VETERANS AFFAIRS AUGUSTA

Evaluating the Effectiveness of a Text/Telephone-Delivered Chatbot Intervention for Chronic Pain Management Among High- Utilizing Veterans

Chronic pain is a prevalent and debilitating condition among Veterans, often accompanied by depression, anxiety, sleep disturbances, and social isolation. Despite the availability of behavioral interventions many Veterans-particularly those with high in-person healthcare utilization-face barriers to accessing non-pharmacological pain management strategies. These barriers include limited clinician availability, geographic constraints, and digital exclusion among older or underserved populations.

This study aims to evaluate the feasibility, acceptability, and preliminary impact of My AI Companion, an automated, text/telephone-delivered chatbot designed to support chronic pain self-management among high-utilizing Veterans. The intervention offers a low-barrier approach to promoting symptom tracking, patient activation, and engagement in coping strategies-without requiring Internet access or clinician time.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: My AI Companion

Detailed Description

This is a prospective cohort study with a retrospective matched comparison group. We will enroll 200 Veterans receiving care at VA Augusta Health Care System who meet criteria for high in-person healthcare utilization and have a diagnosis of chronic pain. One hundred participants will use the chatbot over a 12-month period and complete assessments at baseline, 3, 6, and 12 months. Primary outcomes include pain interference (PEG Scale), quality of life (VR-12), patient activation (PAM), self-efficacy, depression and anxiety symptoms (PROMIS), sleep disturbance (PROMIS), loneliness (UCLA), and substance use (AUDIT-C, DAST-10). We will also collect data on employment, caregiving roles, and opioid prescriptions. A retrospective comparison group will be identified from medical records to assess relative changes in healthcare utilization. The remaining 100 participants will act as the comparison group in this study is primarily identified through retrospective chart data, we will proactively invite a subset of these Veterans to complete the same self-reported measures as the intervention group (e.g., PEG, VR-12, PROMIS Depression/Anxiety, Sleep, Self-Efficacy, UCLA Loneliness, AUDIT-C, and DAST- 10). This approach will strengthen our ability to compare patient-reported outcomes across groups and provide valuable insights into the impact of the chatbot intervention. We will identify Veterans in the comparison group based on matched characteristics (e.g., high in-person healthcare utilization, chronic pain diagnosis, and demographic/clinical factors) and invite them to participate in survey assessments at baseline, 3, 6, and 12 months. Outreach will include an initial letter or email invitation explaining the study purpose, eligibility criteria, and procedures, followed by phone calls from the research team to answer questions, obtain consent, and support survey completion.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henrik Scheel; Phone Number: 650 804-5000; Email: henrik@companioniq.org

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30904
      • Recruiting
      • VA Augusta Health Care System
      • Contact: Lisa Parker, MD; Phone Number: (706) 733-0188; Email: lisa.parker1@va.gov
      • Contact: Raji Ponnala; Email: Rajeshwari.Ponnala@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:Participants must meet all of the following eligibility criteria to be enrolled in the study:

• Be a Veteran receiving care at the VA Augusta Health Care System Pain Medicine Service.
• Be aged 18 or older.
• Have a documented diagnosis of chronic pain (defined as pain persisting longer than 3 months).
• Be classified as a high utilizer of VA in-person outpatient services, defined as having 4 or more in-person primary care, behavioral health, or pain-related visits within the past 6 months.
• Be English-speaking.
• Have access to a telephone (landline or cell phone).
• Have capacity to provide informed consent.

Exclusion Criteria:

• Individuals will be excluded from the study if they:

  • Have moderate to severe cognitive impairment that would interfere with the ability to engage with a text/telephone-based chatbot (as determined through medical record review or clinical judgment).
  • Have active psychosis or acute psychiatric instability (e.g., recent psychiatric hospitalization in the past month) that would impair study participation.
  • Are enrolled in another conflicting behavioral intervention study.
  • Are non-English speaking, due to the current availability of the chatbot only in English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: My AI Companion	Behavioral: My AI Companion; My AI Companion is an automated, text/telephone-delivered chatbot designed to support chronic pain self-management among high-utilizing Veterans.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Net Promoter Score	baseline, 3, 6, and 12 months
Feasibility of Engagement	Measure feasibility through enrollment, retention, and chatbot engagement data (e.g., number of interactions, session duration).	baseline, 3, 6, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity, Enjoyment of life, General activity	PEG Scale (Pain intensity, Enjoyment of life, General activity)	baseline, 3, 6, and 12 months
Pain Interference	PROMIS Pain Interference Short Form	baseline, 3, 6, and 12 months
Loneliness	UCLA Loneliness Scale (short form)	baseline, 3, 6, and 12 months
Veteran-specific health-related quality of life	VR-12 (Veteran-specific health-related quality of life)	baseline, 3, 6, and 12 months
Depression and Anxiety	PROMIS Depression and Anxiety Short Forms	baseline, 3, 6, and 12 months
Sleep Disturbance Short Form	PROMIS Sleep Disturbance Short Form	baseline, 3, 6, and 12 months
Self-Efficacy for Managing Chronic Disease Scale	Self-Efficacy for Managing Chronic Disease Scale	baseline, 3, 6, and 12 months
Alcohol and drug use	AUDIT-C and DAST-10 (for alcohol and drug use)	baseline, 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Companion IQ, Inc
• Collaborators: VA Augusta Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: August 7, 2026
• First Submitted That Met QC Criteria: August 17, 2026
• First Posted (Actual): August 20, 2026

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Chronic Pain
• Other Study ID Numbers: Veterans Affairs: Augusta

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will only be shared when appropriate approvals are in place and applicable privacy and data-sharing requirements have been met

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No