NCT02464449

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
2.1 years until next milestone

Study Start

First participant enrolled

July 24, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 2, 2021

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2.8 years

First QC Date

May 29, 2015

Results QC Date

May 5, 2021

Last Update Submit

July 19, 2023

Conditions

Back Pain

Keywords

Cognitive Behavioral TherapyMobile Health TechnologyPatient Care Management

Outcome Measures

Primary Outcomes (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.

    3 and 6 months post enrollment

Secondary Outcomes (3)

  • Global Pain Intensity

    3 and 6 months post enrollment

  • Pain-Related Interference

    3 and 6 months post enrollment

  • Depression Symptom Severity

    3 and 6 months post enrollment

Study Arms (2)

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.

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.

Behavioral: Behavioral: Standard Telephone CBT

Interventions

Behavioral: AI-CBTBEHAVIORAL

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.

AI CBT
Behavioral: Standard Telephone CBTBEHAVIORAL

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

Standard telephone CBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

Related Publications (4)

  • 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.

    PMID: 35939288RESULT

  • 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.

    PMID: 36484691RESULT

  • 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.

    PMID: 36527287RESULT

  • 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.

    PMID: 27056770RESULT

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. John Piette, PhD
Organization
Ann Arbor VA Healthcare System
jpiette@umich.edu
734-845-3626

Study Officials

  • 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

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2015

First Posted

June 8, 2015

Study Start

July 24, 2017

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

July 27, 2023

Results First Posted

September 2, 2021

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

No/Undecided

Locations

US(2)