Efficacy of an Internet-based Psychological Intervention for Problem Gambling and Gambling Disorder

NCT04074681 | Unknown DMC

• 1 other identifier: UJI-A2016-14
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to assess the efficacy of an online CBT-based intervention combined with an Ecological Momentary Intervention (EMI) and different complementary tools for the treatment of problem gambling and gambling disorder. The main hypothesis is that the Internet-based psychological intervention group will obtain better results than the waiting list control group.

Conditions

Pathological Gambling

Keywords

Gambling; CBT; Internet program; Efficacy

Outcome Measures

Primary Outcomes (2)

• Change in the Gambling Symptom Assessment Scale (G-SAS; Kim, Grant, Potenza, Blanco & Hollander, 2009) at Pre-intervention, Post-module, Post-intervention, 3-, 6-, and 12 months Follow-up.

  The G-SAS is a 12-item self-report instrument that assesses gambling symptom severity. All items are referred to as an average symptom based on the past 7 days.The statements correspond with gambling urges;average frequency, duration,and control of thoughts associated with gambling;time spent on gambling or gambling-related behaviour;anticipatory excitement caused by an imminent gambling act; pleasure associated with winning;emotional distress;and personal trouble.All items are rated on a 4-point scale (total score: 0-48).The higher score the higher gambling symptoms severity (mild=8-20;moderate=21-30;severe=31-40;extreme=41-48).It shows high internal consistency (α=0.87) and good convergent validity with other measures associated with gambling symptom severity in a sample of pathological gamblers.Because this instrument has not a Spanish version, standardized procedures were followed to adapt G-SAS to the Spanish language.Cronbach's alpha will be calculated with the data at hand.

  Up to 12 months

• Change in the Gambling-Related Cognitions Scale (GRCS-S; Raylu & Oei, 2004; Spanish validation Del Prete, Steward, Navas, Fernández-Aranda, Jiménez-Murcia, Oei & Perales, 2016) at Pre-intervention, Post-intervention, 3-, 6-, and 12 months Follow-up.

  The GRCS-S is a self-report instrument aimed to assess five domains of gambling-related cognitions (interpretative bias, IB; the illusion of control, IC; predictive control, PC; gambling expectancies, GE; and perceived inability to stop gambling, ISG). It comprises 23 items which are worded on a 7-point Likert type scale (1= I completely disagree; 7=I completely agree). The total score consists of adding the values of the whole items. The score for each subscale is obtained adding the values for the items' set that represent each subscale. The higher the total score the higher the number of gambling-related cognitions presented. GRCS-S shows adequate psychometric properties in a sample composed by treatment-seeking gamblers and non-treatment-seeking gamblers: the concurrent and criterion-related validity are verified, the full scale reliability is 0.95, and for each subscale reliability ranges from 0.68 to 0.91 (GE= 0.77; IC=0.68; PC=0.84; ISG=0.91; IB= 0.89).

  Up to 12 months

Secondary Outcomes (3)

• Change in the Gambling Self-Efficacy Questionnaire (GSEQ; May, Whelan, Steenbergh & Meyers, 2003; Winfree, Ginley, Whelan, & Meyers, 2014) at Pre-intervention, Post-module, Post-intervention, 3-, 6-, and 12 months Follow-up.

  Up to 12 months

• Change in the University of Rhode Island Change Assessment Scale (URICA; McConnaughy, Prochaska & Velicer, 1983; Spanish validation Gómez-Peña et al., 2011) at Pre-intervention, Post-intervention, 3-, 6-, and 12 months Follow-up.

  Up to 12 months

• Change in the EMI measures during procedure.

  During procedure.

Other Outcomes (11)

• Change in the NORC DSM-IV Screen for Gambling Problems (NODS; Gernstein et al., 1999; Becoña, 2004) at Pre-intervention (screening), Post-intervention, 3-, 6- and 12 months Follow-up.

  Up to 12 months

• Mini International Neuropsychiatric Interview - The M.I.N.I. 7.0.2, 8/8/16 version (Sheehan, 2016).

  Pre-intervention (screening)

• Gambling history interview and current gambling situation and related variables assessment at the pre-intervention (screening)

  Pre-intervention (screening)

Study Arms (2)

Gambling Internet-based Protocol

EXPERIMENTAL

Intervention group that carries out the Gambling Internet-based Protocol based on Cognitive and Behavioral Therapy (CBT) and receives support by the therapist (a weekly 10-minute phone call without clinical content). In addition, they will receive one notification per day to respond to the EMI questions at 8 PM. The EMI includes immediate automatic feedback depending on the participant's responses.

Behavioral: Gambling Internet-based Protocol

Waiting List Control Group

NO INTERVENTION

Participants in a 12-week waiting list control condition. They will be offered the possibility of receiving the online treatment protocol after the waiting list period.

Interventions

Gambling Internet-based Protocol BEHAVIORAL

Gambling Internet-based protocol is a multimedia interactive and self-help program for problem and pathological gamblers, which will allow individuals to learn and practice adaptive ways to cope with this problem. The main therapeutic modules included in this program are: 1) Motivational for change; 2) Psychoeducation; 3) Stimulus control (e.g. self-prohibition and blocking of usual gambling websites with therapist confirmation) and responsible return of debts; 4) Cognitive restructuring; 5) Emotion regulation; 6) Planning of significant activities; 7) Coping skills and exposure with response prevention; 8) Relapse prevention.

Gambling Internet-based Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years or older.
• Willingness to participate in the study and sign informed consent.
• To have and handle the computer, Internet and an email address.
• Ability to understand, read and write Spanish.
• Based on the cut-off points established by the Norc diagnostic screen for gambling disorders (NODS; adapted by Becoña, 2004): be a problem gambler (3-4 items) or a pathological gambler (5 or more items).
• Willingness to provide the name of a co-therapist to validate the information provided, as well as to be able to locate the patient in follow-ups.
• Willing to provide follow-up data on gambling.

You may not qualify if:

• Any serious mental disorder (Bipolar and Related Disorders and Schizophrenia Spectrum and Other Psychotic Disorders), medical illness, and moderate or severe alcohol and/or substance use disorder, that prevents the program from being carried out.
• If their gambling behaviour occurs in the context of a Maniac Episode or because of the intake of dopaminergic medication (e.g. Parkinson's disease).
• The presence of high suicidal risk.
• Receiving another psychological treatment while the study is still ongoing.

Sponsors & Collaborators

• Universitat Jaume I: lead

Related Publications (5)

• Bucker L, Bierbrodt J, Hand I, Wittekind C, Moritz S. Correction: Effects of a depression-focused internet intervention in slot machine gamblers: A randomized controlled trial. PLoS One. 2018 Aug 23;13(8):e0203145. doi: 10.1371/journal.pone.0203145. eCollection 2018.

  PMID: 30138469 BACKGROUND

• Carlbring P, Smit F. Randomized trial of internet-delivered self-help with telephone support for pathological gamblers. J Consult Clin Psychol. 2008 Dec;76(6):1090-4. doi: 10.1037/a0013603.

  PMID: 19045977 BACKGROUND

• Hodgins DC, Cunningham JA, Murray R, Hagopian S. Online Self-Directed Interventions for Gambling Disorder: Randomized Controlled Trial. J Gambl Stud. 2019 Jun;35(2):635-651. doi: 10.1007/s10899-019-09830-7.

  PMID: 30701377 BACKGROUND

• Goslar M, Leibetseder M, Muench HM, Hofmann SG, Laireiter AR. Efficacy of face-to-face versus self-guided treatments for disordered gambling: A meta-analysis. J Behav Addict. 2017 Jun 1;6(2):142-162. doi: 10.1556/2006.6.2017.034.

  PMID: 28662618 BACKGROUND

• Diaz-Sanahuja L, Campos D, Mira A, Castilla D, Garcia-Palacios A, Breton-Lopez JM. Efficacy of an internet-based psychological intervention for problem gambling and gambling disorder: Study protocol for a randomized controlled trial. Internet Interv. 2021 Oct 5;26:100466. doi: 10.1016/j.invent.2021.100466. eCollection 2021 Dec.

  PMID: 34646753 DERIVED

Related Links

• Laboratory of Psychology and Technology of the Jaume I University

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Study Officials

• Juana M Bretón López, Lecturer

  Universitat Jaume I

  STUDY DIRECTOR

• Azucena García Palacios, Lecturer

  Universitat Jaume I

  STUDY DIRECTOR

Central Study Contacts

Laura Díaz Sanahuja, PhDstudent

CONTACT

+34 964387651; lsanahuj@uji.es

Juana M Bretón López, Lecturer

CONTACT

+34 964387642; breton@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 30, 2019
• Study Start: February 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 24, 2022

Record last verified: 2022-05