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NCT05118594 | NOT YET RECRUITING | Major Depressive Disorder


Testing a Precision Psychotherapy System for Low-income Patients
Sponsor:

National Council of Scientific and Technical Research, Argentina

Information provided by (Responsible Party):

Juan Martin Gomez Penedo

Brief Summary:

The purpose of this study is to evaluate the feasibility of an evidence-based system to recommend core interventions, before the beginning of treatment, to psychotherapists treating low-income patients with depressive or anxiety disorders.

Condition or disease

Major Depressive Disorder

Dysthymic Disorder

Specific Phobia

Social Anxiety Disorder

Panic Disorder

Agoraphobia

Generalized Anxiety Disorder

Intervention/treatment

Pre-treatment psychotherapy recommendations

Phase

NA

Detailed Description:

After providing a written inform consent, potential patients will undergo a 2-weeks screening period to determine if they meet eligibility criteria. Baseline information (i.e., derived from semi-structured intake interviews and baseline clinical measures) from patients who meet eligibility criteria and consent to participate in the study, will be use to feed a machine learning algorithm, developed in a previous study, to perform individual predictions and determine which interventions (i.e., cognitive, behavioral, interpersonal, or patient-centered) will be recommended for the individual patient. This recommendation (i.e., about the most personally well-suited intervention for a given patient) will be provided to therapists before the beginning of treatment. Patients will be treated with 15 sessions of psychotherapy. The investigators will examine the extent to which therapists adhered to the recommended interventions as the primary outcome. The investigators will also examine patient symptomatic/functional improvement as a secondary outcome.

Study Type : INTERVENTIONAL
Estimated Enrollment : 111 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Open-trial to Prospectively Test the Feasibility of a Precision Psychotherapy System for Low-income Patients
Actual Study Start Date : 2026-02
Estimated Primary Completion Date : 2026-11
Estimated Study Completion Date : 2026-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Diagnoses of a depressive disorder (i.e., major depressive disorder or dysthymic disorder) or an anxiety disorder (i.e., specific phobia, social anxiety disorder, panic disorder, agoraphobia or generalized anxiety disorder) determined with the Mini-International Neuropsychiatric Interview (MINI)
  • * A score of at least two (mild) in any the five items from the depression and anxiety domains of the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult
  • * A total family income below the poverty index threshold, determined by a Licensed Social Worker
  • * Aged 18 to 65
  • * Fluency in Spanish language
  • * Capacity to consent
Exclusion Criteria
  • * Psychosis
  • * Mania
  • * Suicidal ideation with intent and/or plan
  • * Substance abuse disorders
  • * History of organic mental disease.

Testing a Precision Psychotherapy System for Low-income Patients

Location Details

NCT05118594


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