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Virtual Reality Exposure Therapy for Gambling Disorder (VIRET-GAD)

Primary Purpose

Gambling Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cognitive-behavioral therapy for gambling disorder
imaginal exposure therapy focus on gambling cues
virtual reality exposure therapy focus on gambling cues
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gambling Disorder focused on measuring Exposure therapy, virtual reality, cognitive behavioral therapy, pathological gambling, CBT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens-Picardie
  • CH Boulogne sur mer CSAPA
  • CHU de Caen
  • Hôpital Fontan, CHU lille
  • Assoriation Cédragir Lomme CSAPA
  • CH de l'arrondissement de Montreuil / CSAPA
  • CHU Rouen
  • CH de Saint Amand les Eaux
  • CH Seclin Carvin CSAPA
  • Association GREID ValenciennesCSAPA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT with VRET

CBT with imaginal ET

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in South Oaks Gambling Screen (SOGS) between baseline and follow-up at 3, 6 and 12 months after the end of treatment
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.
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
Nine criteria for gambling disorder are described in DSM-5. The endorsement of 4-5 criteria means the presence of a mild gambling disorder, 6-7 criteria a moderate gambling disorder and 8-9 criteria a severe gambling disorder. The score ranges from 0 to 9 criteria.
Change in gambling disorder symptoms between baseline, end of treatment and follow-up assessed by the following criteria: Problem Gambling Severity Index (PGSI)
The PGSI consists of nine items to assess level of risk for problem gambling. Cut-off scores are 1-2 for low-risk gamblers, 3-7 for moderate-risk gamblers and 8 or more for problem-gamblers. Non-problem gamblers correspond to 0. The score ranges from 0 to 27.
Change in gambling behavior assessed by gambling frequency during the last month
Change in gambling behavior assessed by amount of money spent in gambling during the last month
Change in gambling behavior assessed by time spent gambling during the last month
Change in frequency subscale of gambling Craving Experience Questionnaire (g-CEQ)
The frequency subscale of gambling Craving Experience Questionnaire assesses the frequency of craving for gambling during the last week. This questionnaire consists of nine items. A high score means a high frequency of craving during the last week. The score ranges from 0 to 90.
Change in craving reactivity to gambling cues
Number of craving episodes using daily craving assessed by participants
Cumulative duration of craving episodes using daily craving assessed by participants
Change in gambling-related cognitions assessed by Gambling-Related Cognitions Scale (GRCS)
The French version of the Gambling-Related Cognitions Scale consists of 23 items to assess various cognitions related to gambling. A high score means that gambling-related cognitions are typical cognitions of problem gamblers. The score ranges from 23 to 161.
Change in depressive symptoms assessed by Beck Depression Inventory short-form (BDI-SF)
Beck Depression Inventory short-form consists of 13 items to assess depressive symptoms. A high score means a high level of depressive symptoms. The score ranges from 0 to 39.
Change in anxiety symptoms assessed by State-Trait Anxiety Inventory (STAI)
State-Trait Anxiety Inventory consists of 20 items to assess state-anxiety and 20 items to assess trait-anxiety. A high score means a high level of anxiety symptoms. The score ranges from 20 to 80 both for state-anxiety and trait-anxiety.
Rate of patients who attended the 12 sessions (6 months)
Quality of the two therapeutic strategies

Full Information

First Posted
June 29, 2020
Last Updated
May 17, 2022
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT04467502
Brief Title
Virtual Reality Exposure Therapy for Gambling Disorder
Acronym
VIRET-GAD
Official Title
Virtual Reality Exposure Therapy for Gambling Disorder: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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: 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. 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. 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. 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. Compare the quality of the two therapeutic strategies at the end of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling Disorder
Keywords
Exposure therapy, virtual reality, cognitive behavioral therapy, pathological gambling, CBT

