NCT04467502

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jul 2023Jul 2027

First Submitted

Initial submission to the registry

June 29, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
3 years until next milestone

Study Start

First participant enrolled

July 12, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

June 29, 2020

Last Update Submit

May 11, 2026

Conditions

Gambling Disorder

Keywords

Exposure therapyvirtual realitycognitive behavioral therapypathological gamblingCBT

Outcome Measures

Primary Outcomes (1)

  • Change in South Oaks Gambling Screen (SOGS) between baseline and end of treatment (12 sessions, 6 months)

    The SOGS is a 20-item instrument used to screen for pathological gambling. The SOGS is scored by summing the number of items endorsed out of 20 and a cut score of 5 or more indicates a probable pathological gambling. The score ranges from 0 to 20.

    at the end of treatment (an average of 6 months)

Secondary Outcomes (14)

  • Change in South Oaks Gambling Screen (SOGS) between baseline and follow-up at 3, 6 and 12 months after the end of treatment

    at baseline, and through study completion, an average of 18 months

  • Change in gambling disorder symptoms between baseline, end of treatment and follow-up assessed by the following criteria: number of DSM-5 criteria for GD

    at baseline, and through study completion, an average of 18 months

  • Change in gambling disorder symptoms between baseline, end of treatment and follow-up assessed by the following criteria: Problem Gambling Severity Index (PGSI)

    at baseline, and through study completion, an average of 18 months

  • Change in gambling behavior assessed by gambling frequency during the last month

    at baseline, and through study completion, an average of 18 months

  • Change in gambling behavior assessed by amount of money spent in gambling during the last month

    at baseline, and through study completion, an average of 18 months

  • +9 more secondary outcomes

Study Arms (2)

CBT with VRET

EXPERIMENTAL
Other: cognitive-behavioral therapy for gambling disorderOther: virtual reality exposure therapy focus on gambling cues

CBT with imaginal ET

ACTIVE COMPARATOR
Other: cognitive-behavioral therapy for gambling disorderOther: imaginal exposure therapy focus on gambling cues

Interventions

imaginal exposure therapy focus on gambling cuesOTHER

6 sessions of imaginal exposure therapy focus on gambling cues

CBT with imaginal ET
cognitive-behavioral therapy for gambling disorderOTHER

6 sessions of cognitive-behavioral therapy for gambling disorder

CBT with VRETCBT with imaginal ET
virtual reality exposure therapy focus on gambling cuesOTHER

6 sessions of virtual reality exposure therapy focus on gambling cues

CBT with VRET

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU Amiens-Picardie

Amiens, France

NOT YET RECRUITING

CH Boulogne sur mer CSAPA

Boulogne-sur-Mer, France

NOT YET RECRUITING

CHU de Caen

Caen, France

NOT YET RECRUITING

Hôpital Fontan, CHU lille

Lille, 59000, France

NOT YET RECRUITING

Assoriation Cédragir Lomme CSAPA

Lomme, France

NOT YET RECRUITING

CH de l'arrondissement de Montreuil / CSAPA

Montreuil-sur-Mer, France

NOT YET RECRUITING

CHU Rouen

Rouen, France

NOT YET RECRUITING

CH de Saint Amand les Eaux

Saint-Amand-les-Eaux, France

NOT YET RECRUITING

CH Seclin Carvin CSAPA

Seclin, France

RECRUITING

Association GREID ValenciennesCSAPA

Valenciennes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Gambling

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Pierre TAQUET, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre TAQUET, PhD

CONTACT

0320445838pierre.taquet@chru-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 13, 2020

Study Start

July 12, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

May 14, 2026

Record last verified: 2026-05

Locations

FR(10)