Personalized modular psychotherapy for depression complicated by personality or trauma-related problems
Modular Optimization of Psychotherapy for Individuals With Depression Complicated by Personality Dysfunction and Complex Trauma: A Pilot Study in the Chilean Public Health System
This trial tests whether a personalized, algorithm-guided modular psychotherapy helps adults (18–65) in Chile with major depression plus personality dysfunction or early-life trauma more than usual individual therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 5 sites (Santiago and 4 other locations) |
| Trial ID | NCT07380451 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 150 adults (18–65) receiving care in Chilean public community mental health centers and randomize them to algorithm-based modular psychotherapy or usual individual psychotherapy. The experimental arm delivers a core evidence-based depression treatment plus additional short modules selected by an algorithm based on each participant's baseline profile (emotion regulation, interpersonal sensitivity, social functioning, self-concept, and trauma history). Therapies are delivered weekly by trained clinicians and outcomes include depressive symptom reduction and remission, improvements in emotional regulation, interpersonal and self-related functioning, and changes observed in daily life. The program is designed to be feasible within routine public mental health services and requires participants to have a smartphone for digital data collection and contact.
Who should consider this trial
Good fit: Adults aged 18–65 receiving care at participating Chilean public community mental health centers who have major depressive disorder complicated by personality dysfunction and/or significant early-life adversity, meet the study screening cutoffs, and own a smartphone.
Not a fit: People whose depression is not accompanied by personality dysfunction or significant early-life trauma, those outside the 18–65 age range, patients not treated at the participating centers, or those without a smartphone or ability to attend weekly sessions are unlikely to benefit from this specific program.
Why it matters
Potential benefit: If successful, this approach could increase remission rates and improve everyday emotional and interpersonal functioning by tailoring therapy to the patient's specific personality and trauma-related needs within public mental health settings.
How similar studies have performed: Modular, algorithm-guided psychotherapy approaches have shown promise in other clinical contexts, but applying a tailored modular program specifically for depression complicated by personality dysfunction and early-life trauma in Chilean public clinics is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Current diagnosis of major depressive disorder, defined as: * Positive diagnosis on the MINI diagnostic interview, and * PHQ-9 score greater than 10 * Evidence of personality dysfunction, defined as a score above the cutoff on the Level of Personality Functioning Scale-Brief Form (LPFS-BF 2.0). * History of moderate to severe early life adversity, defined as elevated scores on at least one scale of the Childhood Trauma Questionnaire (CTQ), and/or clinically significant alterations in self-organization. * Presence of at least one elevated domain of alteration of self-organization, including emotion regulation difficulties, interpersonal sensitivity, and/or interpersonal functioning problems, as assessed by standardized self-report measures (DERS, A-RSQ, OQ-45-IR). * Receiving care at a participating public community mental health center in Chile. * Ownership of a smartphone (Android or iOS) with internet access and an active data plan. * Ability to provide written informed consent. Exclusion Criteria: * Acute suicide risk requiring immediate intensive intervention, as assessed by the MINI. * Any severe psychiatric disorder other than major depressive disorder that is the primary clinical diagnosis, including: * Schizophrenia or other psychotic disorders * Bipolar I disorder * Severe substance use disorder, active within the past 6 months. * Diagnosis of post-traumatic stress disorder (PTSD) meeting full diagnostic criteria, as assessed by standardized instruments (ITEM and ITQ). * Meeting diagnostic criteria for: * Antisocial personality disorder (two or more criteria), or * Borderline personality disorder with more than three diagnostic criteria * Severe medical, cognitive, or psychosocial condition that would interfere with participation in weekly psychotherapy. * Concurrent participation in another active psychotherapy or initiation/change of psychotropic medication during the study period, except for: * Stable antidepressant treatment * Medications prescribed for sleep * Benzodiazepines used only on an as-needed (PRN) basis. * Inability to comply with study procedures or assessments.
Where this trial is running
Santiago and 4 other locations
- Cdt Casr — Santiago, Chile (Recruiting)
- COSAM La Bandera — Santiago, Chile (Active_not_recruiting)
- COSAM La Granja — Santiago, Chile (Recruiting)
- COSAM La Pintana — Santiago, Chile (Recruiting)
- COSAM Rinconada — Santiago, Chile (Recruiting)
Study contacts
- Study coordinator: Alex J Behn, PhD
- Email: albehn@uc.cl
- Phone: +56942152484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.