Implementation of Internet-Based Psychotherapy for OCD in Primary Health Care in Two Cities in the State of São Paulo

N/ANot Yet RecruitingNCT06658756

University of Sao Paulo General Hospital140 enrolled

Overview

The aim of this study is to assess the implementation of Internet-based Cognitive Behavioral Therapy (I-CBT) treatment in a Brazilian sample. Researchers will compare 140 participants (70 with I-CBT and 70 in usual care to see if the treatment is feasible. Participants will undergo online treatment for OCD, lasting 10 to 14 weeks.

Obsessive-compulsive disorder (OCD) affects 2 to 3% of the adult population worldwide. The efficacy of pharmacological therapy with IRS and cognitive-behavioral therapy (CBT) is well recognized, but the clinical spectrum of OCD symptoms makes it difficult for patients to engage in sessions outside the home, decreasing treatment adherence. CBT is a psychological intervention increasingly delivered over the internet, with studies showing its efficacy in patients with OCD. The present study aims to verify the efficacy of implementing internet-based psychotherapy (I-CBT) in the context of a developing country, identifying the barriers and facilitators of this implementation. It will be a pragmatic, randomized-controlled, parallel, open-label, two-arm clinical trial. The implementation will be carried out in the cities of Indaiatuba and Jaguariúna, state of São Paulo, in all their Basic Health Units, in which 140 participants will be randomized between the I-CBT and usual treatment (UT) groups. Results will be assessed post-treatment and at 3- and 12-month follow-up. The hypothesis is that I-CBT is an effective and feasible treatment modality for OCD in a large Brazilian sample.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Obsessive-Compulsive Disorder

Interventions

internet-CBTBEHAVIORAL

10 modules on line of I-CBT for OCD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * primary diagnosis of OCD according to the DSM-5 (American Psychiatric Association, 2013); * internet access. Exclusion Criteria: * acute suicide risk, assessed by a positive response (1, 2 or 3) to item 9 of the PHQ-9 and considered serious (suicidal imminence) in the suicide risk assessment protocol (S-RAP); * psychotic symptoms; * dependence on alcohol or other known psychoactive substances; * recent bereavement; * significant cognitive impairment; * terminal illness for clinical reasons (based on their knowledge of the patient); * illiterate patients or those unable to read (for example, due to severe dyslexia or visual impairment); * patients without access to the internet or an electronic device to access the treatment platform.

Locations (3)

Basic Health System

Indaiatuba, São Paulo, Brazil

University of Sao Paulo General Hospital.

São Paulo, São Paulo, Brazil

University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Y-BOCS

Yale Brown Obsessive-Compulsive Scale. (range from 0 to 40). The lower the score on the scale, the lower the severity or the greater the reduction of symptoms.

Time frame: From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment

Secondary Outcomes

PHQ-9

Patient Health Questionnaire-9 (range 0 to 27). The lower the score on the scale, the lower the severity or the greater the reduction of symptoms

Time frame: From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment

GAD-7

Generalized Anxiety Disorder 7-item (range 0 to 21). The lower the score on the scale, the lower the severity or the greater the reduction of symptoms.

Time frame: From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment

Data from ClinicalTrials.gov

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