Virtual Reality Exposure Therapy for Obsessive-Compulsive Disorder: A Randomized Controlled Trial in Inpatients (OCD-VRET1)

National Institute of Mental Health, Czech Republic

Status: Enrolling

Conditions: Virtual Reality Cognitive Training; Obsessive-Compulsive Disorder; Cognitive Behavior Therapy; Virtual Reality Exposure Therapy

Treatments: Behavioral: Cognitive flexibility training; Behavioral: Exposure Therapy (Virtual Reality); Behavioral: Standard CBT program without VR interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT07245134

NU23-04-00402_Study1

Details and patient eligibility

About

The aim of this study is to evaluate the efficacy of virtual reality exposure therapy (VRET) as a treatment for obsessive-compulsive disorder (OCD). Participants are randomly assigned to one of the following interventions: a) exposure condition - the group with a standard CBT program enriched with exposure therapy in VR (VRET), b) control condition 1 - the group with a standard CBT program enriched with VR cognitive training aimed at cognitive flexibility or c) control condition 2 - standard CBT program without any additional VR intervention. The treatment effect will be evaluated using pre/post assessments, as well as monitoring adherence to exposure and response prevention assignments.

Full description

The virtual environment of so called "OCD house" is used as a tool for the intervention in the experimental group. Immersive VR glasses HTC Vive Pro are used to visualize the virtual 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 behavior. 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 the clients.

The therapeutic application enables movement and direct interaction with stimuli in the environment of the virtual house and garden, thanks to a set of handhold controllers. Direct head and body rotations and small body 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 the computer and screen connected to the headset, and advise the patient where necessary. The level of difficulty is gradually increased during the progress of the therapy.

Enrollment: 62 estimated patients

Sex: All

Ages: 17 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 3 patient groups

Virtual reality exposure

Experimental group

Description:

Participants complete 6-week CBT program with five 30-40-minute sessions of exposure administered via a virtual reality headset (once a week). The intervention involves exposure to various symptom provoking scenarios in the virtual house environment - "OCD house". Scenarios can be adjusted to distinct OCD dimensions: contamination/cleaning, fear-of-harm/checking, symmetry/ordering. Stimuli can be also freely combined across dimensions, so that the scenarios fit to individual needs.

Treatment:

Behavioral: Exposure Therapy (Virtual Reality)

Cognitive flexibility training

Active Comparator group

Description:

Control group attends 6-week CBT program with five sessions of 30-40 minutes of cognitive training via virtual reality headset using "VRcity" cognitive training games.

Treatment:

Behavioral: Cognitive flexibility training

Standard CBT without additional VR treatment

Active Comparator group

Description:

Control group completes the standard 6-week CBT program only, with no VR sessions.

Treatment:

Behavioral: Standard CBT program without VR interventions