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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-CBT | Experimental | Internet cognitive-behavioral therapy |
|
| TU | No Intervention | Treatment as Usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| internet-CBT | Behavioral | 10 modules on line of I-CBT for OCD |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment |
| GAD-7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basic Health System | Indaiatuba | São Paulo | Brazil | |||
| University of Sao Paulo General Hospital. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22348650 | Background | Andersson E, Enander J, Andren P, Hedman E, Ljotsson B, Hursti T, Bergstrom J, Kaldo V, Lindefors N, Andersson G, Ruck C. Internet-based cognitive behaviour therapy for obsessive-compulsive disorder: a randomized controlled trial. Psychol Med. 2012 Oct;42(10):2193-203. doi: 10.1017/S0033291712000244. Epub 2012 Feb 21. | |
| 29080594 |
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All IPD that underlie results in a publication will be shared.
IPD will me available starting after publication.
Upon request from others researchers.
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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It is a pragmatic clinical treatment, randomized-controlled, parallel, open, two-arm trial.
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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. |
| From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment |
| São Paulo |
| São Paulo |
| 05403903 |
| Brazil |
| University of Sao Paulo General Hospital | São Paulo | São Paulo | 05403903 | Brazil |
| Andersson G, Carlbring P. Internet-Assisted Cognitive Behavioral Therapy. Psychiatr Clin North Am. 2017 Dec;40(4):689-700. doi: 10.1016/j.psc.2017.08.004. Epub 2017 Sep 19. |
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| 29937263 | Background | Patel SR, Wheaton MG, Andersson E, Ruck C, Schmidt AB, La Lima CN, Galfavy H, Pascucci O, Myers RW, Dixon LB, Simpson HB. Acceptability, Feasibility, and Effectiveness of Internet-Based Cognitive-Behavioral Therapy for Obsessive-Compulsive Disorder in New York. Behav Ther. 2018 Jul;49(4):631-641. doi: 10.1016/j.beth.2017.09.003. Epub 2017 Sep 15. |
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| 16224614 | Background | Torres AR, Lima MC. [Epidemiology of obsessive-compulsive disorder: a review]. Braz J Psychiatry. 2005 Sep;27(3):237-42. doi: 10.1590/s1516-44462005000300015. Epub 2005 Oct 4. Portuguese. |
| 25273302 | Result | Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E. Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014 Oct;13(3):288-95. doi: 10.1002/wps.20151. |