Implementation of Internet-Based Psychotherapy for Obsessive-Compulsive Disorder (OCD) in Primary Health Care in Two Cities in the State of São Paulo
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Y-BOCS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary diagnosis of OCD according to the DSM-5 (American Psychiatric Association, 2013);
- •internet access.
排除标准
- •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.
结局指标
主要结局
Y-BOCS
时间窗: 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.
次要结局
- PHQ-9(From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment)
- GAD-7(From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment)