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Recruiting NCT07245134

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

No phase Interventional Obsessive-Compulsive Disorder Virtual Reality Exposure Therapy Virtual Reality Cognitive Training Cognitive Behavior Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exposure Therapy (Virtual Reality), Cognitive flexibility training, Standard CBT program without VR interventions.
Who it may be relevant to
Registry conditions: Obsessive-Compulsive Disorder, Virtual Reality Exposure Therapy, Virtual Reality Cognitive Training, Cognitive Behavior Therapy. Basic parameters: 17 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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). 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.

Detailed 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.

Interventions

  • Behavioral Exposure Therapy (Virtual Reality)
    Virtual reality scenarios consists of exposures to OCD symptom provoking stimuli and response prevention (e.g. having dirty hands without washing them immediately) with the support of the therapist. The goal of VRET is sufficient reduction in anxiety and acceleration of progress in classical CBT.
  • Behavioral Cognitive flexibility training
    Participants play series of various cognitive games previously developed in NIMH aimed at cognitive flexibility. Games are presented using immersive VR (HTC vive headset). The set includes for instance Go/No-go paradigm with a shooting range addressing inhibitory control, Flies - hit a fly game addressing set-shifting and Castle game addressing spatial memory and reversal learning.
  • Behavioral Standard CBT program without VR interventions
    Standart CBT program (performed in all groups). The program involves regular group and individual psychotherapy sessions 5 days per 6 weeks.

Primary outcome measures

  • The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [Time frame: Applied repeatedly: 1) At the baseline - Before the start of the first therapy session (S1), 2) Post-intervention - after the last session (S5) and 3) 2 months after the last session in the follow-up measurement (subjective Y-BOCS).]
  • The Beck Depression Inventory (BDI) [Time frame: Applied repeatedly for 5 weeks of the intervention (once per week) and 2 months after the last session in the follow-up measurement.]
  • Beck Anxiety Inventory (BAI) [Time frame: Applied repeatedly for 5 weeks of the intervention (once per week) and 2 months after the last session in the follow-up measurement.]
  • Adherence to exposures [Time frame: Immediately before each session (S1-S5) and 2 months after the last session in the follow-up measurement.]
Secondary outcome measures (6)
  • The Spielberger State-Trait Anxiety Inventory-X2 (STAI-X2) [Time frame: 1) At the baseline - Before the start of the first therapy session (S1), 2) Post-intervention - after the last session (S5) and 3) 2 months after the last session in the follow-up measurement.]
  • Six-item State-Trait Anxiety Inventory (STAI-6) [Time frame: Applied repeatedly during the intervention - twice during each of the 5 weekly sessions - Immediately Pre- and Post-Session (all sessions S1-S5)]
  • Subjective Units of Distress Scale (SUDS) [Time frame: During In-Sessions: all sessions S1-S5]
  • Anxiety Hierarchy [Time frame: Baseline - Immediately before first (S1), posttreatment - after the last session (S5) + (Controlling for Baseline Score) and 2 months after the last session in the follow-up measurement.]
  • Barratt Impusiveness Scale (BIS-11) [Time frame: Immediately before the first (S1), after the last (S5) session and 2 months after the last session in the follow-up measurement.]
  • Cognitive Flexibility Inventory [Time frame: Immediately before the first (S1), after the last (S5) session and 2 months after the last session in the follow-up measurement.]

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
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • National Institute of Mental Health — Klecany

Identifiers

NCT: NCT07245134 · NU23-04-00402_Study1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