Chronic PainNCT03963908
Evidence-based Pain Intervention for Veterans: AtEase for Chronic Pain
A study testing AtEase and Chronic Pain Education in people with Chronic Pain, run by Pro-Change Behavior Systems at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- AtEase and Chronic Pain Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2019to 12 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Pro-Change Behavior Systems, Inc
South Kingstown, Rhode Island, 02879
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
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
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).
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- AtEase, Chronic Pain Education
- Keywords
- chronic pain, stage of change, pain self management, mobile applications, Transtheoretical Model
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtEaseBehavioural
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 EducationBehavioural
CBT-based Education on Pain Self-Management for Veterans
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Chronic Pain Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEG
The PEG is a multi-dimensional three-item assessment that measures average pain rating, as well as both emotional and physical functioning.
Measured: Baseline to 12 months
Secondary outcomes (7)
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.
Measured: 12 months
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.
Measured: Baseline to 12 months
Readiness to self-manage pain
Changes in participant's stage of change for using self-management strategies using a stage of change algorithm
Measured: Baseline to 12 months
Stage of change for healthy sleep habits
Readiness to get at least 7 hours of sleep a night
Measured: Baseline to 12 months
Stage of change for stress management
Readiness to effectively manage stress
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start15 Sep 2019
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pro-Change Behavior Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Johnson, Pro-Change Behavior Systems
- Investigators
- Sara Johnson, PhD, Principal investigator, Pro-Change Behavior Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963908
- Sponsor's protocol ID
- 9R44AT009675-02
- Status last verified
- Feb 2022
- First submitted
- 23 May 2019
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03963908
- Acronym / sponsor ID
- 9R44AT009675-02
- Conditions
- Chronic Pain
- Keywords
- chronic pain, stage of change, pain self management, mobile applications, Transtheoretical Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Pro-Change Behavior SystemsUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: AtEaseAtEase 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. |
| Comparison | Active comparator | Behavioral: Chronic Pain EducationChronic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtEaseAtEase 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. | Behavioural | Intervention |
| Chronic Pain EducationCBT-based Education on Pain Self-Management for Veterans | Behavioural | Comparison |
Primary outcome
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.
7 secondary outcomes
Global Impression of Change
Time frame: 12 months
Pain Level
Time frame: Baseline to 12 months
Readiness to self-manage pain
Time frame: Baseline to 12 months
Stage of change for healthy sleep habits
Time frame: Baseline to 12 months
Stage of change for stress management
Time frame: Baseline to 12 months
Post-Traumatic Stress Disorder (PTSD) Checklist (PCL-5)
Time frame: Baseline to 12 months
Well-Being
Time frame: Baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Johnson, PhD principal investigator
Pro-Change Behavior Systems, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AtEase and Chronic Pain Education in people with Chronic Pain, run by Pro-Change Behavior Systems at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PEG (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.