Clinical trial NCT03673800: Cognitive Control Training in Online Problem Gambling
Official title: Cognitive Control Training in Online Problem Gambling: an Online Randomized Controlled Trial Among Non-treatment Seeking Problem Gamblers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pathological Gambling
Keywords: gambling disorder
pathological gambling
problem gambling
addiction
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: ARJEL (Autorité de Régulation des Jeux En Ligne)
First posted: 2018-09-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: The change over 6 weeks in Problem gambling severity index (PGSI)-recent total score, collected by internet
timeFrame: Change from baseline at 6 weeks
Secondary outcomes:
measure: Problem gambling severity index - recent (PGSI)
timeFrame: Between baseline (T0) , and 14 weeks (T2)
measure: Short form of Urgency, Premeditation, Perseverance, Sensation seeking, and Positive urgency (UPPS-P) Impulsive behavior scale
timeFrame: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
measure: Time Line Follow Back (TLFB) -gambling
timeFrame: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
measure: EuroQol five dimensions questionnaire (EQ-5D)
timeFrame: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
measure: Gambling Quality of Life Scale (GQoLS)
timeFrame: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
measure: Neuropsychological assessment: Stop Signal Task (SST)
timeFrame: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
measure: Total Deposit
timeFrame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
measure: Total stake by game
timeFrame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
measure: Compulsivity
timeFrame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
measure: Number of deposit in the hour following a stake
timeFrame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
measure: Total loss by game
timeFrame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
measure: Number of sessions (all games)
timeFrame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
measure: Session duration (poker only)
timeFrame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
measure: Gambling time slot
timeFrame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
measure: Acceptability of the online program assessed by the number of training session
timeFrame: At 6 week (T1)
measure: Acceptability of the online program assessed by the length of training session
timeFrame: At 6 week (T1)
measure: Level of guidance assessed by the number of phone session
timeFrame: At 6 week (T1)
measure: Level of guidance assessed by the length of phone session
timeFrame: At 6 week (T1)
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Paul Brousse Hospital
Study officials:
affiliation: Assistance Publique Hoptiaux de Paris
name: Amandine LUQUIENS, MD, PhD, HDR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santiago A, Carre A, Miranda R, Lemogne C, LeStrat Y, Benyamina A, Perney P, Luquiens A. Study protocol for an online randomised controlled trial among non-treatment seeking problem gamblers: training inhibition in online problem gambling (TRAIN-online) trial. BMJ Open. 2021 Nov 30;11(11):e051641. doi: 10.1136/bmjopen-2021-051641.