Chronic Pain
Conditions
Keywords
chronic pain, stage of change, pain self management, mobile applications, Transtheoretical Model
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.
Interventions
BEHAVIORALAtEase
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.
BEHAVIORALChronic Pain Education
CBT-based Education on Pain Self-Management for Veterans
Sponsors
Pro-Change Behavior Systems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to group assignment.
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PEG | Baseline to 12 months | The PEG is a multi-dimensional three-item assessment that measures average pain rating, as well as both emotional and physical functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level | Baseline to 12 months | Level of pain will also be assessed by asking participants to rate their pain 1) right now, 2) usual level of pain in the last week, 3) best level of pain in the last week, and 4) worst level of pain in the last week. All ratings are on a scale of 0-10, with zero equal to no pain, and 10 equal to worst pain. |
| Readiness to self-manage pain | Baseline to 12 months | Changes in participant's stage of change for using self-management strategies using a stage of change algorithm |
| Stage of change for healthy sleep habits | Baseline to 12 months | Readiness to get at least 7 hours of sleep a night |
| Global Impression of Change | 12 months | The Global Impression of Change scale is recommended43 as a core outcome measure in pain studies. It is a single item that asks participants to describe any change in their condition as a result of using the program. Response options range from 1 = No change (or condition has gotten worse) to 7 = A great deal better, and a considerable improvement that has made all the difference. |
| Post-Traumatic Stress Disorder (PTSD) Checklist (PCL-5) | Baseline to 12 months | PTSD symptoms will be measured using the 20-item PCL-5, which assesses the 20 symptoms of PTSD. |
| Well-Being | Baseline to 12 months | Well-being will be assessed using the Cantril Self-Anchoring Scale, which asks participants to imagine a ladder with steps numbered from 0 to 10, with the top representing the best possible life and the bottom representing the worst possible life. Participants indicate where they feel their life falls currently and where it will fall in five years. |
| Stage of change for stress management | Baseline to 12 months | Readiness to effectively manage stress |
Countries
United States
Outcome results
None listed