DepressionNCT06692842
Interactive Technological Intervention to Improve Mental Health Symptoms in Primary Health Care
A study testing CONEMO App in people with Depression and Anxiety, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Insomnia
- What is being tested?
- CONEMO App
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,400 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jan 2026to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals considered severe on the Suicide Risk Assessment Protocol-SRAP (suicidal imminence)
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
Basic Health System
Indaiatuba and Jaguariúna, São Paulo
Paulo Rossi Menezes, PhD, (11) 2661-7585, pmenezes@usp.br
Alice Xavier, PhD, +55 51 99266 4409, alicexavier@gmail.com
About this study
Official title: Implementation Study of an Interactive Technological Intervention to Improve Mental Health Symptoms in Primary Health Care Users
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.
Read the detailed description
A type III hybrid implementation and effectiveness study, with a mixed-method explanatory sequential design consisting of two distinct stages: the first quantitative, followed by qualitative. The method is indicated when the researcher wishes to use qualitative data to help interpret and explain the initial quantitative findings and deepen them. The elements of both methods are analyzed separately and then merged, looking for convergences, divergences, contradictions, or relationships between the two databases.
The qualitative data will help to interpret, explain and deepen the quantitative findings. The guidelines of the Consolidated Criteria for Reporting Qualitative Research (COREQ) will be followed, a 32-item instrument that guides the conduct of the interview and analysis of qualitative data, also validated in Portuguese in Brazil.
Study site The study will be carried out in 28 Basic Health Units (UBS) in two municipalities in the interior of São Paulo, Indaiatuba and Jaguariúna, located approximately 100 km from the capital São Paulo, in the state of São Paulo, Brazil.
Study population - stakeholder groups Patients/service users - user category Our study population will be made up of adult individuals (18 years or older) who live in the municipality of Indaiatuba or Jaguariúna and attend the UBS and who show significant symptoms of depression, anxiety or insomnia.
Health professionals, service managers and local managers - professional categories Adults (18 years or older) from the groups of interest will also participate in the study: health professionals from the UBS in the municipalities of Jaguariúna and Indaiatuba, service managers, health department managers, or primary care and mental health coordinators. We consider these individuals to be the main stakeholders, in addition to the users and main participants in the research, in the unfolding of the CONEMO intervention implementation study.
Study population
User participants - quantitative study:
All individuals screened at the cities' UBSs with positive symptoms for insomnia, anxiety or depression.
Participants - users, health professionals and managers - barriers and facilitators - qualitative study The focus groups in this study will be divided into categories of participants selected from each UBS involved. The categories of participation will be users, technical health professionals, senior health professionals and the manager of each participating unit. Simple randomization will be carried out to select one participant from each category among users and health professionals. With regard to managers, the invitation will be extended to all managers of the participating health units. These focus groups will be conducted separately for each category of participants at the end of three months from the start of the study. It is important to note that the users included in the focus groups may be at different stages of using the application. Specific guiding scripts will be used to collect the qualitative data, which will be drawn up after analyzing the quantitative data.
Research Steering Committee - CGP This committee plays a crucial role in monitoring and evaluating the outcomes of the implementation of interventions and policies. Composed of a multidisciplinary team, including academic researchers, local managers, and service workers, the committee facilitates the active participation of all stakeholders in the research process. Its main objective is to ensure that contextual elements are taken into account and that real conditions are understood and worked on. The committee meets regularly to discuss the research progress, evaluate the strategies' implementation and provide constructive feedback. This participatory and collaborative approach helps to identify and overcome possible challenges in implementation, thus promoting the effectiveness and sustainability of the mental health policies implemented. The CGP will also include users of municipal health services.
- Conditions
- Depression, Anxiety, Insomnia
- Being tested
- CONEMO App
- Medical subject headings
- Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONEMO AppDevice
The CONEMO application has three protocol, aimed to improived symptoms of depression, insomnia and anxiety. It is based on cognitive behavioral therapy (CBT) and contextual behavioral therapy (activation behavioral theraphy, mindfulness) and adapted considering broader contexts of mental health care, which involves a low-intensity intervention administered without any or minimal professional guidance and widely accessible. In a brief and structured format, CONEMO involves offering the intervention through texts, audios and videos. Based on the principles of CBT and contextual thrapies, CONEMO is organized into structured sessions that promote psychoeducation and teach basic behavioral skills, often through interactive exercises. Each journey was developed based on scientific evidences. The CONEMO journeys comprise seven weekly modules.
| Study group | Role | What they receive |
|---|---|---|
| CONEMO | Experimental | CONEMO is a low-intensity psychoeducational program which is made available to users via smartphones compatible with Android or iOS systems. At the same time, the designed healthcare professional use a tablet to monitor user adherence to the intervention. CONEMO comprise seven weekly modules, totally self-guides. Receives: Device: CONEMO App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who have 'recovered' from depressive symptoms (PHQ-9 < 10)
Patient Health Questionnaire-9 (PHQ-9) is a questionnaire to access the severity of participants' depressive symptoms. The PHQ-9 score varies according to the severity of the symptoms and is classified as follows: no depression (0 to 4), mild symptoms (5 to 9), moderate symptoms (10 to 14), moderately severe symptoms (15 to 19) and severe symptoms (20 to 27). A cut-off point of 10 is suggested to indicate the presence of significant depressive symptoms.
