Psychoeducational Group for Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-12-01

Brief Summary

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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

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Detailed Description

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Conditions

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Major Depressive Disorder (MDD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Clinical Group

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

Group Type EXPERIMENTAL

PEG-D program

Intervention Type BEHAVIORAL

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.

TAU

Intervention Type DRUG

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.

Control Group

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

Group Type ACTIVE_COMPARATOR

TAU

Intervention Type DRUG

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.

Interventions

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PEG-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.

Intervention Type BEHAVIORAL

TAU

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No