Back PainREACT (AI CBT)NCT02464449
Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools
A study testing Behavioral: AI-CBT and Behavioral: Standard Telephone CBT in people with Back Pain, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
This study will evaluate a new approach for back pain care management using artificial intelligence and evidence-based cognitive behavioral therapy (AI-CBT) so that services automatically adapt to each Veteran's unique needs, achieving outcomes as good as standard care but with less clinician time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- Behavioral: AI-CBT and Behavioral: Standard Telephone CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jul 2017to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- COPD requiring oxygen
- Cancer requiring chemotherapy
- Currently receiving CBT
- Suicidality
- Receiving surgical tx related to back pain
- Active psychotic symptoms
Show all 17Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
About this study
This study will evaluate a new approach for back pain care management using artificial intelligence and evidence-based cognitive behavioral therapy (AI-CBT) so that services automatically adapt to each Veteran's unique needs, achieving outcomes as good as standard care but with less clinician time.
Read the detailed description
Cognitive behavioral therapy (CBT) is one of the most effective treatments for chronic back pain. However, only half of Veterans have access to trained CBT therapists, and program expansion is costly. Moreover, VA CBT programs consist of 10 weekly hour-long sessions delivered using an approach that is out-of-sync with stepped-care models designed to ensure that scarce resources are used as effectively and efficiently as possible. Data from prior CBT trials have documented substantial variation in patients' needs for extended treatment, and the characteristics of effective programs vary significantly. Some patients improve after the first few sessions while others need more extensive contact. After initially establishing a behavioral plan, still other Veterans may be able to reach behavioral and symptom goals using a personalized combination of manuals, shorter follow-up contacts with a therapist, and automated telephone monitoring and self-care support calls. In partnership with the National Pain Management Program, the investigators propose to apply state-of-the-art principles from "reinforcement learning" (a field of artificial intelligence or AI used successfully in robotics and on-line consumer targeting) to develop an evidence-based, personalized CBT pain management service that automatically adapts to each Veteran's unique and changing needs (AI-CBT). AI-CBT will use feedback from patients about their progress in pain-related functioning measured daily via pedometer step-counts to automatically personalize the intensity and type of patient support; thereby ensuring that scarce therapist resources are used as efficiently as possible and potentially allowing programs with fixed budgets to serve many more Veterans. The specific aims of the study are to: (1) demonstrate that AI-CBT has non-inferior pain-related outcomes compared to standard telephone CBT; (2) document that AI-CBT achieves these outcomes with more efficient use of scarce clinician resources as evidenced by less overall therapist time and no increase in the use of other VA health services; and (3) demonstrate the intervention's impact on proximal outcomes associated with treatment response, including program engagement, pain management skill acquisition, satisfaction with care, and patients' likelihood of dropout. The investigators will use qualitative interviews with patients, clinicians, and VA operational partners to ensure that the service has features that maximize scalability, broad scale adoption, and impact. 278 patients with chronic back pain will be recruited from the VA Connecticut Healthcare System and the VA Ann Arbor Healthcare System, and randomized to standard 10-sessions of telephone CBT versus AI-CBT. All patients will begin with weekly hour-long telephone counseling, but for patients in the AI-CBT group, those who demonstrate a significant treatment response will be stepped down through less resource-intensive alternatives to hour-long contacts, including: (a) 15 minute contacts with a therapist, and (b) CBT clinician feedback provided via interactive voice response calls (IVR). The AI engine will learn what works best in terms of patients' personally-tailored treatment plan based on daily feedback via IVR about patients' pedometer-measured step counts as well as their CBT skill practice and physical functioning. The AI algorithm the investigators will use is designed to be as efficient as possible, so that the system can learn what works best for a given patient based on the collective experience of other similar patients as well as the individual's own history. The investigator's hypothesis is that AI-CBT will result in pain-related functional outcomes that are no worse (and possibly better) than the standard approach, but by scaling back the intensity of contact that is not resulting in marginal gains in pain control, the AI-CBT approach will be significantly less costly in terms of therapy time. Secondary hypotheses are that AI-CBT will result in greater patient engagement and patient satisfaction. Outcomes will be measured at three and six months post recruitment and will include pain-related interference, treatment satisfaction, and treatment dropout.
- Conditions
- Back Pain
- Being tested
- Behavioral: AI-CBT, Behavioral: Standard Telephone CBT
- Keywords
- Cognitive Behavioral Therapy, Mobile Health Technology, Patient Care Management
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: AI-CBTBehavioural
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.
Behavioral: Standard Telephone CBTBehavioural
Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
| Study group | Role | What they receive |
|---|---|---|
| AI CBT | Experimental | 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. Receives: Behavioral: Behavioral: AI-CBT |
| Standard telephone CBT | Active comparator | Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook. Receives: Behavioral: Behavioral: Standard Telephone CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-related Disability
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.
Measured: 3 and 6 months post enrollment
Secondary outcomes (3)
Global Pain Intensity
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.
Measured: 3 and 6 months post enrollment
Pain-Related Interference
Pain-related interference was measured using the Brief Pain Inventory - Short Form (BPI). Scores range from 0-10, with higher scores indicating more interference.
Measured: 3 and 6 months post enrollment
Depression Symptom Severity
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.
Measured: 3 and 6 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start24 Jul 2017
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John D. Piette, PhD, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MIAlicia A. Heapy, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464449
- Sponsor's protocol ID
- IIR 13-350
- Acronym
- REACT (AI CBT)
- Status last verified
- Jul 2023
- First submitted
- 29 May 2015
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No/Undecided
Publications
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.
