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

Cognitive Control Training in Online Problem Gambling: an Online Randomized Controlled Trial Among Non-treatment Seeking Problem Gamblers

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pathological Gambling
• Intervention / Treatment: Other: Experimental Group; Other: Control Group

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amandine LUQUIENS, MD, PhD, HDR; Phone Number: 33 (0)1 45 59 30 87; Email: amandineluquiens@gmail.com

Study Locations

• France
  • Villejuif, France, 94800
    • Paul Brousse Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Training; Online Cognitive training on the Scientific Brain Training® (SBT®) platform with optional guidance by phone	Other: Experimental Group; Cognitive web-based training : 2 up to 30 minutes sessions a week during 6 weeks. Optional debriefing by a neuropsychologist up to 15 minutes twice a week; Other Names: Cognitive training with optional guidance by phone
Sham Comparator: Online sensorial program; Online sensorial program on the Scientific Brain Training® (SBT®) platform with optional guidance by phone	Other: Control Group; Sensorial web-based training : 2 up to 30 minutes sessions a week during 6 weeks. Optional debriefing by a neuropsychologist up to 15 minutes twice a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change over 6 weeks in Problem gambling severity index (PGSI)-recent total score, collected by internet	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	Change from baseline at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Problem gambling severity index - recent (PGSI)		Between baseline (T0) , and 14 weeks (T2)
Short form of Urgency, Premeditation, Perseverance, Sensation seeking, and Positive urgency (UPPS-P) Impulsive behavior scale	Impulsivity scale	Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
Time Line Follow Back (TLFB) -gambling	Money and time spent gambling including offline gambling	Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
EuroQol five dimensions questionnaire (EQ-5D)	Health related quality of life self-questionnaire	Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
Gambling Quality of Life Scale (GQoLS)	Health related quality of life self-questionnaire specific to gambling disorder	Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
Neuropsychological assessment: Stop Signal Task (SST)	Cognitive task assessing inhibition	Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
Total Deposit	Total Deposit assessed by the account player based gambling data (ARJEL database)	In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
Total stake by game	Total stake by game assessed by the account player based gambling data (ARJEL database)	In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
Compulsivity	Compulsivity (as defined by three consecutive deposits in a 12-hour period of time) assessed by the account player based gambling data (ARJEL database)	In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
Number of deposit in the hour following a stake	Number of deposit in the hour following a stake assessed by the account player based gambling data (ARJEL database)	In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
Total loss by game	Total loss by game assessed by the account player based gambling data (ARJEL database)	In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
Number of sessions (all games)	Number of sessions (all games) in a clinical meaning assessed by the account player based gambling data (ARJEL database) Session is defined as gambling behaviour in itself; we'll consider the beginning of a session when a gambling action occurs after no gambling action since at least 30 minutes, and the end of the gambling session a gambling action followed by no gambling action during 30 minutes.	In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
Session duration (poker only)	Session duration (poker only) assessed by the account player based gambling data (ARJEL database)	In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
Gambling time slot	Gambling time slot assessed by the account player based gambling data (ARJEL database). The time slots are divided as follows: 0:00 to 3 :59; 4:00 to 7:59; 8:00 to 11:59; 12:00 to 15:59; 16:00 to 19:59; 20:00 to 23:59	In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
Acceptability of the online program assessed by the number of training session		At 6 week (T1)
Acceptability of the online program assessed by the length of training session		At 6 week (T1)
Level of guidance assessed by the number of phone session	Number of debriefing by phone sessions	At 6 week (T1)
Level of guidance assessed by the length of phone session	Length of debriefing by phone sessions	At 6 week (T1)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: ARJEL (Autorité de Régulation des Jeux En Ligne)
• Investigators: Principal Investigator: Amandine LUQUIENS, MD, PhD, HDR, Assistance Publique Hoptiaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2019
• Primary Completion (Actual): June 6, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: addiction; pathological gambling; problem gambling; gambling disorder
• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Gambling
• Other Study ID Numbers: P170601; 2017-A01666-47 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No