Psychoeducational Group for Depression (PEG-D)

Ricardo Alberto Moreno, M.D., Ph.D.

Status: Enrolling

Conditions: Major Depressive Disorder (MDD

Treatments: Drug: TAU; Behavioral: PEG-D program

Study type: Interventional

Funder types: Other

Identifiers

NCT06467474

76212623.1.0000.0068

Details and patient eligibility

About

The study aims to investigate the efficacy of a psychoeducational program as an adjunctive treatment for depression. The study will involve 338 patients diagnosed with Major Depressive Disorder (MDD) of moderate severity. Participants will be randomly assigned to receive either Treatment as usual (TAU) alone or TAU plus the psychoeducational program. The program consists of six weekly group sessions covering information and techniques for coping with depression. Primary outcomes include a reduction in depressive symptoms measured by the Beck Depression Inventory-II (BDI-II) and increased knowledge of depression. Secondary outcomes include improvements in functionality and quality of life. The study aims to provide insights into the effectiveness of psychoeducation in improving outcomes for individuals with depression

Enrollment: 338 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Both sexes;
• Ages between 18 and 65 years old;
• Diagnosis of Major Depressive Disorder (MDD) made by a clinician according to Diagnostic Statistical Manual criteria-5-Text Revised (DSM-5-TR)
• Patients with Hamilton Depressive Rating Scale-17 items (HDRS-17) scores 14-23;
• Informed and signed consent form.

Exclusion:

• Unstable serious clinical or neurological diseases;
• Postpartum depression or other types of depressive disorders (disruptive mood dysregulation disorder, pre-menstrual, substance/medication-induced depressive disorder, depressive disorder due to another medical condition, another disorder specified depressive disorder and unspecified depressive disorder);
• Other psychiatric disorders;
• Patients with active psychotic symptoms;
• Suicidality risks
• Patients already undergoing any other psychological treatment for MDD;

Discontinuation:

• More than two absences during treatment;
• Those who miss more than two sessions/consultations, whether medical treatment or the psychoeducational program;
• Non-response to the use of Sertraline over the initial eight weeks; Presence of hypomanic symptoms at any time during treatment (Young <7)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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338 participants in 2 patient groups

Clinical Group

Experimental group

Description:

Participants will receive treatment as usual (TAU) associated with the psychoeducational program.

Treatment:

Drug: TAU

Behavioral: PEG-D program

Control Group

Active Comparator group

Description:

The usual treatment will consist of outpatient follow-up for a period of twelve months.

Treatment:

Drug: TAU