Virtual Reality Exposure Therapy for Obsessive-Compulsive Disorder: Outpatients Trial

Official title

Virtual Reality Exposure Therapy in Patients With Obsessive-Compulsive Disorder: A Randomized Controlled Trial in Outpatients

Overview

The aim of this study is to evaluate the efficacy of virtual reality exposure therapy (VRET) as a treatment for obsessive-compulsive disorder (OCD). This study focuses on patients receiving treatment in outpatient psychiatry or clinical psychology settings, utilizing a within-subject design for comparison. Patients first complete informed consent and baseline questionnaires and are placed on a waiting list for five weeks. After this period, they are reassigned to the active (experimental) group, which will receive five sessions of exposure therapy in virtual reality over a subsequent five-week period. The treatment effect will be evaluated using pre/post assessments, as well as monitoring adherence to exposure and response prevention assignments.

Detailed description

The virtual environment of so called "OCD house" is used as a tool for the therapy. Immersive VR glasses Meta Quest 2 are used to visualize the environment.

During exposure therapy, relevant virtual stimuli can be freely combined involving common objects and situations in the home that may trigger OCD symptoms and hoarding. Target stimuli (VR elements) are divided into several sets corresponding to OCD subtypes. During the session, the therapist can modify the level of difficulty via four standardized levels according to the individual needs of clients.

The therapeutic application enables direct interaction with stimuli in the environment of the virtual house and garden, thanks to hand tracking. The hand tracking and hand gestures are used also to control the movement in the environment by the patients, but direct head and body rotations and small movements are enabled by the VR headset. The psychotherapist can follow the patient actions and control the settings of the environment (e.g.selection of relevant stimuli, level of difficulty) using a streaming app on the tablet or a mobile phone and advise the patient where necessary. The level of difficulty is gradually increased during the progress of the therapy.

Interventions

• Behavioral exposure therapy in virtual reality
  Participants complete five 30-40-minute sessions of exposure therapy administered via a virtual reality headset once a week. The exposure involves exposure to various symptom-provoking scenarios in the virtual house environment. Scenarios can be adjusted to distinct OCD dimensions: contamination/cleaning, fear-of-harm/checking symmetry/ordering, and also to symptoms of hoarding. Stimuli can be also freely combined across different dimensions, so that the scenarios fit the individual needs.
• Other Wait list
  The patients are assigned to a waitlist period for 5 weeks. During this period they are not allowed to change any treatment (phramacotherapy and/or psychoterapy as usual) started prior to the trial.

Primary outcome measures

• The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) self report version [Time frame: Applied repeatedly: 1) Before the assignment to the waitlist condition, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session.]
• The Beck Depression Inventory [Time frame: Applied repeatedly: 1) Before the assignment to the waitlist condition, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session.]
• Beck Anxiety Inventory (BAI) [Time frame: Applied repeatedly: 1) Before the assignment to the waitlist condition, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session.]
• Hierarchy of fears [Time frame: Applied repeatedly: 1) Before the assignment to the waitlist condition, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session.]
• The Spielberger State-Trait Anxiety Inventory-X2 (STAI-X2) [Time frame: Applied repeatedly: 1) Before the assignment to the waitlist, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session]

Secondary outcome measures (4)

• Subjective Units of Distress Scale (SUDS) [Time frame: During In-Sessions: week 1-5 of experimental VRET condition]
• Adherence to exposures [Time frame: Before In-Sessions: week 1-5 of experimental VRET condition]
• The Igroup Presence Questionnaire (IPQ) [Time frame: Immediately after the first session of VR exposure therapy.]
• Simulator Sickness Questionnaire (SSQ) [Time frame: Immediately after the first session of VR exposure therapy.]

Eligibility criteria

Inclusion criteria

• Diagnosis of OCD (F42) using currently valid DSM-V and ICD-11
• Fluent in Czech

Exclusion criteria

• Any other psychiatric, neurological and serious somatic illness
• Substance abuse
• Psychotropic medication (e.g. benzodiazepines) except antidepressants, antipsychotic medication and hypnotics.
• Contradictions to using a virtual reality (e.g., epilepsy, balance problems)
• Pregnancy
• Cardiostimulator and mental implants

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Czechia · 1 center

• Nationa Institute of Mental Health — Klecany

Identifiers

NCT: NCT07206199 · NU23-04-00402-Study2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