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

Pro-Change Behavior Systems

Status: Completed

Conditions: Chronic Pain

Treatments: Behavioral: Chronic Pain Education; Behavioral: AtEase

Study type: Interventional

Funder types: Other

Identifiers

NCT03963908

9R44AT009675-02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 268 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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268 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: AtEase

Comparison

Active Comparator group

Description:

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.

Treatment:

Behavioral: Chronic Pain Education