NCT03963908

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2021

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1.6 years

First QC Date

May 23, 2019

Last Update Submit

February 28, 2022

Conditions

Chronic Pain

Keywords

chronic painstage of changepain self managementmobile applicationsTranstheoretical Model

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Global Impression of Change

    12 months

  • Pain Level

    Baseline to 12 months

  • Readiness to self-manage pain

    Baseline to 12 months

  • Stage of change for healthy sleep habits

    Baseline to 12 months

  • Stage of change for stress management

    Baseline to 12 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: AtEase

Comparison

ACTIVE COMPARATOR

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.

Behavioral: Chronic Pain Education

Interventions

AtEaseBEHAVIORAL

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.

Intervention
Chronic Pain EducationBEHAVIORAL

CBT-based Education on Pain Self-Management for Veterans

Comparison

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Pro-Change Behavior Systems, Inc

South Kingstown, Rhode Island, 02879, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sara Johnson, PhD

    Pro-Change Behavior Systems, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to group assignment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-President & CEO

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 28, 2019

Study Start

September 15, 2019

Primary Completion

April 12, 2021

Study Completion

April 12, 2021

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)