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NCT Number: NCT07776600

VETERANS AFFAIRS AUGUSTA

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

My AI Companion

Behavioral

My AI Companion is an automated, text/telephone-delivered chatbot designed to support chronic pain self-management among high-utilizing Veterans.

Primary outcomes

  1. Acceptability

    Time frame: baseline, 3, 6, and 12 months

    Net Promoter Score

  2. Feasibility of Engagement

    Time frame: baseline, 3, 6, and 12 months

    Measure feasibility through enrollment, retention, and chatbot engagement data (e.g., number of interactions, session duration).

Other outcomes

  1. Pain intensity, Enjoyment of life, General activity

    Time frame: baseline, 3, 6, and 12 months

    PEG Scale (Pain intensity, Enjoyment of life, General activity)

  2. Pain Interference

    Time frame: baseline, 3, 6, and 12 months

    PROMIS Pain Interference Short Form

  3. Loneliness

    Time frame: baseline, 3, 6, and 12 months

    UCLA Loneliness Scale (short form)

  4. Veteran-specific health-related quality of life

    Time frame: baseline, 3, 6, and 12 months

    VR-12 (Veteran-specific health-related quality of life)

  5. Depression and Anxiety

    Time frame: baseline, 3, 6, and 12 months

    PROMIS Depression and Anxiety Short Forms

  6. Sleep Disturbance Short Form

    Time frame: baseline, 3, 6, and 12 months

    PROMIS Sleep Disturbance Short Form

  7. Self-Efficacy for Managing Chronic Disease Scale

    Time frame: baseline, 3, 6, and 12 months

    Self-Efficacy for Managing Chronic Disease Scale

  8. Alcohol and drug use

    Time frame: baseline, 3, 6, and 12 months

    AUDIT-C and DAST-10 (for alcohol and drug use)

Study contacts

Contact information is provided by the study sponsor or research team.

Henrik Scheel

CONTACT

[email protected]

650 804-5000

Sponsors and collaborators

Lead sponsor

Companion IQ, Inc

Industry

Collaborators

  • VA Augusta Health Care System

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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