Pathological GamblingTRAIN-ONLINENCT03673800
Cognitive Control Training in Online Problem Gambling
A study testing Experimental Group in people with Pathological Gambling, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2019to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old gamblers
- 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.
- PGSI-recent ≥ 5.
- Recipient or beneficiary of the French social security system and resident in France.
- Non-inclusion criteria
- 1. Gamblers cannot speak or understand French
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pathological Gambling
- Being tested
- Experimental Group, Control Group
- Keywords
- gambling disorder, pathological gambling, problem gambling, addiction
- Medical subject headings
- Gambling, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
Also called Cognitive training with optional guidance by phone
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 GroupOther
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
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Online Cognitive training on the Scientific Brain Training® (SBT®) platform with optional guidance by phone Receives: Other: Experimental Group |
| Online sensorial program | Sham comparator | Online sensorial program on the Scientific Brain Training® (SBT®) platform with optional guidance by phone Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline at 6 weeks
Secondary outcomes (18)
Problem gambling severity index - recent (PGSI)
Measured: 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
Measured: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
Time Line Follow Back (TLFB) -gambling
Money and time spent gambling including offline gambling
Measured: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
EuroQol five dimensions questionnaire (EQ-5D)
Health related quality of life self-questionnaire
Measured: 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
Measured: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
Neuropsychological assessment: Stop Signal Task (SST)
Cognitive task assessing inhibition
Measured: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
Total Deposit
Total Deposit assessed by the account player based gambling data (ARJEL database)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: At 6 week (T1)
Acceptability of the online program assessed by the length of training session
Measured: At 6 week (T1)
Level of guidance assessed by the number of phone session
Number of debriefing by phone sessions
Measured: At 6 week (T1)
Level of guidance assessed by the length of phone session
Length of debriefing by phone sessions
Measured: At 6 week (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start18 Feb 2019
- Primary completion6 Jun 2023
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pathological GamblingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- ARJEL (Autorité de Régulation des Jeux En Ligne)
- Responsible party
- Sponsor
- Investigators
- Amandine LUQUIENS, MD, PhD, HDR, Principal investigator, Assistance Publique Hoptiaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673800
- Sponsor's protocol ID
- P170601
- Other IDs
- 2017-A01666-47
- Acronym
- TRAIN-ONLINE
- Status last verified
- Feb 2024
- First submitted
- 27 Aug 2018
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34848517
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Control Training in Online Problem Gambling: an Online Randomized Controlled Trial Among Non-treatment Seeking Problem Gamblers
- ClinicalTrials.gov ID
- NCT03673800
- Acronym / sponsor ID
- TRAIN-ONLINE / P170601
- Conditions
- Pathological Gambling
- Keywords
- gambling disorder, pathological gambling, problem gambling, addiction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- ARJEL (Autorité de Régulation des Jeux En Ligne)
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- Mar 2024 (estimated)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Other: Experimental GroupOnline Cognitive training on the Scientific Brain Training® (SBT®) platform with optional guidance by phone |
| Online sensorial program | Sham comparator | Other: Control GroupOnline sensorial program on the Scientific Brain Training® (SBT®) platform with optional guidance by phone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years old gamblers
- 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.
- PGSI-recent ≥ 5.
- Recipient or beneficiary of the French social security system and resident in France.
- Non-inclusion criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupAlso: Cognitive training with optional guidance by phoneCognitive 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 | Cognitive Training |
| Control GroupSensorial 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 | Online sensorial program |
Primary outcome
The change over 6 weeks in Problem gambling severity index (PGSI)-recent total score, collected by internet
Time frame: Change from baseline at 6 weeks
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
18 secondary outcomes
Problem gambling severity index - recent (PGSI)
Time frame: Between baseline (T0) , and 14 weeks (T2)
Short form of Urgency, Premeditation, Perseverance, Sensation seeking, and Positive urgency (UPPS-P) Impulsive behavior scale
Time frame: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
Time Line Follow Back (TLFB) -gambling
Time frame: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
EuroQol five dimensions questionnaire (EQ-5D)
Time frame: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
Gambling Quality of Life Scale (GQoLS)
Time frame: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
Neuropsychological assessment: Stop Signal Task (SST)
Time frame: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)
Total Deposit
Time frame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
Total stake by game
Time frame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
Compulsivity
Time frame: 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
Time frame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
Total loss by game
Time frame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
Number of sessions (all games)
Time frame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
Session duration (poker only)
Time frame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3)
Gambling time slot
Time frame: 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
Time frame: At 6 week (T1)
Acceptability of the online program assessed by the length of training session
Time frame: At 6 week (T1)
Level of guidance assessed by the number of phone session
Time frame: At 6 week (T1)
Level of guidance assessed by the length of phone session
Time frame: At 6 week (T1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Derived from this study: PubMed 34848517Santiago 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amandine LUQUIENS, MD, PhD, HDR principal investigator
Assistance Publique Hoptiaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Pathological Gambling, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change over 6 weeks in Problem gambling severity index (PGSI)-recent total score, collected by internet (time frame: Change from baseline at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03673800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.