ZeroOCD: Learn to Overcome Contamination OCD With Your Smartphone: An Augmented Reality Cognitive Behavioral Therapy App for Obsessive-Compulsive Disorder: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 189
- 试验地点
- 4
- 主要终点
- OCD Symptoms (Interview)
研究概览
简要总结
This study is a three-arm randomized controlled trial designed to evaluate the efficacy of a smartphone-based augmented reality (AR) cognitive behavioral therapy (CBT) app, called ZeroOCD, for individuals with elevated contamination-related obsessive-compulsive disorder (OCD) symptoms. The AR-CBT app will be compared to both an active control condition (manualized CBT via videoconferencing) and a waitlist control group.
详细描述
Obsessive-compulsive disorder (OCD) is a prevalent and disabling condition, with contamination fears being one of its most common presentations. While Cognitive-Behavioral Therapy (CBT) with Exposure and Response Prevention (ERP) is a first-line treatment, many individuals face barriers to accessing it, such as cost, stigma, and availability of therapists. This multicenter trial, conducted in the Netherlands, Belgium, Sweden, and Switzerland, will recruit a total of 189 individuals experiencing contamination-related obsessive-compulsive symptoms. Participants will be randomized to one of three study conditions (allocation ratio 2:2:1): The first group (n = 75) receives access to ZeroOCD, an augmented reality (AR) based smartphone application, which provides CBT and ERP for contamination fears, along with three therapist support sessions via videoconferencing. The second group (n = 75) receives weekly CBT for OCD via videoconferencing (nine sessions in total). The third group is a waitlist control group (n = 39), who will receive access to the smartphone application with minimal therapist support on request after 10 weeks in the study. The study aims to evaluate the effectiveness of the ZeroOCD intervention compared to both a waitlist control and videoconferencing CBT, and to assess cost-effectiveness and usability. Assessments are conducted at baseline, 10 weeks post-randomization, and at 6-month follow-up for the intervention groups. Participants in the waitlist group complete assessments at baseline, 10 weeks post-randomization, and receive access to the ZeroOCD intervention 10 weeks after randomization. Further, the waitlist group will complete an assessment 20 weeks post-randomization. The study is a multicenter trial involving participants in Switzerland, the Netherlands, Belgium, and Sweden.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• OCD symptoms, mean score > 7 on the Yale Brown Obsessive Compulsive Scale (Y-BOCS)
- •Fear of contamination OCD symptoms, mean score > 6 on the Padua Inventory contamination fear subscale (PI)
- •Having access to a compatible smartphone
- •Having an internet connection
- •Proficiency in one of the countries' languages (i.e., Dutch/ Flemish, German, or Swedish)
- •Willing to participate in the research study and provide informed consent
排除标准
- •• Having been diagnosed with bipolar or psychotic disorder (self-report)
- •Severe depressive symptoms (Patient Health Questionnaire, PHQ-9, score > 20)
- •Reporting suicidality (PHQ-9, item 9 > 2 points at screening)
- •Fear of contamination due to disorder other than OCD (clinical judgment based on results from the Yale Brown Obsessive Compulsive Scale, Y-BOCS, Generalized Anxiety Disorder-7 items, GAD-7, Short Health Anxiety Inventory, SHAI)
- •Parallel psychological treatment
- •Non-stable dosage of psychoactive medication during the last three months or planned changes during the study period.
研究组 & 干预措施
ZeroOCD AR-CBT App + 3 therapist support sessions
Participants will use the ZeroOCD smartphone application, which delivers 9 modules of augmented reality exposure therapy and cognitive behavioral therapy principles. This group will also receive 3 videoconferencing sessions with a therapist at the beginning, middle, and end of the 10-week treatment period.
干预措施: ZeroOCD (Behavioral)
Videoconferencing CBT
Participants will receive 9 weekly sessions of manualized Cognitive Behavioral Therapy with Exposure and Response Prevention (ERP) delivered via videoconferencing by trained therapists.
干预措施: Videoconferencing CBT (Behavioral)
Waitlist control group
Participants in this group will receive access to the ZeroOCD app with therapist support on request after a 10-week waiting period.
结局指标
主要结局
OCD Symptoms (Interview)
时间窗: At baseline, At 10 weeks, At 20 weeks (only WL condition) At 24 weeks
Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Change from baseline in the observer-rated severity of OCD symptoms. This is a 10-item, clinician-rated scale that provides separate subtotals for the severity of obsessions and compulsions. Total scores range from 0 to 40, with higher scores indicating more severe symptoms. The Y-BOCS is also used for the eligibility (mean score \> 7).
次要结局
- Fear of Contamination(At baseline, At 10 weeks, At 20 weeks (only WL condition) At 24 weeks)
- OCD symptoms (Self-report)(At baseline, During treatment (every week) At 10 weeks, At 24 weeks)
- Negative Effects of Treatment(At 10 weeks (only ZeroOCD and CBT condition), at 20 weeks (only waitlist condition))
- Depression(At baseline, At 10 weeks, At 24 weeks)
- Anxiety(At baseline, At 10 weeks, At 24 weeks)
- Current Distress/Disgust(up to ten weeks)
- Social Functioning(At baseline, At 10 weeks, At 24 weeks)
- Health Related Quality of Life(At baseline, At 10 weeks, At 24 weeks)
- Societal Costs of a Treatment(At baseline, At 10 weeks, At 24 weeks)
- Usability(At 10 weeks (only ZeroOCD condition), At 20 weeks (only WL condition))
- Treatment Satisfaction(At 10 weeks (only intervention groups))
- Realism of AR-Environment(At 10 weeks (only ZeroOCD condition))
- Usage Data(up to ten weeks (only ZeroOCD and waitlist condition))
研究者
Tara Donker
Associate Professor
VU University of Amsterdam