Concentrated Exposure Treatment (cET) for Obsessive Compulsive Disorder (OCD). A Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 主要终点
- Changes i OCD diagnostic status (DSM-5) as measured by SCID
研究概览
简要总结
Obsessive Compulsive Disorder (OCD) often becomes chronic if not treated. Exposure and response prevention (ERP) is recommended psychological treatment. The OCD-team at Haukeland University hospital has developed a concentrated 4-day treatment format which has been evaluated as part of standard care. Next step in the methodological development is to conduct a randomized controlled trial where the 4-day format is compared to self-help and waiting list. The study will be conducted at Solvang DPS, Sørlandet Hospital. Participants (16 in each group) are ordinary patients (>18 yrs) entitled to care in the specialist health care.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OCD-patients referred to the OCD-team at Sørlandet Sykehus, Solvang DPS will be included.
- •Inclusion criteria
- •Outpatients
- •≥ 18 years of age
- •Fulfilling diagnostic criteria of OCD according to the DSM-5
- •Y-BOCS ≥ 16
- •Fluent in Norwegian
- •Signed informed consent
排除标准
- •OCD symptoms primarily associated with hoarding
- •Ongoing substance abuse/dependence
- •Bipolar disorder or psychosis
- •Ongoing suicidal ideation
- •Mental Retardation, based on previous medical history
- •If using antidepressants:
- •Not on stable dosage 4 weeks before the intervention
- •Unwilling to remain on stable dosage during the four intervention days
- •Unwilling to refrain from anxiety reducing substances, such as anxiolytics (e.g. benzodiazepines) and alcohol during the two days of exposure.
- •Patients living > 1.5 hour drive by car/ train from the treatment location.
- •Patients with a BMI-index considered too low for participation in psychological treatment
- •Patients with a full course of prior CBT for OCD.
结局指标
主要结局
Changes i OCD diagnostic status (DSM-5) as measured by SCID
时间窗: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
Changes in Y-BOCS from pre cET-treatment to post treatment/ waiting list/ self-help
时间窗: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
Y-BOCS changes will for all conditions be calculated by two approaches which will be compared.
次要结局
- Well-being(Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up)
- Generalized anxiety(Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up)
- Work and social adjustment(Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up)
- Client satisfaction(1 week post Concentrated Exposure Treatment)
- Depression(Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up)
- Insomnia(Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, six months follow up)