An interventional study of internet-CBT in Obsessive-Compulsive Disorder, sponsored by University of Sao Paulo General Hospital. Not yet recruiting at 4 sites in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-13.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
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.
367 studies on the registry are indexed under Compulsive Personality Disorder; 67 are open to participants now.
This study's planned enrollment of 140 is above the median of 37 across 306 interventional studies indexed under Compulsive Personality Disorder.
Browse Compulsive Personality Disorder studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Internet cognitive-behavioral therapy
Behavioral: internet-CBT
Treatment as Usual
10 modules on line of I-CBT for OCD
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
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
Plan to share: Yes — All IPD that underlie results in a publication will be shared.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Compulsive Personality Disorder→
University of Sao Paulo General Hospital