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Pathological GamblingNCT04074681

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

A study testing Gambling Internet-based Protocol in people with Pathological Gambling, run by Universitat Jaume I.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. 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?
Gambling Internet-based Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
No sites listed yet
Study dates
1 Feb 2023to Dec 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

  • 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.

Who cannot join

  • 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.
  • Receiving pharmacological treatment is not an exclusion criterion during the study period, but participants having an increase and/or change in the medication 2 months prior to enrollment will not be considered for the trial. Also, the increase and/or change in the medication during the study period in the experimental group will imply the participant's exclusion from subsequent analyses (a decrease in pharmacological treatment is accepted).

Trial locations and contacts

No sites are listed yet.

Laura Díaz Sanahuja, PhDstudent contact

+34 964387651

lsanahuj@uji.es

Juana M Bretón López, Lecturer contact

+34 964387642

breton@uji.es

About this study

Official title: Efficacy of an Internet-based Psychological Intervention for Problem Gambling and Gambling Disorder: A Randomized Controlled Trial

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.

Read the detailed description

Gambling Disorder is a prevalent non-substance use disorder, which contrasts with the low number of people requesting treatment. Information and Communication Technologies (ICT) could help to enhance the dissemination of evidence-based treatments and considerably reduce the costs. The current study seeks to assess the efficacy of an online psychological intervention for people suffering from gambling problems in Spain. The proposed study will be a two-arm, parallel-group, randomized controlled trial. A total of 134 participants (problem and pathological gamblers) will be randomly allocated to a waiting list control group (N=67) or an intervention group (N=67). The intervention program includes 8 modules, and it is based on motivational interviewing, cognitive-behavioural therapy (CBT), and extensions and innovations of CBT. It includes several complementary tools that are present throughout the entire intervention. Therapeutic support will be provided once a week through a phone call with a maximum length of 10 minutes. The primary outcome measure will be gambling severity and gambling-related cognitions, and secondary outcome measures will be readiness to change, and gambling self-efficacy. Other variables that will be considered are depression and anxiety symptoms, positive and negative affect, difficulties in emotion regulation strategies, impulsivity, and quality of life. Individuals will be assessed at baseline, post-treatment, and 3-, 6-, and 12-month follow-ups. During the treatment, participants will also respond to a daily Ecological Momentary Intervention (EMI) in order to evaluate urges to gamble, self-efficacy to cope with gambling urges, gambling urge frequency, and whether gambling behaviour occurs. The EMI includes immediate automatic feedback depending on the participant's responses. Treatment acceptance and satisfaction will also be assessed. The data will be analysed both per protocol and by Intention-to-treat. As far as we know, this is the first randomized controlled trial of an online psychological intervention for gambling disorder in Spain. It will expand our knowledge about treatments delivered via the Internet and contribute to improving treatment dissemination, reaching people suffering from this problem who otherwise would not receive help.

Being tested
Gambling Internet-based Protocol
Keywords
Gambling, CBT, Internet program, Efficacy
Medical subject headings
Gambling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gambling Internet-based ProtocolBehavioural

    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.

Study groups in NCT04074681
Study groupRoleWhat they receive
Gambling Internet-based ProtocolExperimentalIntervention 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.
Receives: Behavioral: Gambling Internet-based Protocol
Waiting List Control GroupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 12 months

  2. 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).

    Measured: Up to 12 months

Secondary outcomes (3)

  1. 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.

    The GSEQ is a self-report instrument that assesses perceived self-efficacy to control gambling in high-risk situations through 16 six-point Likert scale items. Participants are asked to indicate how confident they feel in a scale that ranges from 0% (Not at all confident) to 100% (Very confident) in increments of 20%. Specifically, it includes intrapersonal (e.g. unpleasant emotions, physical discomfort, pleasant emotions, testing personal control, and urges and temptations) and interpersonal factors (conflict with others, social pressure and pleasant times with others) based on Marlatt's (1985) model of relapse situations for addictive behaviors. The overall score is calculated taking into account the mean response from all items, and it can range from 0 to 100. The higher overall score the higher overall confidence about controlling their gambling behavior. There is evidence of convergent and discriminant validity, and the internal consistency is high (α=0.99) in a community sample.

    Measured: Up to 12 months

  2. 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.

    The URICA is a 32 items self-report instrument that includes four subscales and assesses four of the five stages of change proposed by Prochaska \& DiClemente (precontemplation, PC; contemplation, C; action, A; and maintenance, M) on a 5-point Likert type scale (1=strongly disagree; 5=strongly agree). Scores for each subscale range from 8 to 40, and are obtained adding the value of the 5 items that include each subscale. A second-order score is obtained and is referred to the degree of 'Readiness to change' (C+A+M-PC). The URICA shows good psychometric proprieties in a sample of pathological gamblers. The internal consistency values are adequate for the stages of change assessed as well as for the total score corresponding to 'Readiness to change'. Specifically, the Cronbach's alpha coefficients ranges from 0.74 to 0.84 taking into account the different stages (Precontemplation=0.74; Contemplation=0.80; Action=0.84; and Maintenance=0.74) and for the total score is 0.84.

    Measured: Up to 12 months

  3. Change in the EMI measures during procedure.

    Gambling urge intensity (on a scale from 0 "Not at all" to 10 "maximum") and frequency (on a 5-point Likert scale from "Never" to "Almost always"), self-efficacy to cope with gambling urges (on a scale from 0 "Not at all" to 10 "Completely"), gambling behaviour (yes/no), money wagered (euros), and amount of time gambling (minutes) are also assessed for 90 days in the experimental group.

    Measured: During procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2019
  2. Study start1 Feb 2023 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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
None (open label)
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04074681
Sponsor's protocol ID
UJI-A2016-14
Status last verified
May 2022
First submitted
22 Jul 2019
Last updated
24 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30138469

  • 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.

    PubMed 19045977

  • 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.

    PubMed 30701377

  • 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.

    PubMed 28662618

  • 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.

    PubMed 34646753

Questions about this trial

What is this clinical trial studying?

A study testing Gambling Internet-based Protocol in people with Pathological Gambling, run by Universitat Jaume I.

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 7 inclusion and 5 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 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Contact Laura Díaz Sanahuja, PhDstudent (+34 964387651, lsanahuj@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Up to 12 months). The study lists 2 primary outcomes in all. 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 NCT04074681, which also lists 5 linked publications.

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 24 May 2022.

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