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临床试验/NCT01953042
NCT01953042撤回不适用

A Randomized Trial Testing the Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家开始时间: 2013年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in Symptom Severity from Baseline in OCD and Spectrum Measures

研究概览

简要总结

This study will examine the effect of offering information sessions to a randomized group of patients with OCD spectrum disorders. Psychoeducation is a component of first line treatment; though intended to be informative in nature, these psychoeducation services can have a positive effect on quality of life, sense of self-efficacy, functioning and a person's readiness to engage in long term treatment. However, no studies have dismantled and tested the independent effect of psychoeducation from standard treatment such as Cognitive Behavioural Therapy. This study aims to directly test the potential effect of one aspect of CBT that if found to be helpful, can become a distinct early intervention component of care so that as people await services, they can profit from the early benefits associated with attending these information sessions. This study therefore sets out to examine the potential early benefits of providing education about the illness on symptom functioning, quality of life and readiness to engage in more formal treatment. We will offer 4 structured information sessions to individuals allocated to a wait list for services related to the treatment of OCD and OCD Spectrum Disorders in order to directly test the benefit of adding a didactic structured psychoeducation program to our services. The study will be a randomized trial where subjects (N=50) will be randomly assigned to receive either 1) 4 educational sessions covering information on diagnosis, treatment, available resources and self care for OCD and OCD Spectrum Disorders or 2) wait list as per usual with no additional information sessions. The experimental design is a 2 (treatment condition) by 2 (assessment phase) repeated measures factorial design. It is hypothesized that subjects participating in the psychoeducation group compared to the wait list control group will see greater reductions in self-reported measures of symptom severity and improvement in other measures of quality of life, level of functioning, self-efficacy and readiness to engage in treatment. If this study can demonstrate that the addition of a short structured informative intervention of 4 sessions can confer early benefits for those suffering with OCD and OCD spectrum disorders, then it provides another route by which patients can improve this condition specifically while waiting for consultation and the opportunity to receive a more structured, evidence-based treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Referred for treatment services at the Frederick W. Thompson Anxiety Disorder Centre at Sunnybrook Health Sciences Centre
  • Presenting with OCD or OCD Spectrum Disorders
  • Ability to communicate in written and spoken English

排除标准

  • Active substance abuse/dependence
  • Suspected organic pathology
  • Recent suicide attempt/active suicideality
  • Active bipolar or psychotic disorder

研究组 & 干预措施

Waitlist as Per Usual

No Intervention

Wait list as per usual with no additional information sessions

Waitlist and Psychoeducation

Active Comparator

Patients remain on waitlist but also receive 4 additional educational sessions (8 hours each)

干预措施: Psychoeducation (Behavioral)

结局指标

主要结局

Change in Symptom Severity from Baseline in OCD and Spectrum Measures

时间窗: 4 months

OCD measures will include the 18-item Obsessive Compulsive Inventory-Revised (OCI-R), measuring subscales of Washing, Checking, Doubting, Ordering, Obsessions, Hoarding and Neutralizing, as well as a self-report version of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS-SR), a 3 part questionnaire containing a 58 item symptom checklist, identification of the most prominent obsessions and compulsions and a 10 item severity scale. OCD Spectrum measures will include the Body Dysmorphic Disorder-YBOCS, Savings Inventory Revised, PITS, and the MGH scale.

次要结局

  • Change in Quality of Life from Baseline(4 months)

研究者

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

Dr. Neil Rector

Research Scientist, Psychologist, and Director of the Mood and Anxiety Treatment and Research Program

Sunnybrook Health Sciences Centre

研究点 (2)

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