Measured: 3 months
Proportion of participants who have 'recovered' from anxiety (GAD-7< 10)
General Anxiety Disorder-7 (GAD-7) scale, which measures common symptoms associated with generalized anxiety disorder in the last two weeks. Each of the scale's seven items ranges from 0 ('not at all') to 3 ('almost every day'), resulting in a total score ranging from 0 to 21. A suggested cut-off point of more than 10 points indicates the presence of anxiety.
Measured: 3 months
Proportion of participants who have 'recovered' from insomnia (IGI<8)
Insomnia Severity Index (IGI) is a retrospective instrument that assesses the last month and is made up of seven items that explore various aspects of sleep, including difficulties initiating or maintaining sleep, early morning awakening, satisfaction with sleep, daytime impairment, perception of sleep problems by other people, and concern about sleep problems.
Respondents use a Likert scale ranging from 0 (no severity) to 4 (high severity), resulting in a total score ranging from 0 to 28. This score is classified as follows: no insomnia (0 to 7), mild insomnia (8 to 14), moderate insomnia (15 to 21) and severe insomnia (22 to 28
Measured: 3 months
Secondary outcomes (3)
Social Support Assessment:
The participant's relationships with other people, i.e. whether they have a support network, will be explored throught a questionnaire
Measured: 3 months and 6 months
Quality of Life
The level 3 version of the 5-item EUROQol questionnaire (EQ 5D-3L), which covers five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with three levels of severity, will be used to access changes in quality of life.
Measured: 3 months and 6 months
Daily Activity Level:
Through the short form of the Behavioral Activation Scale for Depression (BADS). The BADS is a 9-item scale that measures the frequency of activation and avoidance behaviors that are hypothetically fundamental to the mechanisms of depression. This instrument will only be applied to participants in the depression journey.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start5 Jan 2026 (estimated)
- 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.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Individuals with anxiety, depression or insomnia will receive the CONEMO intervention, consisting of 7 self-applied modules of strategies based on cognitive-behavioral therapy techniques. The intervention will be comparet to the treatment as usual.
- Masking
- None (open label)
- Enrolment
- 12,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692842
- Sponsor's protocol ID
- 80837624.7.0000.0068
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared on the OSF platform after the study is completed, upon request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Study of an Interactive Technological Intervention to Improve Mental Health Symptoms in Primary Health Care Users
- ClinicalTrials.gov ID
- NCT06692842
- Acronym / sponsor ID
- 80837624.7.0000.0068
- Conditions
- Depression, Anxiety, Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12,400 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Nov 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.
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.
Detailed description
A type III hybrid implementation and effectiveness study, with a mixed-method explanatory sequential design consisting of two distinct stages: the first quantitative, followed by qualitative. The method is indicated when the researcher wishes to use qualitative data to help interpret and explain the initial quantitative findings and deepen them. The elements of both methods are analyzed separately and then merged, looking for convergences, divergences, contradictions, or relationships between the two databases.
The qualitative data will help to interpret, explain and deepen the quantitative findings. The guidelines of the Consolidated Criteria for Reporting Qualitative Research (COREQ) will be followed, a 32-item instrument that guides the conduct of the interview and analysis of qualitative data, also validated in Portuguese in Brazil.
Study site The study will be carried out in 28 Basic Health Units (UBS) in two municipalities in the interior of São Paulo, Indaiatuba and Jaguariúna, located approximately 100 km from the capital São Paulo, in the state of São Paulo, Brazil.
Study population - stakeholder groups Patients/service users - user category Our study population will be made up of adult individuals (18 years or older) who live in the municipality of Indaiatuba or Jaguariúna and attend the UBS and who show significant symptoms of depression, anxiety or insomnia.
Health professionals, service managers and local managers - professional categories Adults (18 years or older) from the groups of interest will also participate in the study: health professionals from the UBS in the municipalities of Jaguariúna and Indaiatuba, service managers, health department managers, or primary care and mental health coordinators. We consider these individuals to be the main stakeholders, in addition to the users and main participants in the research, in the unfolding of the CONEMO intervention implementation study.
Study population
User participants - quantitative study:
All individuals screened at the cities' UBSs with positive symptoms for insomnia, anxiety or depression.
