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NCT Number: NCT03963908

Evidence-based Pain Intervention for Veterans: AtEase for Chronic Pain

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).

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Connecticut Healthcare System, West Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AtEase

Behavioral

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

Behavioral

CBT-based Education on Pain Self-Management for Veterans

Primary outcomes

  1. PEG

    Time frame: 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 outcomes

  1. Global Impression of Change

    Time frame: 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.

  2. Pain Level

    Time frame: 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.

  3. Readiness to self-manage pain

    Time frame: Baseline to 12 months

    Changes in participant's stage of change for using self-management strategies using a stage of change algorithm

  4. Stage of change for healthy sleep habits

    Time frame: Baseline to 12 months

    Readiness to get at least 7 hours of sleep a night

  5. Stage of change for stress management

    Time frame: Baseline to 12 months

    Readiness to effectively manage stress

  6. Post-Traumatic Stress Disorder (PTSD) Checklist (PCL-5)

    Time frame: Baseline to 12 months

    PTSD symptoms will be measured using the 20-item PCL-5, which assesses the 20 symptoms of PTSD.

  7. Well-Being

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pro-Change Behavior Systems

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 28, 2019
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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