Chronic PainNCT07776600
VETERANS AFFAIRS AUGUSTA
A study testing My AI Companion in people with Chronic Pain, run by Companion IQ, Inc at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- My AI Companion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Augusta Health Care System
Augusta, Georgia, 30904
Lisa Parker, MD, (706) 733-0188, lisa.parker1@va.gov
Raji Ponnala, Rajeshwari.Ponnala@va.gov
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- My AI Companion
- Keywords
- Pain
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My AI CompanionBehavioural
My AI Companion is an automated, text/telephone-delivered chatbot designed to support chronic pain self-management among high-utilizing Veterans.
| Study group | Role | What they receive |
|---|---|---|
| My AI Companion | Experimental | Not described Receives: Behavioral: My AI Companion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Net Promoter Score
Measured: 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).
Measured: baseline, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Aug 2026
- Primary completion1 Aug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Companion IQ, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VA Augusta Health Care System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776600
- Sponsor's protocol ID
- Veterans Affairs: Augusta
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be shared when appropriate approvals are in place and applicable privacy and data-sharing requirements have been met
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Text/Telephone-Delivered Chatbot Intervention for Chronic Pain Management Among High- Utilizing Veterans
- ClinicalTrials.gov ID
- NCT07776600
- Acronym / sponsor ID
- Veterans Affairs: Augusta
- Conditions
- Chronic Pain
- Keywords
- Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Companion IQ, IncIndustry (pharma, biotech, devices)
- Collaborators
- VA Augusta Health Care System
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| My AI Companion | Experimental | Behavioral: My AI Companion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Individuals will be excluded from the study if they:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My AI CompanionMy AI Companion is an automated, text/telephone-delivered chatbot designed to support chronic pain self-management among high-utilizing Veterans. | Behavioural | My AI Companion |
Primary outcome
Acceptability
Time frame: baseline, 3, 6, and 12 months
Net Promoter Score
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No. IPD will only be shared when appropriate approvals are in place and applicable privacy and data-sharing requirements have been met
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My AI Companion in people with Chronic Pain, run by Companion IQ, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henrik Scheel (650 804-5000, henrik@companioniq.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: baseline, 3, 6, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.