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临床试验/NCT00679003
NCT00679003已完成不适用

Psychosocial Intervention for Children With IBD

University of Washington0 个研究点目标入组 190 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
190
主要终点
Functional Disability Inventory

研究概览

简要总结

Inflammatory Bowel Disease (Crohn's disease and ulcerative colitis) often results in significant life disruption, hospitalization and surgery. While psychosocial factors are not believed to cause IBD, such factors can contribute to the ability of individuals with IBD to cope with the disease, and ineffective coping may lead to the exacerbation of IBD symptoms. The goal of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with IBD. The primary outcomes of interest are IBD symptoms, medical visits, quality of life, and overall disability.

详细描述

Inflammatory Bowel Disease (Crohn's and ulcerative colitis; IBD), a serious medical condition that affects children and adolescents, is often associated with high rates of health care utilization and disability, including school absences. While psychosocial factors are not believed to cause IBD, research suggests that they may increase illness-related dysfunction. Prior studies suggest that response to chronic illness is, in part, acquired during childhood through social learning processes and may be modified with psychosocial interventions. This randomized controlled trial will compare a social learning and cognitive behavior therapy (SLCBT) treatment to an education and support condition (ES). 180 children with IBD will be recruited and followed for 12 months. It is hypothesized that SLCBT participants, compared to those in the ES condition, will, at one-year follow-up: 1) exhibit greater decreases in IBD symptoms, medical visits for IBD, and functional disability, and greater increases in quality of life; 2) demonstrate greater use of cognitive coping, relaxation and stress management skills, and their parents will demonstrate greater reductions in maladaptive responses to illness behavior; and 3) exhibit greater reductions in anxiety, depression, and somatization. Results will lead to innovative interventions for IBD and other chronic childhood medical conditions.

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 (Participant)

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child has been diagnosed for at least 3 months
  • Child age is 8-17
  • Child has lived with primary caregiver full-time for at least the past 5 years and for at least half of his/ her lifetime
  • Child is medically approved to engage in normal daily activities

排除标准

  • Chronic disease other than IBD (e.g., pancreatitis, diabetes, epilepsy)
  • Major surgery in past year unrelated to IBD
  • Developmental disabilities that require full-time special education or that impair ability to respond to treatment

结局指标

主要结局

Functional Disability Inventory

时间窗: Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment

次要结局

  • Pediatric Quality of Life(Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12 months post-treatment)
  • Health care utilization for IBD(Baseline, 3 months, 6 months and 12 months post-treatment)
  • School absences(Baseline, 3 months, 6 months and 12 months post-treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rona Levy

Professor

University of Washington

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