Group Interpersonal Psychotherapy (IPT-G) by non-specialists for the improvement of depressive symptoms in community young adults in Brazil
| ISRCTN | ISRCTN15775084 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15775084 |
| ClinicalTrials.gov (NCT) | NCT06480019 |
| Protocol serial number | CAAE 73830223.7.0000.5327 |
| Sponsors | Hospital de Clínicas de Porto Alegre, National Council for Scientific and Technological Development, Coordination for the Improvement of Higher Education Personnel (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil: CAPES) |
| Funders | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Hospital de Clínicas de Porto Alegre Research Incentive Fund (FIPE), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES) |
- Submission date
- 12/11/2025
- Registration date
- 19/11/2025
- Last edited
- 19/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression is a common mental health condition that affects mood, relationships, daily functioning, and quality of life. Many young adults do not receive timely psychological support, especially in settings with limited mental-health resources. This study aims to evaluate whether Group Interpersonal Psychotherapy (IPT-G), a structured group-based talking therapy recommended by the World Health Organization, can reduce depressive symptoms and improve social support and quality of life. The intervention in this study is delivered by trained non-specialist facilitators, such as medical or psychology students, under supervision.
Who can participate?
Young adults aged 18–24 years who are experiencing depressive symptoms may be eligible to take part. Participants must be able to attend weekly sessions and complete research assessments.
What does the study involve?
Participants first complete an eligibility assessment. Those who qualify are randomly assigned to either:
- Intervention group: eight weekly sessions of Group Interpersonal Psychotherapy (about 90 minutes each), or
- Control group (wait-list): continue with usual care and receive IPT-G after the study period if the intervention will be effective.
All participants complete questionnaires at baseline, during the intervention, after the final group session, and at a 6-month follow-up. Before joining the study, participants receive a full Participant Information Sheet and sign a written informed consent form.
What are the possible benefits and risks of participating?
Participants in the IPT-G group may experience improvements in mood, social relationships and quality of life . The wait-list group will also have access to the therapy after the study ends if it proves effective. Risks are minimal and mainly relate to discussing personal or emotional topics, which may cause temporary discomfort. Support and referrals are available if needed. Participation is voluntary, and individuals may withdraw at any time.
Where is the study run from?
The study is run by the Hospital de Clínicas de Porto Alegre (HCPA) in partnership with the Universidade Federal do Rio Grande do Sul (UFRGS) .
When is the study starting and how long is it expected to run for?
The study began recruitment in March 2024. Follow-up assessments continue for approximately 6 months after the therapy. The study will complete in June 2026, with the overall project expected to run until end of 2028.
Who is funding the study?
1. Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Brazil.
2. Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES), Brazil.
3. Hospital de Clínicas de Porto Alegre Research Incentive Fund (FIPE), Brazil.
Who is the main contact?
