Recruiting

Digital Tools

Sponsor:

AugMend Health Inc.

Code:

NCT07336537

Conditions

Chronic Pain

Mental Health Disorders

Behavioral Health Challenges

Ecological Momentary Assessment Best Practices

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital Biopsychosocial Conversational Data Collection Software

Standard Digital Questionnaire Data Collection

Study Details

Brief summary:

This research study is being conducted to evaluate digital software tools that collect health information through conversations. The study will test how acceptable, feasible, and usable these conversational software programs are for patients with chronic pain.

Purpose of the Study:

The goal is to understand whether digital conversational tools can effectively gather biopsychosocial information (biological, psychological, and social factors related to health) from patients experiencing chronic pain. Biopsychosocial information includes details about your physical symptoms, emotional well-being, social circumstances, and how these factors interact to affect your health. These digital tools are designed to have conversation-like interactions with patients to collect this comprehensive health data in a more natural and engaging way.

What Participation Involves:

If you join this study, you will interact with digital conversational software that will ask you questions about your health, pain experience, and related factors. The software is designed to communicate with you in a conversational manner, similar to talking with a healthcare provider, to gather information about your condition. You will be asked about various aspects of your chronic pain experience, including how it affects your daily life, your emotional state, and your social interactions.

Who Can Participate:

This study is looking for participants who have chronic pain conditions. Medical providers who treat patients with chronic pain are encouraged to refer eligible patients to this study. Healthcare providers interested in referring patients or learning more about the study can contact the study sponsor, AugMend Health Inc.

Why This Research Matters:

Chronic pain affects millions of people and understanding the full scope of how it impacts patients requires collecting detailed information about physical, psychological, and social factors. Traditional methods of collecting this information can be time-consuming and may not capture the complete picture. Digital conversational tools offer a potential new approach to gathering comprehensive health information in a more efficient and patient-friendly manner. This research will evaluate whether patients find these tools acceptable to use, whether they work practically in real-world clinical settings, and whether they are user-friendly and accessible for people with chronic pain.

Study Location:

The study is being conducted at AugMend Health in Cambridge, Massachusetts.

Study Sponsor:

This study is sponsored by AugMend Health Inc. Healthcare providers or potential participants who would like more information about the study or wish to make a referral can contact AugMend Health Inc.

Participation in this study is voluntary, and you can choose to stop participating at any time without affecting your regular medical care.

Conditions

Chronic Pain

Mental Health Disorders

Behavioral Health Challenges

Ecological Momentary Assessment Best Practices

Study ID

NCT07336537

Start date

Oct 3, 2025

Status verified date

Dec, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Feb 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults aged 18 years or older
  • Diagnosis of chronic pain (pain lasting 3 months or longer)
  • Able to read and understand English
  • Able to provide informed consent
  • Willing and able to complete study procedures either at home or at the MIT.nano Immersion Lab
  • Access to necessary technology for home-based participation (if assigned to home-based group), or ability to travel to the MIT.nano Immersion Lab (if assigned to laboratory-based group)
  • Cognitively able to interact with digital data collection software and provide feedback

Exclusion Criteria:

  • Under 18 years of age
  • Unable to provide informed consent
  • Non-English speaking
  • Acute pain only (pain lasting less than 3 months)
  • Cognitive impairment that would prevent meaningful interaction with data collection software or ability to provide valid feedback
  • Unable or unwilling to complete study procedures in assigned setting (home or laboratory)
  • Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with the participant's ability to complete study procedures

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Experimental Digital Biopsychosocial Data Collection Software

Participants in this arm will use digital software to provide biopsychosocial information about their chronic pain condition. The software will collect data about participants' pain experiences, physical functioning, emotional well-being, social circumstances, and other health-related factors.

Participants may complete study procedures at home or at the MIT.nano Immersion Lab depending on the technical requirements and study protocol. They will interact with the digital platform to provide comprehensive health information and will be asked to provide feedback on their experience with the data collection method.

