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Trial record 10 of 37 for:    Recruiting, Not yet recruiting, Available Studies | "Conduct Disorder"

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

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ClinicalTrials.gov Identifier: NCT03673800
Recruitment Status : Not yet recruiting
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Collaborator:
ARJEL (Autorité de Régulation des Jeux En Ligne)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Pathological Gambling Other: Experimental Group Other: Control Group Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cognitive Control Training in Online Problem Gambling: an Online Randomized Controlled Trial Among Non-treatment Seeking Problem Gamblers
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Problem gambling severity index - recent (PGSI) [ Time Frame: Between baseline (T0) , and 14 weeks (T2) ]
  2. 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) ]
    Impulsivity scale

  3. Time Line Follow Back (TLFB) -gambling [ Time Frame: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2) ]
    Money and time spent gambling including offline gambling

  4. EuroQol five dimensions questionnaire (EQ-5D) [ Time Frame: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2) ]
    Health related quality of life self-questionnaire

  5. Gambling Quality of Life Scale (GQoLS) [ Time Frame: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2) ]
    Health related quality of life self-questionnaire specific to gambling disorder

  6. Neuropsychological assessment: Stop Signal Task (SST) [ Time Frame: Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2) ]
    Cognitive task assessing inhibition

  7. Total Deposit [ Time Frame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3) ]
    Total Deposit assessed by the account player based gambling data (ARJEL database)

  8. Total stake by game [ Time Frame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3) ]
    Total stake by game assessed by the account player based gambling data (ARJEL database)

  9. Compulsivity [ Time Frame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3) ]
    Compulsivity (as defined by three consecutive deposits in a 12-hour period of time) assessed by the account player based gambling data (ARJEL database)

  10. 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) ]
    Number of deposit in the hour following a stake assessed by the account player based gambling data (ARJEL database)

  11. Total loss by game [ Time Frame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3) ]
    Total loss by game assessed by the account player based gambling data (ARJEL database)

  12. Number of sessions (all games) [ Time Frame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3) ]
    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.

  13. Session duration (poker only) [ Time Frame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3) ]
    Session duration (poker only) assessed by the account player based gambling data (ARJEL database)

  14. Gambling time slot [ Time Frame: In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3) ]

    Gambling time slot assessed by the account player based gambling data (ARJEL database).

    The time slots are divided as follows:

    1. 0:00 to 3 :59
    2. 4:00 to 7:59
    3. 8:00 to 11:59
    4. 12:00 to 15:59
    5. 16:00 to 19:59
    6. 20:00 to 23:59

  15. Acceptability of the online program assessed by the number of training session [ Time Frame: At 6 week (T1) ]
  16. Acceptability of the online program assessed by the length of training session [ Time Frame: At 6 week (T1) ]
  17. Level of guidance assessed by the number of phone session [ Time Frame: At 6 week (T1) ]
    Number of debriefing by phone sessions

  18. Level of guidance assessed by the length of phone session [ Time Frame: At 6 week (T1) ]
    Length of debriefing by phone sessions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673800


Contacts
Contact: Amandine LUQUIENS, MD, PhD, HDR 33 (0)1 45 59 30 87 amandineluquiens@gmail.com

Locations
France
Paul Brousse Hospital
Villejuif, France, 94800
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
ARJEL (Autorité de Régulation des Jeux En Ligne)
Investigators
Principal Investigator: Amandine LUQUIENS, MD, PhD, HDR Assistance Publique Hoptiaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03673800     History of Changes
Other Study ID Numbers: P170601
2017-A01666-47 ( Other Identifier: IDRCB )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
gambling disorder
pathological gambling
problem gambling
addiction

Additional relevant MeSH terms:
Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders