跳至主要内容
临床试验/NCT03846076
NCT03846076已完成不适用

Investigating Treatment and Information Processing in Olfactory Reference Syndrome: A Pilot Study

Volen Ivanov2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
Yale-Brown Obsessive Compulsive Scale Modified for olfactory reference syndrome (ORS-YBOCS)

研究概览

简要总结

The primary aim of the study is to test the feasibility and efficacy of, a manual based, Internet-delivered, cognitive behaviour therapy (CBT) for patients with Olfactory Reference Syndrome (ORS) who live in Sweden. The secondary aim is to investigate smell sensitivity and body odor in these ORS-patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary diagnosis of ORS
  • Outpatients
  • Male or female
  • Signed informed consent
  • Have regular access to a computer with Internet access and skills to use the web

排除标准

  • Not able to read or understand the basics of the ICBT self-help material
  • Psychotropic medication changes within two months prior to treatment
  • Completed CBT for ORS within last 12 months
  • Ongoing substance dependence or misuse
  • Lifetime bipolar disorder or psychosis
  • Suicidal ideation
  • Axis II diagnosis that could jeopardize treatment participation
  • Serious physical illness that will be an obstacle in ICBT
  • Other ongoing psychological treatments that could affect ORS symptoms
  • Epilepsia

结局指标

主要结局

Yale-Brown Obsessive Compulsive Scale Modified for olfactory reference syndrome (ORS-YBOCS)

时间窗: Change from baseline (week 0) to post-treatment (week 10).

The instrument is a 12-item clinician-administered scale rating the severity of ORS symptoms during the past week. Each item is scored along a Likert scale ranging from 0 (least extreme) to 4 (most extreme), with higher total scores indicating more severe ORS symptoms (range 0-48).

次要结局

  • The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)(Change from baseline (week 0) to post-treatment (week 10).)
  • Yale-Brown Obsessive Compulsive Scale Modified for olfactory reference syndrome - Self Report (ORS-YBOCS-SR)(Change from baseline (week 0) to post-treatment (week 10).)

研究者

发起方
Volen Ivanov
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Volen Ivanov

Principal Investigator

Karolinska Institutet

研究点 (2)

Loading locations...

相似试验

Internet Delivered CBT for Olfactory Reference... | 临床试验