Psychoeducational Group for Depression (PEG-D)

Psychoeducation for Major Depressive Disorder: Development and Evaluation of Effectiveness

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

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder (MDD
• Intervention / Treatment: Behavioral: PEG-D program; Drug: TAU

• Study Type: Interventional
• Enrollment (Estimated): 338
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ricardo A Moreno; Phone Number: 55-2661-6648; Email: ricardo.moreno@hc.fm.usp.br

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403903
    • Recruiting
    • Institute of Psychiatry - Faculty of Medicine from University of Sao Paulo
    • Contact: Institute of Psychiatry IPqFMUSP Moreno, RA, PhD; Phone Number: 55-112661-6648; Email: grudaipq@hc.fm.usp.br
    • Contact: Adriana Carneiro AM Adriana Carneiro, DsC.; Email: psicoeducacaogruda@gmail.com
    • Principal Investigator: Adriana M. Carneiro, DsC
    • Sub-Investigator: Sara L. T. Silva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinical Group; Participants will receive treatment as usual (TAU) associated with the psychoeducational program.	Behavioral: 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.; Drug: 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.
Active Comparator: Control Group; The usual treatment will consist of outpatient follow-up for a period of twelve months.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Thoughts	Depressive Thoughts Scale (EPD): The instrument has 26 items, divided into two factors, the first being low self-esteem/hopelessness, with 16 items referring to the subject's negative perception of themselves and their future perspectives and the second on functionality in relationships, with 10 items on the positive evaluation that the subject presents about their relationship with others and how they evaluate the support they receive.	Baseline, post 6 weeks, 3, 6 and 12 months
Avoidance behaviors	Cognitive Behavioral Avoidance Scale (CBAS): The instrument assesses typical avoidance styles of depressed people and has 31 items, divided into four factors, namely: Behavioral/Social (8 items), Non-Social Behavioral (6 items), Social Cognitive (7 items) and Non-Social Cognitive ( 10 items).	Baseline, post 6 weeks, 3, 6 and 12 months.
Functionality	Global Functioning Ranting Scale (GAF): The GAF is a functioning assessment scale that ranges from 0 to 100, with higher scores indicative of higher levels of functioning. The Clinical Global Impression Scale (CGI) will also be used, a general summary measure determined by the physician that takes into account all available information, including knowledge of the patient's history and the impact of symptoms on the patient's functional capacity, with measures ranging from 1 (much better) to 7 (much worse).	Baseline, post 6 weeks, 3, 6 and 12 months.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 76212623.1.0000.0068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No