Clinical trial NCT03963908: Evidence-based Pain Intervention for Veterans: AtEase for Chronic Pain
Official title: Evidence-based Pain Intervention for Veterans: Leveraging Mobile & Social Media: A Randomized 262-subject Controlled Trial of AtEase, a Pain Self-management App in the Treatment of Chronic Pain in Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
stage of change
pain self management
mobile applications
Transtheoretical Model
Lead sponsor: Pro-Change Behavior Systems
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study involves a 2-group X 3 occasion randomized trial that will examine whether AtEase produces more significant improvements in PEG scores (which reflect total pain intensity and pain interference) than a comparison intervention (i.e., an existing online pain self-management intervention entitled Chronic Pain Education for Veterans).
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a randomized controlled trial to test the efficacy AtEase, a pain self-management app in a sample of Veterans with chronic musculoskeletal pain. The primary outcome is changes in PEG scores from baseline to final follow-up (12 months).

Detailed description: The primary objectives of this project are to develop and examine the effectiveness of a mobile app (AtEase) that is designed to provide tailored behavior change guidance to promote pain self-management, healthy sleep habits, and effective stress management in a randomized clinical trial including 262 Veterans with chronic pain.

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.

Eligibility criteria: Inclusion Criteria:

* Male or female Veteran
* 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:

* Life-threatening condition or acute medical conditions that precludes participation
* Psychiatric conditions that could impair participation
* Suicidal ideation or intent
* Inability to read or speak English
* Unwilling or unable to provide informed consent

Primary outcomes:
measure: PEG
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Global Impression of Change
timeFrame: 12 months
measure: Pain Level
timeFrame: Baseline to 12 months
measure: Readiness to self-manage pain
timeFrame: Baseline to 12 months
measure: Stage of change for healthy sleep habits
timeFrame: Baseline to 12 months
measure: Stage of change for stress management
timeFrame: Baseline to 12 months
measure: Post-Traumatic Stress Disorder (PTSD) Checklist (PCL-5)
timeFrame: Baseline to 12 months
measure: Well-Being
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
city: South Kingstown
country: United States
facility: Pro-Change Behavior Systems, Inc
state: Rhode Island
Study officials:
affiliation: Pro-Change Behavior Systems, Inc.
name: Sara Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: