Clinical trial NCT06658756: Implementation of Internet-Based Psychotherapy for OCD in Primary Health Care in Two Cities in the State of São Paulo
Official title: Implementation of Internet-Based Psychotherapy for Obsessive-Compulsive Disorder (OCD) in Primary Health Care in Two Cities in the State of São Paulo
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2024-10-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a pragmatic clinical treatment, randomized-controlled, parallel, open, two-arm trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Y-BOCS
timeFrame: From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment
Secondary outcomes:
measure: PHQ-9
timeFrame: From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment
measure: GAD-7
timeFrame: From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
state: SP
city: Indaiatuba
country: Brazil
facility: Basic Health System
state: São Paulo
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
city: São Paulo
country: Brazil
facility: University of Sao Paulo General Hospital.
Study officials:
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