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New treatment option for Major Depression
Official title Modular Intervention for Depression Study
ClinicalTrials.gov ID: NCT07380451
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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)...
You likely can't join if
- 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).
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Santiago, Chile
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santiago, Chile. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.