This arm evaluates the acceptability (whether patients find the tool appropriate and are willing to use it), feasibility (whether it can be practically implemented in real-world settings), and usability (how easy and intuitive the tool is for patients) of the digital data collection approach.

active comparator: Control Standard Data Collection Method

Participants in this arm will use a standard method to provide biopsychosocial information about their chronic pain condition. They will provide data about their pain experiences, physical functioning, emotional well-being, social circumstances, and other health-related factors using conventional data collection approaches.

Participants may complete study procedures at home or at designated study locations depending on the study protocol. They will provide comprehensive health information through the assigned data collection method and will be asked to provide feedback on their experience.

This arm serves as a comparison group to evaluate the acceptability (whether patients find the method appropriate and are willing to use it), feasibility (whether it can be practically implemented in real-world settings), and usability (how easy and intuitive the method is for patients) of standard data collection approaches.

Interventions

Digital Biopsychosocial Conversational Data Collection Software

This intervention involves participants interacting with digital conversational software that uses artificial intelligence and natural language processing to collect biopsychosocial health information. The software engages participants in dialogue-based interactions, asking questions about their chronic pain experience, physical functioning, emotional well-being, and social circumstances.

The conversational interface adapts to participant responses, can ask follow-up questions for clarification, and creates an interactive experience that mimics clinical interviews. Some implementations may utilize virtual reality (VR) environments to create immersive data collection experiences at the MIT.nano Immersion Lab.

Participants interact with the software either at home using provided devices or at the MIT.nano Immersion Lab. The AI-driven platform standardizes data collection while maintaining conversational flexibility, collecting comprehensive biopsychosocial data through natural language

Standard Digital Questionnaire Data Collection

This intervention involves participants completing standard digital questionnaires or surveys to provide biopsychosocial health information. Participants respond to predetermined, fixed-format questions about their chronic pain experience, physical functioning, emotional well-being, and social circumstances.

The data collection uses conventional electronic forms or surveys with static question sets that do not adapt based on participant responses. Questions are presented in a standard sequence without conversational elements or follow-up prompts. This represents traditional electronic data collection methods commonly used in clinical and research settings.

Participants complete the questionnaires either at home using their own devices or provided equipment, or at designated study locations. This method provides a comparison baseline against which to evaluate newer digital data collection approaches, representing current standard practice for gathering patient-reported health informat

Primary outcome measure

  • Acceptability [ Time Frame: Assessed immediately after completion of data collection procedures (typically within 1-2 weeks of enrollment) ]
  • Usability [ Time Frame: Assessed immediately after completion of data collection procedures (typically within 1-2 weeks of enrollment) ]
  • Technical Feasibility [ Time Frame: Assessed throughout study participation (typically within 1-2 weeks of enrollment) ]
  • Implementation Feasibility [ Time Frame: Assessed immediately after completion of data collection procedures (typically within 1-2 weeks of enrollment) ]
  • Data Collection Feasibility [ Time Frame: Assessed at completion of all data collection procedures (typically within 1-2 weeks of enrollment) ]

Central Contacts and Locations

Central contacts

Mark Ruchman, MD

+1 (203) 598-9557mruchman@augmend.health

Study Coordinator

amurnane@augmend.health

Locations

AugMend Health at MIT.nano Immersion Lab

Recruiting

Cambridge, Massachusetts, United States, 02139

Contacts

Abigail Murnane

amurnane@augmend.health

Sacha Moreau, MA

smoreau@augmend.health

Principal Investigator:

Mark Ruchman, MD

More Information

Sponsor

AugMend Health Inc.

Last update posted

Jan 13, 2026

Last verified

Dec, 2025

Keywords

  • Chronic Pain
  • Behavioral Health
  • Mental Health
  • Technology
  • Assessment
  • Data Collection
  • Biopsychosocial
  • Digital Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AugMend Health Inc. on 2026-01-13.