Clinical trial NCT06467474: Psychoeducational Group for Depression
Official title: Psychoeducation for Major Depressive Disorder: Development and Evaluation of Effectiveness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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 \&lt;7)

Primary outcomes:
measure: Knowledge level
timeFrame: Time: baseline, post 6 weeks and 12 months.
measure: Depressive levels
timeFrame: Baseline, post 6 weeks, 3, 6 and 12 months.
Secondary outcomes:
measure: Depressive Thoughts
timeFrame: Baseline, post 6 weeks, 3, 6 and 12 months
measure: Avoidance behaviors
timeFrame: Baseline, post 6 weeks, 3, 6 and 12 months.
measure: Functionality
timeFrame: Baseline, post 6 weeks, 3, 6 and 12 months.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Institute of Psychiatry - Faculty of Medicine from University of Sao Paulo
Study officials:
References: