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

NCT06817109 | Not Yet Recruiting DMC

• 1 other identifier: 81434224.9.0000.0068
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 2

Brief 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

Depression; Insomnia; Anxiety

Outcome Measures

Primary Outcomes (3)

• PHQ-9 - Patient Health Questionnaire-9

  Reduction of 50% or more in the PHQ-9 score

  3 month follow up

• ISI - Insomnia Severity Index

  Reduction of 8 points or more in the ISI score

  3 month follow up

• GAD-7 - Generalized Anxiety Disorder 7-item

  Reduction of 50% or more in the GAD-7

  3 month follow up

Study Arms (2)

iCBT

EXPERIMENTAL

For participants allocated to ICBT, in addition to the usual care performed in the primary unit, these individuals will also receive digital intervention through an online platform specifically developed for this purpose. Depression and anxiety intervention will consist of 10 specific modules for the treatment of each disorder to be performed within 10 weeks. Insomnia intervention will consist of 9 specific modules for the treatment of insomnia, to be performed within 8 weeks. These modules use concepts associated with cognitive behavioral therapy and third-generation behavioral therapy and were created through the transcultural and digital adaptation the therapeutic ingredients present in consumed treatment manuals in the literature. In all modules, a therapist will be designated to accompany each patient.

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

Treatment as usual

NO INTERVENTION

Patients allocated to this arm will continue to receive the usual treatment in their health units, which usually consists of psychotropic drugs and psychological support

Interventions

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

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

Also known as: CONEMO

iCBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Basic Health System

Indaiatuba, São Paulo, Brazil

Location

Basic Health System

Jaguariúna, São Paulo, 13.910.027, Brazil

Location

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Paulo Rossi Menezes, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulo Rossi Menezes, PhD

CONTACT

5530617444; pmenezes@usp.br

Study Design

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

Model Details: comparison between the intervention and the treatment as usual

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: February 10, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the studies are published.
• Access Criteria: Upon request from others researchers.

Locations

BR (2)