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

U

University Hospital, Lille

Status

Not yet enrolling

Conditions

Gambling Disorder

Treatments

Other: imaginal exposure therapy focus on gambling cues
Other: cognitive-behavioral therapy for gambling disorder
Other: virtual reality exposure therapy focus on gambling cues

Study type

Interventional

Funder types

Other

Identifiers

NCT04467502
2020_02
2020-A02710-39 (Other Identifier)

Details and patient eligibility

About

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.

Full 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:

  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.

Enrollment

124 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

124 participants in 2 patient groups

CBT with VRET
Experimental group
Treatment:
Other: virtual reality exposure therapy focus on gambling cues
Other: cognitive-behavioral therapy for gambling disorder
CBT with imaginal ET
Active Comparator group
Treatment:
Other: cognitive-behavioral therapy for gambling disorder
Other: imaginal exposure therapy focus on gambling cues

Trial contacts and locations

10

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Central trial contact

Pierre TAQUET, PhD

Data sourced from clinicaltrials.gov

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