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Implementation of Internet-based Psychotherapy for Symptoms of Depression, Insomnia and Anxiety in Primary Care in the Cities of Indaiatuba and Jaguariuna

NCT06817109 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2025-02-10

No results posted yet for this study

Summary

The main objective of this study is to evaluate the effectiveness and success of implementing internet-based cognitive behavioral psychotherapy (iCBT) guided by a therapist for symptoms of depression, insomnia and anxiety in individuals who did not respond to an automated intervention in primary care in the cities of Indaiatuba and Jaguariúna. Method: This is a pragmatic, prospective, randomized, two-arm, parallel-group, controlled clinical trial, comparing a therapist-guided Internet-based cognitive behavioral therapy (iCBT) treatment associated with usual care versus usual care alone (UC) for symptoms of depression, insomnia and anxiety in adults who attend primary care in the cities of Indaiatuba and Jaguariúna and who did not respond to a first phase of treatment with automated iCBT (not guided by a therapist) focused on these groups of symptoms. The results will be accessed during treatment, in the immediate post-treatment (after two weeks of completing treatment) and at 3 and 6 month follow-up.

Conditions

Interventions

DEVICE

interactive technological intervention for improvement of mental health symptoms in Primary Care users Health

Intervention based on cognitive and behavioral techniques, such as psychoeducation on anxiety, depression and insomnia; muscle relaxation and breathing techniques; sleep hygiene techniques, behavioral activation and mindfulness techniques

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Paulo Rossi Menezes, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-11-30
Completion
2028-11-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06817109 on ClinicalTrials.gov