Testing a Precision Psychotherapy System for Low-income Patients (ML_LMIC)

National Scientific and Technological Research Council (CONICET)

Status: Not yet enrolling

Conditions: Major Depressive Disorder; Panic Disorder; Specific Phobia; Generalized Anxiety Disorder; Dysthymic Disorder; Agoraphobia; Social Anxiety Disorder

Treatments: Behavioral: Pre-treatment psychotherapy recommendations

Study type: Interventional

Funder types: Other

Identifiers

NCT05118594

ML_LMIC_2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

Pre-treatment recommendations

Experimental group

Description:

Therapists receive automatized feedback at the beginning of the treatments with recommendations regarding the most appropriate interventions to use with their patients based on a machine learning algorithm developed on a previous study.

Treatment:

Behavioral: Pre-treatment psychotherapy recommendations