Cognitive Control Training in Online Problem Gambling

Pathological Gambling Clinical Trial

— TRAIN-ONLINE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03673800
• Other study ID #: P170601
• Secondary ID: 2017-A01666-47
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 18, 2019
• Est. completion date: March 2024

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 2024
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gambling
• Pathological Gambling

Intervention

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
• 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

Locations

Country	Name	City	State
France	Paul Brousse Hospital	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	ARJEL (Autorité de Régulation des Jeux En Ligne)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Problem gambling severity index - recent (PGSI)		Between baseline (T0) , and 14 weeks (T2)
Secondary	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)
Secondary	Time Line Follow Back (TLFB) -gambling	Money and time spent gambling including offline gambling	Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
Secondary	EuroQol five dimensions questionnaire (EQ-5D)	Health related quality of life self-questionnaire	Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
Secondary	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)
Secondary	Neuropsychological assessment: Stop Signal Task (SST)	Cognitive task assessing inhibition	Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Acceptability of the online program assessed by the number of training session		At 6 week (T1)
Secondary	Acceptability of the online program assessed by the length of training session		At 6 week (T1)
Secondary	Level of guidance assessed by the number of phone session	Number of debriefing by phone sessions	At 6 week (T1)
Secondary	Level of guidance assessed by the length of phone session	Length of debriefing by phone sessions	At 6 week (T1)