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Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02464449
Acronym
REACT (AI CBT)
Enrollment
278
Registered
2015-06-08
Start date
2017-07-24
Completion date
2020-04-30
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain

Keywords

Cognitive Behavioral Therapy, Mobile Health Technology, Patient Care Management

Brief 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.

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.

Interventions

BEHAVIORALBehavioral: 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.

BEHAVIORALBehavioral: Standard Telephone CBT

Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain-related Disability3 and 6 months post enrollmentThe 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.

Secondary

MeasureTime frameDescription
Global Pain Intensity3 and 6 months post enrollmentAn 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.
Pain-Related Interference3 and 6 months post enrollmentPain-related interference was measured using the Brief Pain Inventory - Short Form (BPI). Scores range from 0-10, with higher scores indicating more interference.
Depression Symptom Severity3 and 6 months post enrollmentDepression 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
166
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.
112
Total278

Baseline characteristics

CharacteristicTotalAI CBTStandard Telephone CBT
Age, Continuous63.9 years
STANDARD_DEVIATION 12.2
62.8 years
STANDARD_DEVIATION 13.1
65.6 years
STANDARD_DEVIATION 10.6
Depression Symptom Severity6.5 units on a scale
STANDARD_DEVIATION 5.1
6.3 units on a scale
STANDARD_DEVIATION 5.2
6.6 units on a scale
STANDARD_DEVIATION 5.1
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants6 Participants7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
265 Participants160 Participants105 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Global Pain Intensity6.2 units on a scale
STANDARD_DEVIATION 1.5
6.2 units on a scale
STANDARD_DEVIATION 1.6
6.3 units on a scale
STANDARD_DEVIATION 1.4
Pain-related Disability13.6 units on a scale
STANDARD_DEVIATION 4.1
13.7 units on a scale
STANDARD_DEVIATION 4.1
13.5 units on a scale
STANDARD_DEVIATION 4.2
Pain-Related Interference4.9 units on a scale
STANDARD_DEVIATION 2.1
4.9 units on a scale
STANDARD_DEVIATION 2.2
5.0 units on a scale
STANDARD_DEVIATION 2.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
37 Participants27 Participants10 Participants
Race (NIH/OMB)
More than one race
15 Participants8 Participants7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
225 Participants131 Participants94 Participants
Sex: Female, Male
Female
30 Participants21 Participants9 Participants
Sex: Female, Male
Male
248 Participants145 Participants103 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1660 / 112
other
Total, other adverse events
0 / 1660 / 112
serious
Total, serious adverse events
5 / 1663 / 112

Outcome results

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.

Time frame: 3 and 6 months post enrollment

Population: The number analyzed in rows differs because some participants did not complete the questionnaire at all time points.

ArmMeasureGroupValue (MEAN)Dispersion
AI CBTPain-related Disability3 months post enrollment11.0 units on a scaleStandard Deviation 6.1
AI CBTPain-related Disability6 months post enrollment11.0 units on a scaleStandard Deviation 5.9
Standard Telephone CBTPain-related Disability3 months post enrollment11.3 units on a scaleStandard Deviation 5.1
Standard Telephone CBTPain-related Disability6 months post enrollment12.6 units on a scaleStandard Deviation 5.3
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.

Time frame: 3 and 6 months post enrollment

Population: The number analyzed in rows differs because some participants did not complete the questionnaire at all time points.

ArmMeasureGroupValue (MEAN)Dispersion
AI CBTDepression Symptom Severity3 months post enrollment6.7 units on a scaleStandard Deviation 5.3
AI CBTDepression Symptom Severity6 months post enrollment6.8 units on a scaleStandard Deviation 5.1
Standard Telephone CBTDepression Symptom Severity3 months post enrollment6.7 units on a scaleStandard Deviation 5.1
Standard Telephone CBTDepression Symptom Severity6 months post enrollment7.5 units on a scaleStandard Deviation 6
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.

Time frame: 3 and 6 months post enrollment

Population: The number analyzed in rows differs because some participants did not complete the questionnaire at all time points.

ArmMeasureGroupValue (MEAN)Dispersion
AI CBTGlobal Pain Intensity3 months post enrollment5.1 units on a scaleStandard Deviation 2
AI CBTGlobal Pain Intensity6 months post enrollment5.3 units on a scaleStandard Deviation 1.9
Standard Telephone CBTGlobal Pain Intensity3 months post enrollment5.0 units on a scaleStandard Deviation 1.8
Standard Telephone CBTGlobal Pain Intensity6 months post enrollment5.7 units on a scaleStandard Deviation 1.9
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.

Time frame: 3 and 6 months post enrollment

Population: The number analyzed in rows differs because some participants did not complete the questionnaire at all time points.

ArmMeasureGroupValue (MEAN)Dispersion
AI CBTPain-Related Interference3 months post enrollment3.9 units on a scaleStandard Deviation 2.4
AI CBTPain-Related Interference6 months post enrollment3.9 units on a scaleStandard Deviation 2.3
Standard Telephone CBTPain-Related Interference3 months post enrollment3.8 units on a scaleStandard Deviation 2.1
Standard Telephone CBTPain-Related Interference6 months post enrollment4.5 units on a scaleStandard Deviation 2.6

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026