RecruitingNot ApplicableNCT06467474

Psychoeducational Group for Depression

Psychoeducation for Major Depressive Disorder: Development and Evaluation of Effectiveness

Sponsor

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

Enrollment

338 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder (MDD)

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

Min Age: 18 YearsMax Age: 59 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a group-based psychoeducational program for people with moderate major depressive disorder — teaching participants about depression, coping skills, and self-management strategies in a structured group setting. **You may be eligible if...** - You are between 18 and 65 years old (male or female) - You have a clinical diagnosis of major depressive disorder (MDD) based on DSM-5 criteria - Your depression severity score (HDRS-17) falls in the moderate range (14–23) **You may NOT be eligible if...** - You have an unstable serious medical or neurological condition - You have postpartum depression or another subtype of depressive disorder - You have bipolar disorder or another coexisting serious psychiatric condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPEG-D program

PEG-D will be carried out in person, open format, for six consecutive weeks lasting 90 minutes each. An approximate group of 6 to 10 participants will be led by a team of experienced psychologists and psychiatrists. Each group will have a main therapist and a co-therapist to ensure effective support and guidance for participants. Before the start of the group, participants received a booklet containing the content of the sessions.

DRUGTAU

The treatment will start with Sertraline (SSRI) - doses of 50 mg and adjusting as necessary according to the patient\'s profile. After 8 weeks, if the patient experiences remission, they will continue on monotherapy with Sertraline. In case of relapse Bupropion, Quetiapine, Lithium or Aripiprazole might be add-on. In this case, add-on medications will be determined according to the patient profile, by the clinician. If there is a response above 25% of the symptoms, but without remission, the patient will proceed to augmentation with the aforementioned medications and if there is no improvement of at least 25%, the patient will be considered drop-out. Associations with Lorazepam if necessary will be allowed in any phase of the study.

Locations(1)

Institute of Psychiatry - Faculty of Medicine from University of Sao Paulo

São Paulo, Brazil

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