Interactive Technological Intervention to Improve Mental Health Symptoms in Primary Health Care (NCT06692842) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Interactive Technological Intervention to Improve Mental Health Symptoms in Primary Health Care
Brazil12,400 participantsStarted 2026-01-05
Plain-language summary
This study aims to implement and evaluate a technological intervention called CONEMO to treat depressive symptoms, anxiety, and insomnia in adults who use primary health care services. The effectiveness of this intervention has already been proven in previous research, specifically for depressive symptoms. Implementation will occur in 28 basic health units in the municipalities of Indiatuba and Jaguariúna in the interior of São Paulo.
All eligible residents of the cities will be invited to participate.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Look for consultation in basic health units due to Major Depressive Disorder, Insomnia and/or Generalized Anxiety Disorder, or who receive home visits for the same reason.
* Score \>= 10 on the PHQ-9 Scale for Depression; and/or \>= 11 on the IGI Scale for Insomnia; and/or \>= 10 on the GAD-7 Scale for Anxiety.
* Be able to read the app\'s instructions via a tablet or smartphone screen.
Exclusion Criteria:
* Individuals considered severe on the Suicide Risk Assessment Protocol-SRAP (suicidal imminence)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants who have 'recovered' from depressive symptoms (PHQ-9 < 10)
Timeframe: 3 months
2
Proportion of participants who have 'recovered' from anxiety (GAD-7< 10)
Timeframe: 3 months
3
Proportion of participants who have 'recovered' from insomnia (IGI<8)