Modular Intervention for Depression Study

ConditionMajor Depression

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorPontificia Universidad Catolica de Chile

About this trial

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 health centers to see if the modular, personalized approach results in better clinical outcomes, stronger therapeutic alliance, and higher treatment satisfaction.

Participants will:

* Be randomly assigned to receive either algorithm-based modular psychotherapy or usual individual psychotherapy * Attend weekly individual psychotherapy sessions * Complete structured diagnostic interviews and self-report questionnaires before, during, and after treatment * Provide brief daily reports on mood, emotions, and interpersonal experiences using a smartphone before and after treatment

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Acute suicide risk requiring immediate intensive intervention, as assessed by the MINI.

Schizophrenia or other psychotic disorders

Bipolar I disorder

Severe substance use disorder, active within the past 6 months.

Trial design

Design model

Parallel

Treatments tested in this trial

Modular Intervention for Depression Therapy (MIND Therapy)
Behavioral
The MIND intervention is an algorithm-based, personalized, modular psychotherapy for adults with depression complicated by personality dysfunction and/or complex trauma. All participants receive a core evidence-based depression treatment that includes behavioral activation, cognitive, and interpersonal psychotherapy strategies. Additional short therapy modules are selected based on each participant's baseline emotional, interpersonal, and self-related functioning profile, using a predefined clinical algorithm. These modules target specific difficulties such as emotion regulation problems (DBT Module), sensitivity to rejection and interpersonal threat (MBT and CBASP Modules), social functioning difficulties (Social Thinning Module). The type and number of modules are tailored to individual needs following an algorithm based on baseline measures (DERS, A-RSQ, OQ-45-IR). Treatment is delivered as weekly individual psychotherapy sessions.
Psychotherapy as Usual (TAU)
Behavioral
Psychotherapy as usual (TAU) consists of individual psychotherapy delivered in public community mental health centers according to routine clinical practice. Treatment is provided weekly by trained clinicians and may vary in therapeutic orientation, techniques, and structure depending on the therapist and center. TAU is not guided by the modular psychotherapy protocol or algorithm used in the experimental intervention and reflects standard care available in the Chilean public mental health system.

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Modular Psychotherapy (MIND)Experimental treatment 1 intervention

Group B: Treatment as Usual (TAU)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Depression remission.

Primary depression outcomes will be assessed using the MINI International Neuropsychiatric Interview. The MINI is a structured interview. Remission is defined as a negative MINI assessment for major depressive disorder.

Time frame

Baseline (pre-intervention), end of treatment (session 15; approximately 3 months), and 3-month post-treatment (approximately 6 months after baseline assessment).

Clinically significant symptom reduction

Clinically significant symptom reduction will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 has a range between 0 and 27. Higher scores indicate more symptom severity. Clinically significant symptom reduction is defined as a reduction of at least 5 points on the PHQ-9 from baseline and a post-treatment PHQ-9 score ≤9.

Time frame

Baseline (pre-intervention), end of treatment (session 15; approximately 3 months), and 3-month post-treatment (approximately 6 months after baseline assessment).

Secondary outcomes

Emotional regulation difficulties

Emotional regulation will be assessed using the Difficulties in Emotion Regulation Scale (DERS-E). The DERS has a range of 25 to 125. Higher scores indicate more emotion regulation difficulties.

Time frame

Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).

Interpersonal sensitivity and rejection sensitivity

Interpersonal sensitivity will be assessed using the Adult Rejection Sensitivity Questionnaire (A-RSQ). Changes in sensitivity to interpersonal rejection will be evaluated from baseline to post-treatment. The A-RSQ has a range of 1 to 36. Higher scores indicate more rejection sensitivity.

Time frame

Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).

Interpersonal functioning and social problems

Interpersonal functioning will be measured using the Interpersonal Relations subscale of the Outcome Questionnaire - Interpersonal Relations (OQ-45-IR). Changes in social and interpersonal problems will be assessed from baseline to post-treatment. The range of the OQ-45 is 0 to 44. Higher scores indicate more interpersonal problems.

Time frame

Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).

Daily emotional and interpersonal functioning

Daily emotional and interpersonal functioning will be assessed using smartphone-based ecological momentary assessment (EMA). Participants will report momentary negative affect, interpersonal experiences, rejection sensitivity, and self-related experiences multiple times per day during one week before treatment and one week after treatment.

Time frame

One week prior to treatment initiation and one week following treatment completion (after 15 sessions; approximately 3 months after baseline assessment).

Other outcomes

Mentalizing Capacity

Patient's mentalizing capacity will be assess throughout the study using the Multidimensional Mentalizing Questionnaire (MMQ). The range of the MMQ is 1 to 5. Higher scores indicate higher mentalizing capacity.

Time frame

Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pontificia Universidad Catolica de Chile

Lead sponsor

MIDAP Millennium Institute for Research in Depression and Personality

Collaborator

Source ClinicalTrials.gov

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