Major Depressive Disorder (MDDPEG-DNCT06467474
Psychoeducational Group for Depression
A study testing PEG-D program and TAU in people with Major Depressive Disorder (MDD, run by Ricardo Alberto Moreno, M.D., Ph.D. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Major Depressive Disorder (MDD
- What is being tested?
- PEG-D program and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Institute of Psychiatry - Faculty of Medicine from University of Sao Paulo
São Paulo, 05403903
Institute of Psychiatry IPqFMUSP Moreno, RA, PhD, 55-112661-6648, grudaipq@hc.fm.usp.br
Adriana Carneiro AM Adriana Carneiro, DsC., psicoeducacaogruda@gmail.com
About this study
Official title: 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
- Conditions
- Major Depressive Disorder (MDD
- Being tested
- PEG-D program, TAU
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-D programBehavioural
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.
TAUDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Group | Experimental | Participants will receive treatment as usual (TAU) associated with the psychoeducational program. Receives: 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. Receives: Drug: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge level
Learning quiz: Comprising of open and closed questions questions, it was designed to evaluate participants' level of knowledge regarding depression
Measured: 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.
Measured: Baseline, post 6 weeks, 3, 6 and 12 months.
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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).
Measured: Baseline, post 6 weeks, 3, 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Mar 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ricardo Alberto Moreno, M.D., Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467474
- Sponsor's protocol ID
- 76212623.1.0000.0068
- Acronym
- PEG-D
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40779501
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducation for Major Depressive Disorder: Development and Evaluation of Effectiveness
- ClinicalTrials.gov ID
- NCT06467474
- Acronym / sponsor ID
- PEG-D / 76212623.1.0000.0068
- Conditions
- Major Depressive Disorder (MDD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Ricardo Alberto Moreno, M.D., Ph.D.University, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Group | Experimental | Behavioral: PEG-D program, Drug: TAUParticipants will receive treatment as usual (TAU) associated with the psychoeducational program. |
| Control Group | Active comparator | Drug: TAUThe usual treatment will consist of outpatient follow-up for a period of twelve months. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-D programPEG-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. | Behavioural | Clinical Group |
| TAUThe 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. | Drug | Clinical Group, Control Group |
Primary outcome
Knowledge level
Time frame: Time: baseline, post 6 weeks and 12 months.
Learning quiz: Comprising of open and closed questions questions, it was designed to evaluate participants' level of knowledge regarding depression
Depressive levels
Time frame: Baseline, post 6 weeks, 3, 6 and 12 months.
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.
3 secondary outcomes
Depressive Thoughts
Time frame: Baseline, post 6 weeks, 3, 6 and 12 months
Avoidance behaviors
Time frame: Baseline, post 6 weeks, 3, 6 and 12 months.
Functionality
Time frame: Baseline, post 6 weeks, 3, 6 and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Derived from this study: PubMed 40779501Carneiro 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG-D program and TAU in people with Major Depressive Disorder (MDD, run by Ricardo Alberto Moreno, M.D., Ph.D. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo A Moreno (55-2661-6648, ricardo.moreno@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge level (time frame: Time: baseline, post 6 weeks and 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06467474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.