Cognitive Control Training in Online Problem Gambling (TRAIN-ONLINE)

Assistance Publique - Hôpitaux de Paris

Status: Active, not recruiting

Conditions: Pathological Gambling

Treatments: Other: Control Group; Other: Experimental Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03673800

P170601

2017-A01666-47 (Other Identifier)

Details and patient eligibility

About

An online single blinding, randomized, comparative therapeutic web-based, controlled trial. The main objective of the study is to assess the clinical efficacy of an online computerized cognitive training program targeted on cognitive control, namely on inhibition, measured with the PGSI-recent, a modified version of Problem Gambling Severity Index (PGSI) with a 30 days recall period in patients with problem gambling, at 6 weeks, as compared to a control program with a similar setting.

Full description

Cognitive training is currently used in brain damaged patients and in some psychiatric conditions, like schizophrenia or depression. Very few cognitive training programs have been published and tested in addictive disorders.

Training online is currently proposed in standard care, and is listed as recommended activities in daily hospitalization in addiction specialized out-settings in France.

The purpose of this research is to test the efficacy of an online intervention in gambling addiction through cognitive training targeting cognitive control inhibition.

The experimental Intervention (Cognitive Training) is a computerized cognitive training targeting inhibitory control of motor response (Scientific Brain Training®).The tasks included in the program have been selected and modified to target inhibition.

Control intervention is a sensorial program with a similar format targeting visual acuity. This is not a cognitive program, and can be considered as neutral in the addiction field.

An optional guidance by phone performed by a trained neuropsychologist is proposed to the included subjects in both groups, up to15 minutes twice a week.

Study design: A therapeutic web-based, comparative, randomized controlled trial, 2 arms, single blinding, with 52 weeks follow-up:

• a 14 weeks patient follow up (6 weeks for efficacy assessment and maintenance at 14 weeks).
• 52 weeks gambling account based data extracted from the ARJEL database in last 4 weeks before baseline, week 6, week 14 and week 52.

Population of study participants : Problem gamblers who will contact the responsible of the study.

Schedule for the study :

• Duration of inclusion period: 8 months
• Duration of patient participation: 52 weeks (12 months) including 14 weeks of active gambler participation and up to 52 weeks for the collection of gambler data from the ARJEL database.
• Total research duration: 20 months Main objective : To assess the clinical efficacy of an online computerized cognitive training program targeted on cognitive control, namely on inhibition, measured with the PGSI-recent, a modified version of Problem Gambling Severity Index (PGSI) with a 30 days recall period in patients with problem gambling, at 6 weeks.

Secondary objectives of the study are:

• to assess the efficacy on the evolution of the gambling behaviour assessed by the account player based gambling data, at 6, 14and 52 weeks.
• to assess the efficacy on the evolution of the self-reported gambling practice, and of quality of life at 0, 6 and 14 weeks.
• to assess the efficacy on the evolution of inhibition performance at the neuropsychological level at 0, 6 and 14, weeks.
• We will also assess the acceptability of this program and the preferred level of guidance of the non-treatment seeking problem gamblers as factor of response.

Statistical analysis:The change in PGSI-recent total score over 6 weeks will be compared with the student's t-test. If the test application conditions are not met, a Wilcoxon test will be applied.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Over 18 years old gamblers
2. Willing to share his/her first name, last name, exact birthdate, and exact place of birth (city + department). These informations are needed to extract ARJEL player account based gambling data, to avoid any doubloon or homonym.
3. PGSI-recent ≥ 5.
4. Recipient or beneficiary of the French social security system and resident in France.

Non-inclusion criteria

1. Gamblers cannot speak or understand French

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

Cognitive Training

Experimental group

Description:

Online Cognitive training on the Scientific Brain Training® (SBT®) platform with optional guidance by phone

Treatment:

Other: Experimental Group

Online sensorial program

Sham Comparator group

Description:

Online sensorial program on the Scientific Brain Training® (SBT®) platform with optional guidance by phone

Treatment:

Other: Control Group