NCT03673800

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 18, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

4.3 years

First QC Date

August 27, 2018

Last Update Submit

February 14, 2024

Conditions

Pathological Gambling

Keywords

gambling disorderpathological gamblingproblem gamblingaddiction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • 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

    Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)

  • Time Line Follow Back (TLFB) -gambling

    Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)

  • EuroQol five dimensions questionnaire (EQ-5D)

    Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)

  • Gambling Quality of Life Scale (GQoLS)

    Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2)

  • +13 more secondary outcomes

Study Arms (2)

Cognitive Training

EXPERIMENTAL

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

Other: Experimental Group

Online sensorial program

SHAM COMPARATOR

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

Other: Control Group

Interventions

Experimental GroupOTHER

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

Also known as: Cognitive training with optional guidance by phone
Cognitive Training
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

Online sensorial program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • \. Gamblers cannot speak or understand French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paul Brousse Hospital

Villejuif, 94800, France

Location

Related Publications (1)

  • 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.

    PMID: 34848517DERIVED

MeSH Terms

Conditions

GamblingBehavior, Addictive

Interventions

Cognitive TrainingControl Groups

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental DisordersCompulsive BehaviorImpulsive Behavior

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Amandine LUQUIENS, MD, PhD, HDR

    Assistance Publique Hoptiaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2018

First Posted

September 17, 2018

Study Start

February 18, 2019

Primary Completion

June 6, 2023

Study Completion

March 1, 2024

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations

FR(1)