Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools (REACT (AI CBT))
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
West Haven, Connecticut, United States, 06516-2770
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
-
-
Michigan
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Ann Arbor, Michigan, United States, 48105-2303
- VA Ann Arbor Healthcare System, Ann Arbor, MI
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Back pain-related dx including back and spine conditions and nerve compression and a score of >=4 (indicating moderate pain) on the 0-10 Numerical Rating Scale on at least two separate outpatient encounters in the past year
- At least 1 outpatient visit in last 12 months
- At least moderate pain-related disability as determined by a score of 5+on the Roland Morris Disability Questionnaire
- At least moderate musculoskeletal pain as indicated by a pain score of >=4 on the Numeric Rating Scale
- Pain on at least half the days of the prior 6 months as reported on the Chronic Pain item
- Touch-tone cell or land line phone.
Exclusion Criteria:
- COPD requiring oxygen
- Cancer requiring chemotherapy
- Currently receiving CBT
- Suicidality
- Receiving surgical tx related to back pain
- Active psychotic symptoms
- Severe depressive symptoms
- Can't speak English
- Sensory deficits that would impair participation in telephone calls
- Patient not planning to get care at study site
- PCP not affiliated with study site
- Limited life expectancy (COPD requiring oxygen or Cancer requiring chemotherapy
- Active psychotic symptoms, suicidality, severe depressive symptoms (Beck Depression Inventory (BDI) score or 30+)
- Substance use disorder or dependence, active manic episode, or poorly controlled bipolar disorder as identified by MMini International Neuropsychiatric Interview
- Severe depression identified by chart review of diagnoses and mental health treatment notes
- Cognitive impairment defined by a score of <=5 on the Six-Item screener
- Current CBT or surgical treatment related to back pain.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: AI CBT
AI CBT engine will make recommendations to step-down or step-up intensity of CBT FU based on what patient reports and what other similar patients report.
Stepped care model.
|
AI CBT engine will make recommendations to step-down or step-up intensity of CBT follow-up based on what patient reports and what other similar patients report.
Stepped care model.
|
|
Active Comparator: Standard telephone CBT
Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
|
Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain-related Disability
Time Frame: 3 and 6 months post enrollment
|
The Roland Morris Disability Questionnaire (RMDQ) is a 24-item checklist designed for patients to identify the level of disability and functional status associated with chronic low back pain.
Patients are instructed to endorse items that describe their functional status that day.
Scores range from 0-24, with higher scores indicating more disability.
|
3 and 6 months post enrollment
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global Pain Intensity
Time Frame: 3 and 6 months post enrollment
|
An 11-point Numeric Rating Scale (NRS) for pain severity, with 0 representing "No pain" and 10 representing the "Worst pain imaginable."
Patients were asked to rate their level of pain on average in the last week.
|
3 and 6 months post enrollment
|
|
Pain-Related Interference
Time Frame: 3 and 6 months post enrollment
|
Pain-related interference was measured using the Brief Pain Inventory - Short Form (BPI).
Scores range from 0-10, with higher scores indicating more interference.
|
3 and 6 months post enrollment
|
|
Depression Symptom Severity
Time Frame: 3 and 6 months post enrollment
|
Depression symptom severity was assessed using the 9-item Patient Health Questionnaire (PHQ-9).
Scores range from 0-27, with higher scores indicating more depression symptom severity.
|
3 and 6 months post enrollment
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Alicia A. Heapy, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
- Principal Investigator: John D. Piette, PhD, VA Ann Arbor Healthcare System, Ann Arbor, MI
Publications and helpful links
General Publications
- Piette JD, Krein SL, Striplin D, Marinec N, Kerns RD, Farris KB, Singh S, An L, Heapy AA. Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: Protocol for a Randomized Study Funded by the US Department of Veterans Affairs Health Services Research and Development Program. JMIR Res Protoc. 2016 Apr 7;5(2):e53. doi: 10.2196/resprot.4995.
- Piette JD, Newman S, Krein SL, Marinec N, Chen J, Williams DA, Edmond SN, Driscoll M, LaChappelle KM, Kerns RD, Maly M, Kim HM, Farris KB, Higgins DM, Buta E, Heapy AA. Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. JAMA Intern Med. 2022 Sep 1;182(9):975-983. doi: 10.1001/jamainternmed.2022.3178.
- MacLean RR, Buta E, Higgins DM, Driscoll MA, Edmond SN, LaChappelle KM, Ankawi B, Krein SL, Piette JD, Heapy AA. Using Daily Ratings to Examine Treatment Dose and Response in Cognitive Behavioral Therapy for Chronic Pain: A Secondary Analysis of the Co-Operative Pain Education and Self-Management Clinical Trial. Pain Med. 2023 Jul 5;24(7):846-854. doi: 10.1093/pm/pnac192.
- Mattocks KM, LaChappelle KM, Krein SL, DeBar LL, Martino S, Edmond S, Ankawi B, MacLean RR, Higgins DM, Murphy JL, Cooper E, Heapy AA. Pre-implementation formative evaluation of cooperative pain education and self-management expanding treatment for real-world access: A pragmatic pain trial. Pain Pract. 2023 Apr;23(4):338-348. doi: 10.1111/papr.13195. Epub 2022 Dec 29.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IIR 13-350
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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