Dr. Neusa Sica da Rocha, Hospital de Clínicas de Porto Alegre (HCPA) / Universidade Federal do Rio Grande do Sul (UFRGS), nrocha@hcpa.edu.br
Contact information
Public, Scientific, Principal investigator
Rua Ramiro Barcelos, 2350
Porto Alegre
90035-903
Brazil
 ORCID ID |
0000-0002-7260-3033 |
|---|---|
| Phone | +55 (51) 3359.8294 |
| nrocha@hcpa.edu.br |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Placebo | |
| Assignment | Sequential | |
| Purpose | Treatment | |
| Scientific title | IPT-based group intervention by non-specialist for improvement of depressive symptoms in community young adults in brazil | |
| Study objectives | To evaluate the improvement in depressive symptoms after eight sessions of IPT-G among young adults with depressive symptoms in a community setting, conducted by non-specialists in a randomized trial. | |
| Ethics approval(s) |
Approved 27/10/2023, Research Ethics Committee (CEP) of Hospital de Clínicas de Porto Alegre (Av. Protásio Alves, 211 - Portão 4 - 5º andar do Bloco C - sala 5068 - Rio Branco, Porto Alegre, 90410-000, Brazil; +55(51)33596246; cepsecretaria@hcpa.edu.br), ref: 2023-0283 | |
| Health condition(s) or problem(s) studied | Depression | |
| Intervention | The trial is designed as a pragmatic, controlled, randomized, and longitudinal study, comprising an intervention group (experimental) and a control group (waiting list). The intervention group will receive an IPT-G intervention delivered by non-specialists, following an 8-week protocol. The intervention will focus on interpersonal relationships within the IPT model and will be delivered by a medical student and a medical doctor trained in IPT. Intervention Group Participants allocated to the intervention arm receive IPT-G delivered by non-specialists (a medical student and a medical doctor). The intervention follows a structured manual and consists of weekly group sessions conducted over 8 weeks. Sessions take place in private therapy rooms at the Centro de Estudos Luis Guedes (CELG), a psychotherapy training centre affiliated with the Hospital de Clínicas de Porto Alegre (HCPA). Facilitators receive structured training prior to delivery and weekly supervision during the intervention. Treatment fidelity is monitored through audio-recorded sessions and standardized fidelity checklists. After completing the 8-week intervention, participants are invited to a 6-month follow-up meeting to discuss maintenance of therapeutic strategies. Control Group (Waitlist) Participants allocated to the control arm are placed on a waitlist and continue receiving any usual care available in the community. They complete the same assessments at all the same time points as the intervention group. If the intervention proves effective, all control participants are offered access to the IPT-G program after completing their final assessment. Randomization Participants are randomly allocated in a 1:1 ratio to the intervention or waitlist control group using a computer-generated sequence via the REDCap randomization module. Allocation is conducted by an independent researcher who is not involved in intervention delivery. Randomization occurs in blocks after every 20 participants complete baseline assessments, ensuring balanced allocation across the recruitment period. Given the nature of the intervention, participants are not blinded to group allocation. However, data collectors and data analysts remain blinded to minimize bias. Total Duration per Arm: Intervention: 8-week IPT-G + 6-month follow-up Control: Waitlist for equivalent period | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
Depression and anxiety symptoms (HADS) | |
| Key secondary outcome measure(s) |
1. Quality of life, measured using the WHOQOL-BREF at baseline, during treatment (sessions 1–8), and post-treatment (6 months) | |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | All, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 24 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Live, work, or study in the geographic area of Porto Alegre 2. Express a desire to voluntarily participate in the research and sign an informed consent form 3. Be aged 18 to 24 years 4. Be able to attend all 8 meetings 5. Score ≥5 on the Patient Health Questionnaire (PHQ-9), without indication of suicidal ideation as assessed by item 9 (≤ 1) of the scale |
| Key exclusion criteria | 1. Manic or hypomanic episode (current) 2. Psychotic syndrome (current or past) 3. Substance dependence or substance abuse (last 12 months, except tobacco/nicotine) 4. Moderate or high suicide risk, as operationalized by the MINI 5. Diagnosis of other types of depression, such as bipolar disorder |
| Date of first enrolment | 01/03/2024 |
| Date of final enrolment | 30/04/2026 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Porto Alegre
90035-903
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Individual participant data will not be shared publicly because of confidentiality requirements and the sensitive nature of mental-health information. Only de-identified, aggregated data will be included in publications. Researchers who wish to access de-identified datasets for secondary analyses may contact the principal investigator, nrocha@hcpa.edu.br (Neusa Rocha), and requests will be evaluated by the research team and ethics committee. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 19/11/2025 | No | No | ||
| Poster results | 19/11/2025 | No | No |
Additional files
- 48477_ParticipantTimeline.pdf
- Other files
- 48477_RecruitmentPoster.png
- Poster results
Editorial Notes
13/11/2025: Study's existence confirmed by the Research Ethics Committee (CEP) of Hospital de Clínicas de Porto Alegre, Brazil.
