Study Results
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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NOT_YET_RECRUITING
NA
124 participants
INTERVENTIONAL
2024-01-31
2026-07-31
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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CBT with VRET
cognitive-behavioral therapy for gambling disorder
6 sessions of cognitive-behavioral therapy for gambling disorder
virtual reality exposure therapy focus on gambling cues
6 sessions of virtual reality exposure therapy focus on gambling cues
CBT with imaginal ET
cognitive-behavioral therapy for gambling disorder
6 sessions of cognitive-behavioral therapy for gambling disorder
imaginal exposure therapy focus on gambling cues
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
imaginal exposure therapy focus on gambling cues
6 sessions of imaginal exposure therapy focus on gambling cues
virtual reality exposure therapy focus on gambling cues
6 sessions of virtual reality exposure therapy focus on gambling cues
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Lille
OTHER
Responsible Party
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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
CH Boulogne sur mer CSAPA
Boulogne-sur-Mer, , France
CHU de Caen
Caen, , France
Hôpital Fontan, CHU lille
Lille, , France
Assoriation Cédragir Lomme CSAPA
Lomme, , France
CH de l'arrondissement de Montreuil / CSAPA
Montreuil-sur-Mer, , France
CHU Rouen
Rouen, , France
CH de Saint Amand les Eaux
Saint-Amand-les-Eaux, , France
CH Seclin Carvin CSAPA
Seclin, , France
Association GREID ValenciennesCSAPA
Valenciennes, , France
Countries
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Central Contacts
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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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