Clinical trial NCT06692842: Interactive Technological Intervention to Improve Mental Health Symptoms in Primary Health Care
Official title: Implementation Study of an Interactive Technological Intervention to Improve Mental Health Symptoms in Primary Health Care Users
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Insomnia
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2024-11-18
Enrollment: 12400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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 \&gt;= 10 on the PHQ-9 Scale for Depression; and/or \&gt;= 11 on the IGI Scale for Insomnia; and/or \&gt;= 10 on the GAD-7 Scale for Anxiety.
* Be able to read the app\&#39;s instructions via a tablet or smartphone screen.

Exclusion Criteria:

* Individuals considered severe on the Suicide Risk Assessment Protocol-SRAP (suicidal imminence)

Primary outcomes:
measure: Proportion of participants who have 'recovered' from depressive symptoms (PHQ-9 < 10)
timeFrame: 3 months
measure: Proportion of participants who have 'recovered' from anxiety (GAD-7< 10)
timeFrame: 3 months
measure: Proportion of participants who have 'recovered' from insomnia (IGI<8)
timeFrame: 3 months
Secondary outcomes:
measure: Social Support Assessment:
timeFrame: 3 months and 6 months
measure: Quality of Life
timeFrame: 3 months and 6 months
measure: Daily Activity Level:
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Indaiatuba and Jaguariúna
country: Brazil
facility: Basic Health System
state: São Paulo
Study officials:
References: