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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Immediately before each session (S1-S5) and 2 months after the last session in the follow-up measurement.]

Вторичные конечные точки (6)

• The Spielberger State-Trait Anxiety Inventory-X2 (STAI-X2) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: During In-Sessions: all sessions S1-S5]
• Anxiety Hierarchy [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Immediately before the first (S1), after the last (S5) session and 2 months after the last session in the follow-up measurement.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чехия · 1 центр

• National Institute of Mental Health — Klecany

Идентификаторы

NCT: NCT07245134 · NU23-04-00402_Study1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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