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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03963908
• Other study ID #: 9R44AT009675-02
• Status: Completed
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: April 12, 2021

Study information

• Verified date: February 2022
• Source: Pro-Change Behavior Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: April 12, 2021
• Est. primary completion date: April 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Pro-Change Behavior Systems, Inc	South Kingstown	Rhode Island
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pro-Change Behavior Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PEG	The PEG is a multi-dimensional three-item assessment that measures average pain rating, as well as both emotional and physical functioning.	Baseline to 12 months
Secondary	Global Impression of Change	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.	12 months
Secondary	Pain Level	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.	Baseline to 12 months
Secondary	Readiness to self-manage pain	Changes in participant's stage of change for using self-management strategies using a stage of change algorithm	Baseline to 12 months
Secondary	Stage of change for healthy sleep habits	Readiness to get at least 7 hours of sleep a night	Baseline to 12 months
Secondary	Stage of change for stress management	Readiness to effectively manage stress	Baseline to 12 months
Secondary	Post-Traumatic Stress Disorder (PTSD) Checklist (PCL-5)	PTSD symptoms will be measured using the 20-item PCL-5, which assesses the 20 symptoms of PTSD.	Baseline to 12 months
Secondary	Well-Being	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.	Baseline to 12 months