Using Data Science To Center Patient Perspectives in Mechanism Discovery

NCT06233968 | Active Not Recruiting

• 1 other identifier: 13664
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder; Complex Post-Traumatic Stress Disorder

Keywords

natural language processing; machine learning; Internal Family Systems

Outcome Measures

Primary Outcomes (1)

• Similarity of topics and mechanism identification

  Similarity of topics obtained from interview data using language processing tools to those classified by human coders and identification of mechanisms from predictive models with language processing derived features.

  24 weeks

Secondary Outcomes (1)

• Comparable mechanism identification and performance

  24 weeks

Other Outcomes (2)

• PTSD Symptom Severity Changes

  20 weeks

• PTSD and Complex PTSD Symptom Severity Changes

  20 weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• Foundation for Self Leadership: collaborator

Study Sites (1)

Cambridge Health Alliance

Malden, Massachusetts, 02148, United States

Location

Related Publications (4)

• Spoont MR, Murdoch M, Hodges J, Nugent S. Treatment receipt by veterans after a PTSD diagnosis in PTSD, mental health, or general medical clinics. Psychiatr Serv. 2010 Jan;61(1):58-63. doi: 10.1176/ps.2010.61.1.58.

  PMID: 20044419 BACKGROUND

• 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.

  PMID: 18573035 BACKGROUND

• Adams-Campbell LL, Ahaghotu C, Gaskins M, Dawkins FW, Smoot D, Polk OD, Gooding R, DeWitty RL. Enrollment of African Americans onto clinical treatment trials: study design barriers. J Clin Oncol. 2004 Feb 15;22(4):730-4. doi: 10.1200/JCO.2004.03.160.

  PMID: 14966098 BACKGROUND

• Erves JC, Mayo-Gamble TL, Malin-Fair A, Boyer A, Joosten Y, Vaughn YC, Sherden L, Luther P, Miller S, Wilkins CH. Needs, Priorities, and Recommendations for Engaging Underrepresented Populations in Clinical Research: A Community Perspective. J Community Health. 2017 Jun;42(3):472-480. doi: 10.1007/s10900-016-0279-2.

  PMID: 27812847 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Zev Schuman-Olivier, MD

  Center for Mindfulness and Compassion, Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

• Dilara Ally, PhD

  Center for Mindfulness and Compassion, Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: January 31, 2024
• Study Start: March 19, 2024
• Primary Completion: May 5, 2025
• Study Completion (Estimated): December 5, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)