DepressionNCT06480019
IPT-based Group Intervention by Non-specialist for Improvement of Depressive Symptoms in Community Young Adults in Brazil
A study testing Interpersonal psychotherapy in people with Depression and Interpersonal Relations, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Major depressive disorder is a highly prevalent, recurrent, and debilitating disease, the third cause of years of lost life in the world, and it may be the most common disease in 2030, according to the World Health Organization (WHO). Furthermore, it's also related to decreased quality of life and high mortality. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Depression, Interpersonal Relations
- What is being tested?
- Interpersonal psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2024to 31 Dec 2028
- 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 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Young adults (between 18 and 24 years old)
- Young adults who work, live or study in Porto Alegre
- PHQ ≥ 5 - without suicide ideation
Who cannot join
- Maniac or hypomanic episode
- Psychotic Syndrome
- Substance Abuse
- Suicide Risk or Ideation
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
Clinical Hospital for Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Neusa Sica da Rocha, PhD, (5551) 3359-8000, nrocha@hcpa.edu.br
About this study
Official title: IPT-based Group Intervention by Non-specialist for Improvement of Depressive Symptoms in Community Young Adults in Brazil: a Randomized Clinical Trial
Major depressive disorder is a highly prevalent, recurrent, and debilitating disease, the third cause of years of lost life in the world, and it may be the most common disease in 2030, according to the World Health Organization (WHO). Furthermore, it's also related to decreased quality of life and high mortality. Interpersonal psychotherapy (IPT) is a first-line treatment and can also be used for the prevention of depression.
This randomized controlled clinical trial is planned to have 50 participants randomized between an interventional and a control group (waiting list). Our study covers young adults (18 to 24 years old) with depression. Participants will be invited by social media to undergo treatment in an IPT group. The intervention group will be separated into groups with up to 10 participants, with a weekly meeting for eight weeks. The intervention will focus on interpersonal relationships within the model of IPT and will be held by a university student and a doctor trained in IPT.
- Conditions
- Depression, Interpersonal Relations
- Being tested
- Interpersonal psychotherapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal psychotherapyBehavioural
Interpersonal psychotherapy is a first-line treatment and can also be used for the prevention of depression.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Participants that receive psychotherapy Receives: Behavioral: Interpersonal psychotherapy |
| Waiting list | No intervention | Participants that are waiting for intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale consists of 14 items, of which 7 assess anxiety and 7 assess depression. Each item is scored from 0 to 3, and each subscale has a maximum score of 21 points with higher scores indicating greater symptom severity.
Measured: Pre-treatment, Week 1 to 8
Secondary outcomes (5)
Patient Health Questionnaire-9
The PHQ-9 is a self-administered instrument that quantitatively assesses the severity of depressive symptoms over the past two weeks. It consists of nine items corresponding to the diagnostic criteria for major depressive disorder in the DSM-IV. Each item is scored on a 4-point Likert scale (0 = not at all to 3 = nearly every day), resulting in a score ranging from 0 to 27.
Measured: Pre-treatment, Week 1 to 8
Social support scale (MOS-SSS)
The Medical Outcomes Study Social Support Survey (MOS-SSS) measures each individual's perceptions of personal support. The scale comprises five support factors (emotional, informational, material, affective, and positive social interaction). Higher scores indicate greater perceived support.
Measured: Pre-treatment, Week 1 to 8
Quality of Life (WHOQOL-BREF)
The WHOQOL-BREF is a scale with 26 items that measure quality of life. It includes two general items and 24 items representing four domains (physical, psychological, social relationships, and environmental).
Measured: Pre-treatment, Week 1 to 8
Clinical Global Impression (CGI)
The Clinical Global Impressions (CGI) scale is an instrument that enables clinicians to assess the overall severity of the illness, the change in clinical status over time, and the effectiveness of the intervention used. Its score can range from 1 (not ill) to 7 (extremely ill).
Measured: Pre-treatment, Week 1 to 8
Beck Depression Inventory (BDI)
It's a self-report instrument and assesses the presence and severity of depressive symptoms. It consists of 21 items describing cognitive, affective, and somatic manifestations of depression. Each item is scored in a Likert scale ranging from 0 to 3, varying from 0 to 63 points
Measured: Pre-treatment; Week 1-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neusa Sica da Rocha, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480019
- Sponsor's protocol ID
- 2023-0283
- Status last verified
- Oct 2025
- First submitted
- 24 Jun 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IPT-based Group Intervention by Non-specialist for Improvement of Depressive Symptoms in Community Young Adults in Brazil: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06480019
- Acronym / sponsor ID
- 2023-0283
- Conditions
- Depression, Interpersonal Relations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 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.
Major depressive disorder is a highly prevalent, recurrent, and debilitating disease, the third cause of years of lost life in the world, and it may be the most common disease in 2030, according to the World Health Organization (WHO). Furthermore, it's also related to decreased quality of life and high mortality. Interpersonal psychotherapy (IPT) is a first-line treatment and can also be used for the prevention of depression.
This randomized controlled clinical trial is planned to have 50 participants randomized between an interventional and a control group (waiting list). Our study covers young adults (18 to 24 years old) with depression. Participants will be invited by social media to undergo treatment in an IPT group. The intervention group will be separated into groups with up to 10 participants, with a weekly meeting for eight weeks. The intervention will focus on interpersonal relationships within the model of IPT and will be held by a university student and a doctor trained in IPT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Interpersonal psychotherapyParticipants that receive psychotherapy |
| Waiting list | No intervention | –Participants that are waiting for intervention |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Young adults (between 18 and 24 years old)
- Young adults who work, live or study in Porto Alegre
- PHQ ≥ 5 - without suicide ideation
Key exclusion criteria (4 listed)
- Maniac or hypomanic episode
- Psychotic Syndrome
- Substance Abuse
- Suicide Risk or Ideation
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 |
|---|---|---|
| Interpersonal psychotherapyInterpersonal psychotherapy is a first-line treatment and can also be used for the prevention of depression. | Behavioural | Intervention |
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: Pre-treatment, Week 1 to 8
The Hospital Anxiety and Depression Scale consists of 14 items, of which 7 assess anxiety and 7 assess depression. Each item is scored from 0 to 3, and each subscale has a maximum score of 21 points with higher scores indicating greater symptom severity.
5 secondary outcomes
Patient Health Questionnaire-9
Time frame: Pre-treatment, Week 1 to 8
Social support scale (MOS-SSS)
Time frame: Pre-treatment, Week 1 to 8
Quality of Life (WHOQOL-BREF)
Time frame: Pre-treatment, Week 1 to 8
Clinical Global Impression (CGI)
Time frame: Pre-treatment, Week 1 to 8
Beck Depression Inventory (BDI)
Time frame: Pre-treatment; Week 1-8
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 13 Apr 2026.
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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 Interpersonal psychotherapy in people with Depression and Interpersonal Relations, run by Hospital de Clinicas de Porto Alegre 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 3 inclusion and 4 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 13 Apr 2026. 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 Neusa Sica da Rocha, PhD (55(51) 3359-8000, nrocha@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) (time frame: Pre-treatment, Week 1 to 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.