Clinical trial NCT06233968: Using Data Science To Center Patient Perspectives in Mechanism Discovery
Official title: Using Data Science To Center Patient Perspectives In Psychological Mechanism Discovery and Intervention Development
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Posttraumatic Stress Disorder
Complex Post-Traumatic Stress Disorder
Keywords: natural language processing
machine learning
Internal Family Systems
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: Foundation for Self Leadership
First posted: 2024-01-31
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from a community-based clinical service called Program For Alleviating and Resolving Trauma and Stress (PARTS) service within Cambridge Health Alliance (CHA) that offers a 16-week, live-online group therapy model based on Internal Family Systems.

Brief 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.

Detailed description: Demand for cost-effective, novel, scalable trauma-focused interventions is high. Prevalence rates of posttraumatic stress disorder (PTSD) and Complex PTSD in US community mental health clinics are estimated to be as high as 50%. Yet response heterogeneity to PTSD interventions remains high, with non-response rates reaching 50-60% and dropout rates for traditional interventions (i.e., cognitive behavioral, exposure therapies) at 30-40%. Moreover, research populations in typical stepwise, efficacy-driven clinical research trials are often characterized by strict exclusion criteria and low representation from underrepresented communities. The homogeneous nature of efficacy-based research populations creates an incomplete picture, especially in public sector and community-based mental health facilities. Studies have suggested not only does this homogeneity limit effectiveness across diverse populations, but may contribute to exacerbating health disparities.

Engaging patient perspectives is crucial to research because it can provide insight into response heterogeneity and engagement, ultimately leading to an understanding of mechanisms and creating more patient-centered interventions. One way to center the patient's voice and increase the potential of identifying unique mechanisms of change for a novel therapy, is to use qualitative interviews because it directly accesses the lived experience and its context. Despite the potential benefits of utilizing qualitative data in stepwise randomized control trials, several obstacles persist, including resource constraints, the inability to quantify interactive elements, and concerns regarding the practical value of the gathered information. Innovative methods that reliably and rapidly extract value-laden, relevant themes, and discern non-verbal conversational elements may facilitate the integration of patient experience and inclusion of their perspectives in clinical intervention trials.

This single-arm study aims to evaluate the feasibility of using natural language processing (NLP) and deep learning to identify potential mechanisms of PTSD symptom change from patient interviews. The study will utilize ongoing cohorts from a clinical service that offers a 16-week, live-online group therapy model (and adjunct individual therapy sessions) called Program For Alleviating And Resolving Trauma and Stress (PARTS) that uses the IFS model. The investigators will use a convergent mixed methods approach applying machine learning and natural language processing to develop models that identify potential mechanisms of change.

Analysis: The investigators will use several different methods to develop our models including Latent Dirichlet Allocation, pre-trained language models, transfer learning (recurrent neural networks, generative adversarial network), and penalized regression-based models. These models will use data derived from patient perspectives of psychological change, as expressed in interviews, and will be compared to models derived from clinical measures. The study will use standard performance metrics and cross-validation scores to evaluate comparative performance of the models. As an exploratory aim, the study will evaluate the feasibility of using features derived from language processing models and clinical measures to predict individual therapy visits post-intervention. The exploratory data will also include structured clinical data, social determinants of health, and therapy-based utilization (dates, provider type, length).

Anticipated results: The development of two validated models: one derived from patient interview data and the other based on clinical measures to comprehensively identify mechanisms of change from group-based therapy models of IFS for PTSD.

Eligibility criteria: 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.

Primary outcomes:
measure: Similarity of topics and mechanism identification
timeFrame: 24 weeks
Secondary outcomes:
measure: Comparable mechanism identification and performance
timeFrame: 24 weeks
Other outcomes:
measure: PTSD Symptom Severity Changes
timeFrame: 20 weeks
measure: PTSD and Complex PTSD Symptom Severity Changes
timeFrame: 20 weeks
Locations:
city: Malden
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Center for Mindfulness and Compassion, Cambridge Health Alliance
name: Zev Schuman-Olivier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Mindfulness and Compassion, Cambridge Health Alliance
name: Dilara Ally, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Schottenbauer MA, Glass CR, Arnkoff DB, Tendick V, Gray SH. Nonresponse and dropout rates in outcome studies on PTSD: review and methodological considerations. Psychiatry. 2008 Summer;71(2):134-68. doi: 10.1521/psyc.2008.71.2.134.
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