Using Data Science To Center Patient Perspectives in Mechanism Discovery (NCT06233968) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Using Data Science To Center Patient Perspectives in Mechanism Discovery
United States33 participantsStarted 2024-03-19
Plain-language summary
Including patient perspectives when developing new therapy interventions is crucial because it can help to understand response heterogeneity and promote engagement. Yet, analyzing patient interview data is difficult and time-consuming. This study aims to explore the potential for natural language processing and deep learning to analyze patient interviews and identify potential ways in which therapy leads to psychological change. This study will recruit participants from an existing clinical service that offers a 16-week online group therapy model (and adjunct individual therapy sessions) called Program for Alleviating and Resolving Trauma and Stress (PARTS) based on a therapy called Internal Family Systems (IFS). The investigators will use a mixed methods approach, applying natural language processing and deep learning to develop models that identify potential mechanisms of change. These models will be based on patient perspectives of psychological change, as expressed in interviews, and be compared to models based on clinical measures.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Must be enrolled in the clinical service offering online PARTS group and approved and confirmed to start by the clinical team.
Have sufficient English fluency and literacy skills to understand the consent process, procedures and questionnaires and have the ability to provide written informed consent.
Have access to the internet and an electronic device with adequate data capacity; to complete questionnaires online and participate in two online video interviews.
Must be willing to complete online computerized assessments both at baseline and post-intervention; and participate in two, one-hour videotaped interviews one at baseline and one 2-4 weeks post-intervention.
Exclusion Criteria:
Inability to complete an informed consent assessment AND/OR inability to complete baseline study assessment procedures (due to cognitive deficit, non-proficiency in English literacy, or any other reason).
Expected medical hospitalization in 24 weeks from the date of enrollment.
Expected incarceration in 24 weeks from the date of enrollment.
Individuals who are pregnant with a due date within 24 weeks after study consent.
Insufficient internet connection to conduct online interviews or computerized assessments.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.