Implementation of Internet-based Psychotherapy for Symptoms of Depression, Insomnia and Anxiety in Primary Care in the Cities of Indaiatuba and Jaguariuna
Key facts
- Where
- Indaiatuba and Jaguariúna, BrazilSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06817109, who can take part
Where in Brazil
- Basic Health SystemIndaiatuba, BrazilContact: Paulo Rossi Menezes, OhDNo longer taking part
- Basic Health SystemJaguariúna, BrazilContact: Paulo Rossi Menezes, Ph.D.No longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Sao Paulo General Hospital
- Trial code
- NCT06817109
- Record updated
- 10 February 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Participants included in the first phase of the study; Depression complaints with significant scores for depression> = 10 points; and/or; Insomnia complaints with significant score for insomnia> = 11; and/or; Complaints of significant score for anxiety> = 10; participants with significant symptoms in more than one domain, together with the professional, will be invited to elect a main focus of treatment, or by be the main problem and/or the one the patient is most motivated to treat.
Exclusion: Individuals who have acute suicide risk, evaluated by positive response (1, 2 or 3) to PHQ-9 item 9 and considered severe (suicidal illusion) in the Suicide Risk Assessment Protocol (S-RAP) will be excluded; Individuals identified as bass in S-rap will be sent for emergency care according to security monitoring protocol presented in the topic "Evaluation and Risk Monitoring" of this project.