Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07380451
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07380451
Study Brief:
Protocol Section:
NCT07380451