Participants - users, health professionals and managers - barriers and facilitators - qualitative study The focus groups in this study will be divided into categories of participants selected from each UBS involved. The categories of participation will be users, technical health professionals, senior health professionals and the manager of each participating unit. Simple randomization will be carried out to select one participant from each category among users and health professionals. With regard to managers, the invitation will be extended to all managers of the participating health units. These focus groups will be conducted separately for each category of participants at the end of three months from the start of the study. It is important to note that the users included in the focus groups may be at different stages of using the application. Specific guiding scripts will be used to collect the qualitative data, which will be drawn up after analyzing the quantitative data.
Research Steering Committee - CGP This committee plays a crucial role in monitoring and evaluating the outcomes of the implementation of interventions and policies. Composed of a multidisciplinary team, including academic researchers, local managers, and service workers, the committee facilitates the active participation of all stakeholders in the research process. Its main objective is to ensure that contextual elements are taken into account and that real conditions are understood and worked on. The committee meets regularly to discuss the research progress, evaluate the strategies' implementation and provide constructive feedback. This participatory and collaborative approach helps to identify and overcome possible challenges in implementation, thus promoting the effectiveness and sustainability of the mental health policies implemented. The CGP will also include users of municipal health services.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Individuals with anxiety, depression or insomnia will receive the CONEMO intervention, consisting of 7 self-applied modules of strategies based on cognitive-behavioral therapy techniques. The intervention will be comparet to the treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| CONEMO | Experimental | Device: CONEMO AppCONEMO is a low-intensity psychoeducational program which is made available to users via smartphones compatible with Android or iOS systems. At the same time, the designed healthcare professional use a tablet to monitor user adherence to the intervention. CONEMO comprise seven weekly modules, totally self-guides. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals considered severe on the Suicide Risk Assessment Protocol-SRAP (suicidal imminence)
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 |
|---|---|---|
| CONEMO AppThe CONEMO application has three protocol, aimed to improived symptoms of depression, insomnia and anxiety. It is based on cognitive behavioral therapy (CBT) and contextual behavioral therapy (activation behavioral theraphy, mindfulness) and adapted considering broader contexts of mental health care, which involves a low-intensity intervention administered without any or minimal professional guidance and widely accessible. In a brief and structured format, CONEMO involves offering the intervention through texts, audios and videos. Based on the principles of CBT and contextual thrapies, CONEMO is organized into structured sessions that promote psychoeducation and teach basic behavioral skills, often through interactive exercises. Each journey was developed based on scientific evidences. The CONEMO journeys comprise seven weekly modules. | Device | CONEMO |
Primary outcome
Proportion of participants who have 'recovered' from depressive symptoms (PHQ-9 < 10)
Time frame: 3 months
Patient Health Questionnaire-9 (PHQ-9) is a questionnaire to access the severity of participants' depressive symptoms. The PHQ-9 score varies according to the severity of the symptoms and is classified as follows: no depression (0 to 4), mild symptoms (5 to 9), moderate symptoms (10 to 14), moderately severe symptoms (15 to 19) and severe symptoms (20 to 27). A cut-off point of 10 is suggested to indicate the presence of significant depressive symptoms.
Proportion of participants who have 'recovered' from anxiety (GAD-7< 10)
Time frame: 3 months
General Anxiety Disorder-7 (GAD-7) scale, which measures common symptoms associated with generalized anxiety disorder in the last two weeks. Each of the scale's seven items ranges from 0 ('not at all') to 3 ('almost every day'), resulting in a total score ranging from 0 to 21. A suggested cut-off point of more than 10 points indicates the presence of anxiety.
Proportion of participants who have 'recovered' from insomnia (IGI<8)
Time frame: 3 months
Insomnia Severity Index (IGI) is a retrospective instrument that assesses the last month and is made up of seven items that explore various aspects of sleep, including difficulties initiating or maintaining sleep, early morning awakening, satisfaction with sleep, daytime impairment, perception of sleep problems by other people, and concern about sleep problems. Respondents use a Likert scale ranging from 0 (no severity) to 4 (high severity), resulting in a total score ranging from 0 to 28. This score is classified as follows: no insomnia (0 to 7), mild insomnia (8 to 14), moderate insomnia (15 to 21) and severe insomnia (22 to 28
3 secondary outcomes
Social Support Assessment:
Time frame: 3 months and 6 months
Quality of Life
Time frame: 3 months and 6 months
Daily Activity Level:
Time frame: 3 months and 6 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 7 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be shared on the OSF platform after the study is completed, upon request.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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 CONEMO App in people with Depression and Anxiety, run by University of Sao Paulo General Hospital 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 1 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: opening soon, as of the sponsor's last update on 7 Jan 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 Paulo Rossi Menezes, Ph.D. (5530617444, pmenezes@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who have 'recovered' from depressive symptoms (PHQ-9 < 10) (time frame: 3 months). The study lists 3 primary outcomes in all. 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 7 Jan 2026.