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NCT Number: NCT06658756

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Basic Health System, Indaiatuba, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internet-CBT

Behavioral

10 modules on line of I-CBT for OCD

Primary outcomes

  1. Y-BOCS

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

    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.

Secondary outcomes

  1. PHQ-9

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

    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

  2. GAD-7

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

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Implementation of Internet-Based Psychotherapy for Obsessive-Compulsive Disorder (OCD) in Primary Health Care in Two Cities in the State of São Paulo

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 26, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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