Personalized modular psychotherapy for depression complicated by personality or trauma-related problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cdt Casr
  Santiago, Chile Recruiting
• COSAM La Granja
  Santiago, Chile Recruiting
• COSAM La Pintana
  Santiago, Chile Recruiting
• COSAM Rinconada
  Santiago, Chile Recruiting
• COSAM La Bandera
  Santiago, Chile Active not recruiting

Study contacts

• Study coordinator: Alex J Behn, PhD
• Email: albehn@uc.cl
• Phone: +56942152484

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.