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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17-55
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). 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.

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

Parallel

Treatments tested in this trial

  • 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 training

    Behavioral

    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 interventions

    Behavioral

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

Treatment groups

62 Participants
are divided into 3 treatment groups
Group A: Virtual reality exposureExperimental treatment 1 intervention
Group B: Cognitive flexibility trainingActive comparator 1 intervention
Group C: Standard CBT without additional VR treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).
2

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.
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 for 5 weeks of the intervention (once per week) and 2 months after the last session in the follow-up measurement.
4

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

1

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.
2

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)
3

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
4

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.

Other outcomes

1

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 second session (S2)
2

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 indicate stronger perceptions of the underlying sickness symptoms and are therefore undesired. This measure might be negatively associated with positive outcome and sense of presence.

Time frame
Immediately after second session (S2)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.