management strategies.
Comparison
Chronic Pain Education for Veterans is a VA-endorsed pain management online educational curriculum that provides CBT pain self-management materials. Users randomized to the comparison condition will have unlimited access for 6 months.
Chronic Pain Education
CBT-based Education on Pain Self-Management for Veterans
Interventions
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AtEase
AtEase is a tailored pain self-management mobile app that tailors participant's feedback based on readiness to engage in pain self-management and preference for self-management strategies.
Chronic Pain Education
CBT-based Education on Pain Self-Management for Veterans
Eligibility Criteria
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Inclusion Criteria
* Chronic musculoskeletal pain defined as (numeric rating scale of \>4) (10 point scale) for \> 3 months.43
* Internet connectivity via tablet or mobile phone.
Exclusion Criteria
* Psychiatric conditions that could impair participation
* Suicidal ideation or intent
* Inability to read or speak English
* Unwilling or unable to provide informed consent
18 Years
ALL
Yes
Sponsors
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Pro-Change Behavior Systems
OTHER
Responsible Party
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Sara Johnson
Co-President & CEO
Principal Investigators
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Sara Johnson, PhD
Role: PRINCIPAL_INVESTIGATOR
Pro-Change Behavior Systems, Inc.
Locations
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VA Connecticut Healthcare System
West Haven, Connecticut, United States
Pro-Change Behavior Systems, Inc
South Kingstown, Rhode Island, United States
Countries
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Other Identifiers
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