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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNational Institute of Mental Health, Czech Republic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of OCD (F42) using currently valid DSM-V and ICD-11

Fluent in Czech

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • exposure therapy in virtual reality

    Behavioral

    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.

  • Wait list

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Within-subject comparison of a waiting list condition with exposure therapy in VRExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) self report version

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) 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.
2

The Beck Depression Inventory

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: 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.
3

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: 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.
4

Hierarchy of fears

Patients describe and rate their most feared situations or stimuli on a 10-point scale (1-10).

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.

Secondary outcomes

1

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: week 1-5 of experimental VRET condition
2

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
Before In-Sessions: week 1-5 of experimental VRET condition
3

The Igroup Presence Questionnaire (IPQ)

The scale includes 3 subscales SP (spatial presence), INV (involvement) and REAL (experienced realism) with score range 0-7. Higher scores indication higher sense of presence. This measure might be positivelly associated with positive outcome.

Time frame
Immediately after the first session of VR exposure therapy.
4

Simulator Sickness Questionnaire (SSQ)

The scale evaluates cybersickness symptoms in three subscales: nausea (N), oculomotor disturbance (O), disorientation (D). Total simulator sickness raw score 0-48 (adjusted total score 0-180). Higher scores on each scale indicatestronger perceptions of the underlying sickness symptoms and aretherefore undesired. This measure might be negatively associated with positive outcome and sense of presence.

Time frame
Immediately after the first session of VR exposure therapy.

Other outcomes

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