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.
• 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
• 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
ZeroOCD
BehavioralThe ZeroOCD app contains the following components: psychoeducation, detecting obsessive thoughts, coping with obsessions, goal setting, fear curve explanation, exposure with AR, re-exposure with AR, exposure hierarchy, exposure in real-life, re-exposure in real life and relapse prevention
Videoconferencing CBT
BehavioralVideoconferencing CBT contains the following chapters: psychoeducation, detecting obsessive thoughts, coping with obsessions, goal setting, fear curve explanation, exposure hierarchy, exposure in real-life, re-exposure in real life and relapse prevention
OCD Symptoms (Interview)
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).
OCD symptoms (Self-report)
4-item Obsessive-Compulsive Inventory (OCI-4): Change from baseline in the self-reported OCD symptom severity. This shorter form of the OCI-R consists of 4 Items that quantify the symptom severity related to OCD. Each item is rated on a scale from 0 to 4, with total scores ranging from 0 to 16, with higher scores indicating more severe symptoms.
Fear of Contamination
Padua Inventory (PI) Contamination Fear Subscale: Change from baseline in the self-reported fear of contamination. This is a 10-item subscale that quantifies the severity of contamination-related obsessions, with each item rated on a 5-point Likert scale. A score of 6 or higher on this scale is an inclusion criterion for the study. The PI is also used for the eligibility (mean score \> 6).
Depression
Patient Health Questionnaire-9 (PHQ-9): Change from baseline in self-reported depressive symptom severity. This is a 9-item measure where each item corresponds to a DSM-5 criterion for major depression. Scores range from 0 to 27, and a score of \>20 is an exclusion criterion. The PHQ-9 is also used for the eligibility (severe depressive symptoms: score \> 20; suicidality: item 9 score \> 2).
Anxiety
Generalized Anxiety Disorder 7-item scale (GAD-7): Change from baseline in self-reported anxiety symptom severity. This is a 7-item measure with scores ranging from 0 to 21. It will also be used at baseline to help determine if contamination fears are due to GAD rather than OCD.
Reasons for discontinuation
Reasons for discontinuation: to understand why participants stop with the treatment before the end of the treatment
Socio-demographic information
Socio-demographic questionnaire: To gather participant characteristics and demographics at the start of the study. This questionnaire collects information about participants' age, gender, education level, marital status, employment status, and treatment preference. It also gathers information on current or past psychological treatment and medication to confirm eligibility.
Health Anxiety
Short Health Anxiety Inventory (SHAI): A self-report measure to assess the presence of health anxiety at baseline, which is an exclusion criterion if judged to be the primary driver of contamination fears. This is an 18-item measure rated on a scale from 0 to 3.
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VU University of Amsterdam
Lead sponsor
University of Bern
Collaborator
Stockholm University
Collaborator
Thomas More University of Applied Sciences
Collaborator
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