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

Overview

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.

Interventions

• Behavioral internet-CBT
  10 modules on line of I-CBT for OCD

Primary outcome measures

• Y-BOCS [Time frame: From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment]

Secondary outcome measures (2)

• PHQ-9 [Time frame: From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment]
• GAD-7 [Time frame: From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 3 centers

• Basic Health System — Indaiatuba
• University of Sao Paulo General Hospital. — São Paulo
• University of Sao Paulo General Hospital — São Paulo

Publications

• 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. PMID 22348650
• 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. PMID 29080594
• Cuijpers P, Riper H. & Andersson G. Internet- based treatment of depression. Current Opinion in Psychology 4, 131-135 (2015).
• Fairburn CG, Patel V. The impact of digital technology on psychological treatments and their dissemination. Behav Res Ther. 2017 Jan;88:19-25. doi: 10.1016/j.brat.2016.08.012. PMID 28110672
• Fineberg NA, Reghunandanan S, Simpson HB, Phillips KA, Richter MA, Matthews K, Stein DJ, Sareen J, Brown A, Sookman D; Accreditation Task Force of The Canadian Institute for Obsessive Compulsive Disorders. Obsessive-compulsive disorder (OCD): Practical strategies for pharmacological and somatic treatment in adults. Psychiatry Res. 2015 May 30;227(1):114-25. doi: 10.1016/j.psychres.2014.12.003. Epu PMID 25681005
• Gentil AF, Lopes AC, Dougherty DD, Ruck C, Mataix-Cols D, Lukacs TL, Canteras MM, Eskandar EN, Larsson KJ, Hoexter MQ, Batistuzzo MC, Greenberg BD, Miguel EC. Hoarding symptoms and prediction of poor response to limbic system surgery for treatment-refractory obsessive-compulsive disorder. J Neurosurg. 2014 Jul;121(1):123-30. doi: 10.3171/2014.2.JNS131423. Epub 2014 Apr 4. PMID 24702323
• Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007. PMID 2684084
• Karyotaki E, Efthimiou O, Miguel C, Bermpohl FMG, Furukawa TA, Cuijpers P; Individual Patient Data Meta-Analyses for Depression (IPDMA-DE) Collaboration; Riper H, Patel V, Mira A, Gemmil AW, Yeung AS, Lange A, Williams AD, Mackinnon A, Geraedts A, van Straten A, Meyer B, Bjorkelund C, Knaevelsrud C, Beevers CG, Botella C, Strunk DR, Mohr DC, Ebert DD, Kessler D, Richards D, Littlewood E, Forsell E PMID 33471111

Identifiers

NCT: NCT06658756 · 74835123.7.0000.0068

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