💬In plain words
What the trial is, and whether it could suit you
The goal of this psychotherapy clinical trial is to evaluate whether a algorithm-based personalized modular psychotherapy is more effective than usual individual psychotherapy in treating major depressive disorder complicated by personality dysfunction and/or complex trauma in adults aged 18 to 65 receiving care in the Chilean public mental health system.
The main questions it aims to answer are:
* Does algorithm-based modular psychotherapy lead to greater clinically significant reduction and remission of depressive symptoms compared to usual psychotherapy?
* Does algorithm-based modular psychotherapy lead to greater improvement in emotional regulation, interpersonal functioning, and self-related functioning, including changes observed in daily life?
Researchers will compare algorithm-based modular psychotherapy to usual individual psychotherapy provided in public community mental hea
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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