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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• PHQ-9 - Patient Health Questionnaire-9 — 3 month follow up
  Reduction of 50% or more in the PHQ-9 score
• ISI - Insomnia Severity Index — 3 month follow up
  Reduction of 8 points or more in the ISI score
• GAD-7 - Generalized Anxiety Disorder 7-item — 3 month follow up
  Reduction of 50% or more in the GAD-7

Trial sites (2)

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