PubMed 35939288MacLean 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.
PubMed 36484691Mattocks 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.
PubMed 36527287Piette 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.
PubMed 27056770
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools
- ClinicalTrials.gov ID
- NCT02464449
- Acronym / sponsor ID
- REACT (AI CBT) / IIR 13-350
- Conditions
- Back Pain
- Keywords
- Cognitive Behavioral Therapy, Mobile Health Technology, Patient Care Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Posted 2 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate a new approach for back pain care management using artificial intelligence and evidence-based cognitive behavioral therapy (AI-CBT) so that services automatically adapt to each Veteran's unique needs, achieving outcomes as good as standard care but with less clinician time.
Detailed description
Cognitive behavioral therapy (CBT) is one of the most effective treatments for chronic back pain. However, only half of Veterans have access to trained CBT therapists, and program expansion is costly. Moreover, VA CBT programs consist of 10 weekly hour-long sessions delivered using an approach that is out-of-sync with stepped-care models designed to ensure that scarce resources are used as effectively and efficiently as possible. Data from prior CBT trials have documented substantial variation in patients' needs for extended treatment, and the characteristics of effective programs vary significantly. Some patients improve after the first few sessions while others need more extensive contact. After initially establishing a behavioral plan, still other Veterans may be able to reach behavioral and symptom goals using a personalized combination of manuals, shorter follow-up contacts with a therapist, and automated telephone monitoring and self-care support calls. In partnership with the National Pain Management Program, the investigators propose to apply state-of-the-art principles from "reinforcement learning" (a field of artificial intelligence or AI used successfully in robotics and on-line consumer targeting) to develop an evidence-based, personalized CBT pain management service that automatically adapts to each Veteran's unique and changing needs (AI-CBT). AI-CBT will use feedback from patients about their progress in pain-related functioning measured daily via pedometer step-counts to automatically personalize the intensity and type of patient support; thereby ensuring that scarce therapist resources are used as efficiently as possible and potentially allowing programs with fixed budgets to serve many more Veterans. The specific aims of the study are to: (1) demonstrate that AI-CBT has non-inferior pain-related outcomes compared to standard telephone CBT; (2) document that AI-CBT achieves these outcomes with more efficient use of scarce clinician resources as evidenced by less overall therapist time and no increase in the use of other VA health services; and (3) demonstrate the intervention's impact on proximal outcomes associated with treatment response, including program engagement, pain management skill acquisition, satisfaction with care, and patients' likelihood of dropout. The investigators will use qualitative interviews with patients, clinicians, and VA operational partners to ensure that the service has features that maximize scalability, broad scale adoption, and impact. 278 patients with chronic back pain will be recruited from the VA Connecticut Healthcare System and the VA Ann Arbor Healthcare System, and randomized to standard 10-sessions of telephone CBT versus AI-CBT. All patients will begin with weekly hour-long telephone counseling, but for patients in the AI-CBT group, those who demonstrate a significant treatment response will be stepped down through less resource-intensive alternatives to hour-long contacts, including: (a) 15 minute contacts with a therapist, and (b) CBT clinician feedback provided via interactive voice response calls (IVR). The AI engine will learn what works best in terms of patients' personally-tailored treatment plan based on daily feedback via IVR about patients' pedometer-measured step counts as well as their CBT skill practice and physical functioning. The AI algorithm the investigators will use is designed to be as efficient as possible, so that the system can learn what works best for a given patient based on the collective experience of other similar patients as well as the individual's own history. The investigator's hypothesis is that AI-CBT will result in pain-related functional outcomes that are no worse (and possibly better) than the standard approach, but by scaling back the intensity of contact that is not resulting in marginal gains in pain control, the AI-CBT approach will be significantly less costly in terms of therapy time. Secondary hypotheses are that AI-CBT will result in greater patient engagement and patient satisfaction. Outcomes will be measured at three and six months post recruitment and will include pain-related interference, treatment satisfaction, and treatment dropout.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI CBT | Experimental | Behavioral: Behavioral: AI-CBTAI 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. |
| Standard telephone CBT | Active comparator | Behavioral: Behavioral: Standard Telephone CBTControls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- COPD requiring oxygen
- Cancer requiring chemotherapy
- Currently receiving CBT
- Suicidality
- Receiving surgical tx related to back pain
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 |
|---|---|---|
| Behavioral: AI-CBTAI 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. | Behavioural | AI CBT |
| Behavioral: Standard Telephone CBTControls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook. | Behavioural | Standard telephone CBT |
Primary outcome
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 secondary outcomes
Global Pain Intensity
Time frame: 3 and 6 months post enrollment
Pain-Related Interference
Time frame: 3 and 6 months post enrollment
Depression Symptom Severity
Time frame: 3 and 6 months post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35939288Piette 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.
- Results publication: PubMed 36484691MacLean 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.
- Results publication: PubMed 36527287Mattocks 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.
- Results publication: PubMed 27056770Piette 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.
- Individual participant dataSharing planned: No. No/Undecided
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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.
John D. Piette, PhD principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
Alicia A. Heapy, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: AI-CBT and Behavioral: Standard Telephone CBT in people with Back Pain, run by VA Office of Research and Development 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 6 inclusion and 17 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 27 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 2 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain-related Disability (time frame: 3 and 6 months post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02464449, which also lists 4 linked publications.
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 27 Jul 2023.