Treatment of Pediatric OCD for SRI Partial Responders
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 3
- 主要终点
- Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
研究概览
简要总结
This study will determine whether cognitive behavioral therapy delivered by either psychologists or psychiatrists can improve the effectiveness of serotonin reuptake inhibitor treatment in children with obsessive compulsive disorder.
详细描述
The vast majority of children with obsessive compulsive disorder (OCD) are given serotonin reuptake inhibitor (SRI) drugs as initial treatment. However, recommended doses of these medications leave many children with clinically significant residual symptoms. Health care experts typically recommend augmenting SRI treatment with cognitive behavioral therapy (CBT), yet this recommendation is seldom followed. This study will contrast two CBT augmentation strategies to continued medication management alone: CBT administered by a psychologist and instructional CBT (I-CBT)administered by a psychiatrist in the context of ongoing medication management.
All patients in the trial will be eligible to receive a full course of CBT by study end. Participants in this study will be randomly assigned to receive CBT, I-CBT or continued medication management. All participants will continue their SRI treatment for 12 weeks. After the 12-week treatment period, participants who received I-CBT or medication management alone and who remain symptomatic will be given CBT as will participants who are asymptomatic but relapse within 6 months after treatment. Assessments will be conducted at Weeks 0, 4, 8, and 12. Follow-up assessments will be conducted at 3 and 6 months post-treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV Diagnosis of obsessive compulsive disorder
- •CYBOCS total score greater than 16
排除标准
- •Other primary or co-primary psychiatric disorder
- •Pervasive developmental disorder or disorders, including Asperger's Syndrome
- •Thought disorder
- •Prior failed trial of cognitive-behavioral therapy
- •Has pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS) or maintenance antibiotic for obsessive-compulsive disorder
- •Mental retardation
- •Pregnancy
研究组 & 干预措施
MedMgmt+CBT
Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist.
干预措施: Serotonin reuptake inhibitors management (Drug)
MedMgmt+CBT
Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist.
干预措施: Cognitive behavioral therapy by a psychologist (Behavioral)
MedMgmt+I-CBT
Participants will receive the following interventions 1)SRI medication management plus, 2) instructional cognitive behavioral therapy. Both of these will be implemented by the same psychiatrist.
干预措施: Serotonin reuptake inhibitors management (Drug)
MedMgmt+I-CBT
Participants will receive the following interventions 1)SRI medication management plus, 2) instructional cognitive behavioral therapy. Both of these will be implemented by the same psychiatrist.
干预措施: Instructional cognitive behavioral therapy by a psychiatrist (Behavioral)
MedMgmt Only
Participants will receive the intervention SRI medication management with a psychiatrist
干预措施: Serotonin reuptake inhibitors management (Drug)
结局指标
主要结局
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
时间窗: Measured at baseline and Week 12.
OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 - 20), and a composite symptom severity score (0 to 40). Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure.
次要结局
- Child Obsessive -Compulsive Impact Scale (COIS)(Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up)
- Child Depression Inventory(Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up)
- Pediatric Adverse Event Rating Scale (PAERS)(Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up)