Virtual Reality Exposure Therapy for Gambling Disorder

NCT ID: NCT04467502

Last Updated: 2024-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2026-07-31

Brief Summary

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Gambling disorder (GD) is recognized as an addictive disorder in the DSM-5. Craving is a core phenomenon in addiction that can lead to relapse in problem gambling for pathological gamblers. Exposure Therapy (ET) focuses on craving in addiction treatment. ET in Cognitive-Behavioral Therapy (CBT) is based on classical conditioning that addresses the association between contextual cues and the craving response. ET helps the patient to reduce craving when faced with cues triggering craving. ET includes in vivo exposure and imaginal exposure. The literature recommends being as close as possible to the context of addiction to facilitate the extinction of craving but in vivo ET is complicated to perform. For GD, in outpatient consultation, bringing a patient to a casino presents obstacles (e.g., time, human and financial cost, agreement with casino for therapy).

The study will be to assess the effectiveness of Virtual Reality Exposure Therapy (VRET) in a virtual gambling environment. Various trials show that VRET is no more or less effective than classical ET in CBT but has other advantages for motivation to treatment. This research aims to compare efficacy between CBT with VRET and CBT with imaginal exposure for treatment of GD in a multicenter, randomized, controlled, non-inferiority clinical trial.

Detailed Description

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Main aim:

Show, within patients seeking care for GD, that VRET integrated with CBT is non-inferior to imaginal ET integrated with CBT on GD symptom reduction at the end of 12 treatment sessions.

Secondary objectives:

1. Show that VRET integrated with CBT is non-inferior to imaginal ET integrated with CBT on GD symptom reduction during the first 12 months post-treatment.
2. Compare the effect of the two therapeutic strategies on GD symptoms (measured by complementary assessments to that used in the main aim), at the end of treatment and during the first 12 months post-treatment.
3. Show the efficacy of VRET integrated with CBT compared to imaginal ET integrated with CBT on gambling behavior, craving, and gambling-related cognitions at the end of treatment and during the first 12 months post-treatment.
4. Show the efficacy of VRET integrated with CBT compared to imaginal ET integrated with CBT on the evolution of anxiety and depressive symptoms at the end of treatment and during the first 12 months post-treatment.
5. Compare the quality of the two therapeutic strategies at the end of treatment.

Conditions

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Gambling Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CBT with VRET

Group Type EXPERIMENTAL

cognitive-behavioral therapy for gambling disorder

Intervention Type OTHER

6 sessions of cognitive-behavioral therapy for gambling disorder

virtual reality exposure therapy focus on gambling cues

Intervention Type OTHER

6 sessions of virtual reality exposure therapy focus on gambling cues

CBT with imaginal ET

Group Type ACTIVE_COMPARATOR

cognitive-behavioral therapy for gambling disorder

Intervention Type OTHER

6 sessions of cognitive-behavioral therapy for gambling disorder

imaginal exposure therapy focus on gambling cues

Intervention Type OTHER

6 sessions of imaginal exposure therapy focus on gambling cues

Interventions

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cognitive-behavioral therapy for gambling disorder

6 sessions of cognitive-behavioral therapy for gambling disorder

Intervention Type OTHER

imaginal exposure therapy focus on gambling cues

6 sessions of imaginal exposure therapy focus on gambling cues

Intervention Type OTHER

virtual reality exposure therapy focus on gambling cues

6 sessions of virtual reality exposure therapy focus on gambling cues

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Seek treatment for GD within one of health care facilities participating in the research (first request for treatment and not patients already receiving treatment for gambling disorder in the care center).
* Meet a current diagnosis of gambling disorder according to DSM-5 criteria and with a South Oaks Gambling Screen (SOGS) score ≥ 5
* Meet a casino gambling behavior with a casino gambling frequency ≥ 1 time every two months during the last 12 months
* Have a sufficient understanding of French for therapy
* Beneficiary of the French social security system
* Give an informed consent to participate
* Willing to comply with all study procedures and duration

Exclusion Criteria

* Visual disturbance making impossible the use of virtual reality equipment (e.g. advanced retinal degeneration, central scotoma, age-related macular degeneration)
* Pregnant woman
* Minor or adult under guardianship, conservatorship, under judicial protection, persons deprived of their liberty
* Balance disorder (e.g. cerebellar disorder, inner ear disorder)
* Photosensitive epilepsy
* Refusal to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre TAQUET, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CHU Amiens-Picardie

Amiens, , France

Site Status

CH Boulogne sur mer CSAPA

Boulogne-sur-Mer, , France

Site Status

CHU de Caen

Caen, , France

Site Status

Hôpital Fontan, CHU lille

Lille, , France

Site Status

Assoriation Cédragir Lomme CSAPA

Lomme, , France

Site Status

CH de l'arrondissement de Montreuil / CSAPA

Montreuil-sur-Mer, , France

Site Status

CHU Rouen

Rouen, , France

Site Status

CH de Saint Amand les Eaux

Saint-Amand-les-Eaux, , France

Site Status

CH Seclin Carvin CSAPA

Seclin, , France

Site Status

Association GREID ValenciennesCSAPA

Valenciennes, , France

Site Status

Countries

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France

Central Contacts

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Pierre TAQUET, PhD

Role: CONTACT

0320445838 ext. +33

Other Identifiers

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2020-A02710-39

Identifier Type: OTHER

Identifier Source: secondary_id

2020_02

Identifier Type: -

Identifier Source: org_study_id

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