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT with VRET
Arm Type
Experimental
Arm Title
CBT with imaginal ET
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
cognitive-behavioral therapy for gambling disorder
Intervention Description
6 sessions of cognitive-behavioral therapy for gambling disorder
Intervention Type
Other
Intervention Name(s)
imaginal exposure therapy focus on gambling cues
Intervention Description
6 sessions of imaginal exposure therapy focus on gambling cues
Intervention Type
Other
Intervention Name(s)
virtual reality exposure therapy focus on gambling cues
Intervention Description
6 sessions of virtual reality exposure therapy focus on gambling cues
Primary Outcome Measure Information:
Title
Change in South Oaks Gambling Screen (SOGS) between baseline and end of treatment (12 sessions, 6 months)
Description
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.
Time Frame
at the end of treatment (an average of 6 months)
Secondary Outcome Measure Information:
Title
Change in South Oaks Gambling Screen (SOGS) between baseline and follow-up at 3, 6 and 12 months after the end of treatment
Description
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.
Time Frame
at baseline, and through study completion, an average of 18 months
Title
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
Description
Nine criteria for gambling disorder are described in DSM-5. The endorsement of 4-5 criteria means the presence of a mild gambling disorder, 6-7 criteria a moderate gambling disorder and 8-9 criteria a severe gambling disorder. The score ranges from 0 to 9 criteria.
Time Frame
at baseline, and through study completion, an average of 18 months
Title
Change in gambling disorder symptoms between baseline, end of treatment and follow-up assessed by the following criteria: Problem Gambling Severity Index (PGSI)
Description
The PGSI consists of nine items to assess level of risk for problem gambling. Cut-off scores are 1-2 for low-risk gamblers, 3-7 for moderate-risk gamblers and 8 or more for problem-gamblers. Non-problem gamblers correspond to 0. The score ranges from 0 to 27.
Time Frame
at baseline, and through study completion, an average of 18 months
Title
Change in gambling behavior assessed by gambling frequency during the last month
Time Frame
at baseline, and through study completion, an average of 18 months
Title
Change in gambling behavior assessed by amount of money spent in gambling during the last month
Time Frame
at baseline, and through study completion, an average of 18 months
Title
Change in gambling behavior assessed by time spent gambling during the last month
Time Frame
at baseline, and through study completion, an average of 18 months
Title
Change in frequency subscale of gambling Craving Experience Questionnaire (g-CEQ)
Description
The frequency subscale of gambling Craving Experience Questionnaire assesses the frequency of craving for gambling during the last week. This questionnaire consists of nine items. A high score means a high frequency of craving during the last week. The score ranges from 0 to 90.
Time Frame
at baseline, and through study completion, an average of 18 months
Title
Change in craving reactivity to gambling cues
Time Frame
at baseline, and through study completion, an average of 18 months
Title
Number of craving episodes using daily craving assessed by participants
Time Frame
up to 6 months during the treatment
Title
Cumulative duration of craving episodes using daily craving assessed by participants
Time Frame
up to 6 months during the treatment
Title
Change in gambling-related cognitions assessed by Gambling-Related Cognitions Scale (GRCS)
Description
The French version of the Gambling-Related Cognitions Scale consists of 23 items to assess various cognitions related to gambling. A high score means that gambling-related cognitions are typical cognitions of problem gamblers. The score ranges from 23 to 161.
Time Frame
at baseline, and through study completion, an average of 18 months
Title
Change in depressive symptoms assessed by Beck Depression Inventory short-form (BDI-SF)
Description
Beck Depression Inventory short-form consists of 13 items to assess depressive symptoms. A high score means a high level of depressive symptoms. The score ranges from 0 to 39.
Time Frame
at baseline, and through study completion, an average of 18 months
Title
Change in anxiety symptoms assessed by State-Trait Anxiety Inventory (STAI)
Description
State-Trait Anxiety Inventory consists of 20 items to assess state-anxiety and 20 items to assess trait-anxiety. A high score means a high level of anxiety symptoms. The score ranges from 20 to 80 both for state-anxiety and trait-anxiety.
Time Frame
at baseline, and through study completion, an average of 18 months
Title
Rate of patients who attended the 12 sessions (6 months)
Description
Quality of the two therapeutic strategies
Time Frame
up to 6 months during the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre TAQUET, PhD
Phone
0320445838
Ext
+33
Email
pierre.taquet@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre TAQUET, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain DERVAUX, MD,PhD
Facility Name
CH Boulogne sur mer CSAPA
City
Boulogne-sur-Mer
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fréderic TEISSIERE, MD
Facility Name
CHU de Caen
City
Caen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas CABE, MD
Facility Name
Hôpital Fontan, CHU lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier COTTENCIN, MD,PhD
Facility Name
Assoriation Cédragir Lomme CSAPA
City
Lomme
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie Lienard
Facility Name
CH de l'arrondissement de Montreuil / CSAPA
City
Montreuil sur Mer
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu LAWNICZAK
Facility Name
CHU Rouen
City
Rouen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier GUILLIN, MD, PhD
Facility Name
CH de Saint Amand les Eaux
City
Saint-Amand-les-Eaux
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles LESCUT, MD
Facility Name
CH Seclin Carvin CSAPA
City
Seclin
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre TAQUET, PhD
Facility Name
Association GREID ValenciennesCSAPA
City
Valenciennes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ines Roux

12. IPD Sharing Statement

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Virtual Reality Exposure Therapy for Gambling Disorder

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