Psychoeducational Group for Depression

NCT06467474 | Recruiting

• 1 other identifier: 76212623.1.0000.0068
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

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

Conditions

Major Depressive Disorder (MDD

Outcome Measures

Primary Outcomes (2)

• Knowledge level

  Learning quiz: Comprising of open and closed questions questions, it was designed to evaluate participants' level of knowledge regarding depression

  Time: baseline, post 6 weeks and 12 months.

• Depressive levels

  Beck Depression Inventory-BDI-II. It consists of 21 items and measures the intensity of depression in the last 14 days. The instrument has 21 items, and the higher the score, the greater the intensity of depression.

  Baseline, post 6 weeks, 3, 6 and 12 months.

Secondary Outcomes (3)

• Depressive Thoughts

  Baseline, post 6 weeks, 3, 6 and 12 months

• Avoidance behaviors

  Baseline, post 6 weeks, 3, 6 and 12 months.

• Functionality

  Baseline, post 6 weeks, 3, 6 and 12 months.

Study Arms (2)

Clinical Group

EXPERIMENTAL

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

Behavioral: PEG-D program; Drug: TAU

Control Group

ACTIVE COMPARATOR

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

Drug: TAU

Interventions

PEG-D program 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.

Clinical Group

TAU 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.

Clinical Group; Control Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ricardo Alberto Moreno, M.D., Ph.D.: lead

Study Sites (1)

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

São Paulo, 05403903, Brazil

RECRUITING

Related Publications (1)

• Carneiro AM, Silva SLT, Fernandes FDS, Barretto JR, de Brito TR, Moreno LH, Pimentel FC, Jorge BA, Dos Santos LA, Fernandes Ramos MR, Moreno RA. Psychoeducation Group for Depression (PEG-D): Study protocol for a prospective, randomized, single-blind, crossover trial. PLoS One. 2025 Aug 8;20(8):e0329006. doi: 10.1371/journal.pone.0329006. eCollection 2025.

  PMID: 40779501 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Ricardo A Moreno

CONTACT

55-2661-6648; ricardo.moreno@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 21, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

BR (1)