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

NCT ID: NCT06658756

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2028-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I-CBT

Internet cognitive-behavioral therapy

Group Type: EXPERIMENTAL

internet-CBT

Intervention Type: BEHAVIORAL

10 modules on line of I-CBT for OCD

TU

Treatment as Usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

internet-CBT

10 modules on line of I-CBT for OCD

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Brazil

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Other Identifiers

74835123.7.0000.0068

Identifier Type: -

Identifier Source: org_study_id