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

National Institute of Mental Health, Czech Republic62 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Interventions

Exposure Therapy (Virtual Reality)BEHAVIORAL

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.

Cognitive flexibility trainingBEHAVIORAL

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.

Standard CBT program without VR interventionsBEHAVIORAL

Standart CBT program (performed in all groups). The program involves regular group and individual psychotherapy sessions 5 days per 6 weeks.

Eligibility

Sex: ALLMin age: 17 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

The Y-BOCS is a 19-item scale assessing the severity of obsessive-compulsive symptoms. Raw score range from 0 to 40, where 0 = no symptoms and 40 = very severe symptoms with highly impaired daily functioning.

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)

The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.

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)

BAI is an inventory of anxiety symptoms with 18 items rated on a 5-point Likert scale (0-4). Score range from 0 to 72, with higher scores indicating more severe anxiety symptoms.

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

Four questions aimed at gathering information about how patients managed to perform exposures during the past week and to what extent the skills acquired during the VR exposure therapy were useful.

Time frame: Immediately before each session (S1-S5) and 2 months after the last session in the follow-up measurement.

Secondary Outcomes

The Spielberger State-Trait Anxiety Inventory-X2 (STAI-X2)

The Spielberger State-Trait Anxiety Inventory-X2 (STAI-X2) is used to measure self-reported symptoms of trait anxiety with higher score indicating higher anxiety levels (score range 20-80).

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)

The 6-item short form of the Spielberger State-Trait Anxiety Inventory is used to measure self-reported symptoms of state anxiety with higher score indicating higher anxiety levels.

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)

The SUDS is a visual analog scale in which the participant rates his/her anxiety/discomfort based on a range between 1 (no anxiety/discomfort) and 10 (very severe anxiety/discomfort).

Time frame: During In-Sessions: all sessions S1-S5

Anxiety Hierarchy

The patient is asked to develope a hierarchy of feared situations ranging from most-feared at the top to least-feared at the bottom. Then, he/she rates anticipated fear, anxiety or distress for each item (score 1-10, with higher score indicating higher anxiety) - according to how distressing they feel it would be to encounter that situation. The hierarchy is used to guide a process of VRET sessions.

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)

BIS is a 30-item scale used for self-assessment of impulsivity. Participants rate each item on a 4-point scale. Total score range from 30 to 120, where higher scores indicate higher impulsivity.

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

CFI is self-report measure of the type of cognitive flexibility necessary for replace maladaptive thoughts with more balanced thinking. It has 20-items that participants evaluate on a 7-point Likert scale. The total score ranges from 20 to 140 and higher scores indicate more cognitive flexibility.