Interactive Technological Intervention to Improve Mental Health Symptoms in Primary Health Care

NCT06692842 | Not Yet Recruiting DMC

• 1 other identifier: 80837624.7.0000.0068
• Study Type: interventional
• Target: 12,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Insomnia

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  3 months

Secondary Outcomes (3)

• Social Support Assessment:

  3 months and 6 months

• Quality of Life

  3 months and 6 months

• Daily Activity Level:

  3 months and 6 months

Study Arms (1)

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.

Device: CONEMO App

Interventions

CONEMO App DEVICE

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.

CONEMO

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: the individual will declare the gender with which they identify
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Basic Health System

Indaiatuba and Jaguariúna, São Paulo, Brazil

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Paulo Rossi Menezes, Ph.D.

CONTACT

5530617444; pmenezes@usp.br

Alice C. M. Xavier, Ph.D.

CONTACT

5592664409; alicexavier@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After study completion and publication of the results
• Access Criteria: Upon request from others researchers

Locations

BR (1)