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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard telephone CBT | Active Comparator | Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral: AI-CBT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 and 6 months post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 and 6 months post enrollment |
| Pain-Related Interference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John D. Piette, PhD | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Alicia A. Heapy, PhD | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516-2770 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35939288 | Result | 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. | |
| 36484691 |
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No/Undecided
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Behavioral: AI-CBT: 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. |
| FG001 | Standard Telephone CBT | Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook. Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Behavioral: AI-CBT: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number analyzed in rows differs because some participants did not complete the questionnaire at all time points. | Posted | Mean | Standard Deviation | units on a scale | 3 and 6 months post enrollment |
|
During the intervention period (approximately 10 weeks of the standard telephone CBT or the AI CBT).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Behavioral: AI-CBT: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unrelated to study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Piette, PhD | Ann Arbor VA Healthcare System | 734-845-3626 | jpiette@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2018 | Aug 5, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Behavioral: Standard Telephone CBT | Behavioral | Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook. |
|
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 | 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 |
| VA Ann Arbor Healthcare System, Ann Arbor, MI |
| Ann Arbor |
| Michigan |
| 48105-2303 |
| United States |
| Result |
| 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. |
| 36527287 | Result | 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. |
| 27056770 | Result | 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. |
| BG001 | Standard Telephone CBT | Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook. Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Standard Telephone CBT | Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook. Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook. |
|
|
| Secondary | 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. | The number analyzed in rows differs because some participants did not complete the questionnaire at all time points. | Posted | Mean | Standard Deviation | units on a scale | 3 and 6 months post enrollment |
|
|
|
| Secondary | 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. | The number analyzed in rows differs because some participants did not complete the questionnaire at all time points. | Posted | Mean | Standard Deviation | units on a scale | 3 and 6 months post enrollment |
|
|
|
| Secondary | 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. | The number analyzed in rows differs because some participants did not complete the questionnaire at all time points. | Posted | Mean | Standard Deviation | units on a scale | 3 and 6 months post enrollment |
|
|
|
| 0 |
| 166 |
| 5 |
| 166 |
| 0 |
| 166 |
| EG001 | Standard Telephone CBT | Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook. Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook. | 0 | 112 | 3 | 112 | 0 | 112 |
|
| Stroke | Vascular disorders | Non-systematic Assessment | Unrelated to study |
|
| Infection | Infections and infestations | Non-systematic Assessment | Unrelated to study |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment | Unrelated to study |
|
| Emesis | Gastrointestinal disorders | Non-systematic Assessment | Unrelated to study |
|
| Heat stroke | General disorders | Non-systematic Assessment | Unrelated to study |
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| 6 months post enrollment |
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| 6 months post enrollment |
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| 6 months post enrollment |
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