AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in United States

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 groups in NCT02464449
Study groupRoleWhat they receive
AI CBTExperimentalAI 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 CBTActive comparatorControls 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted8 Jun 2015 (estimated)
  2. Study start24 Jul 2017
  3. Primary completion30 Apr 2020
  4. Study completion30 Apr 2020

Resources

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)
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
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 35939288
  • 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.

    PubMed 36484691
  • 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.

    PubMed 36527287
  • 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.

    PubMed 27056770

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in