Clinical trial NCT04074681: Efficacy of an Internet-based Psychological Intervention for Problem Gambling and Gambling Disorder
Official title: Efficacy of an Internet-based Psychological Intervention for Problem Gambling and Gambling Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pathological Gambling
Keywords: Gambling
CBT
Internet program
Efficacy
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
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.
timeFrame: Up to 12 months
measure: 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.
timeFrame: Up to 12 months
Secondary outcomes:
measure: 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.
timeFrame: Up to 12 months
measure: 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.
timeFrame: Up to 12 months
measure: Change in the EMI measures during procedure.
timeFrame: During procedure.
Other outcomes:
measure: 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.
timeFrame: Up to 12 months
measure: Mini International Neuropsychiatric Interview - The M.I.N.I. 7.0.2, 8/8/16 version (Sheehan, 2016).
timeFrame: Pre-intervention (screening)
measure: Gambling history interview and current gambling situation and related variables assessment at the pre-intervention (screening)
timeFrame: Pre-intervention (screening)
measure: Change in the Hospital Anxiety Depression Scale (HADS) (Zigmond and Snaith, 1983; Castresana et al., 1995) at Pre-intervention, Post-intervention, 3-, 6-, and 12 months Follow-up.
timeFrame: Up to 12 months
measure: Change in the Overall Depression Severity and Impairment Scale (ODSIS; Bentley, Gallagher, Carl & Barlow, 2014; Spanish validation Mira et al., 2019) at Post-module.
timeFrame: During procedure.
measure: Change in the Overall Anxiety Severity and Impairment Scale (OASIS; Campbell-Sills et al., 2009; Spanish validation González-Robles et al., 2018) at Post-module.
timeFrame: During procedure.
measure: Change in the Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004: Spanish validation Hervás & Jódar, 2008) at Pre-intervention, Post-intervention, 3-, 6-, and 12 months Follow-up.
timeFrame: Up to 12 months
measure: Change in the Positive and Negative Affect Schedule (PANAS; Watson, Clark & Tellegen, 1988) at Pre-intervention, Post-intervention, 3-, 6-, and 12 months Follow-up.
timeFrame: Up to 12 months
measure: Change in the Short UPPS-P Impulsivity Scale (UPPS-P; Lynam, Smith, Whiteside & Cyders, 2006; Spanish validation Cándido, Orduña, Perales, Verdejo-García & Billieux, 2012) at Pre-intervention, Post-intervention, 3-, 6-, and 12 months Follow-up.
timeFrame: Up to 12 months
measure: Change in the Quality Life Index (QLI; Mezzich, Cohen & Ruipérez, 1999; Spanish validation Mezzich, Ruipérez, Pérez, Yoon, Liu & Mahmud, 2000) at Pre-intervention, Post-intervention, 3- , 6-, and 12 months Follow-up.
timeFrame: Up to 12 months
measure: Change in the System Usability Scale (SUS; Castilla et al., 2016) after the first use of the program (after the welcome module) and post-intervention.
timeFrame: Up to 3 months
Locations:
Study officials:
affiliation: Universitat Jaume I
name: Juana M Bretón López, Lecturer
role: STUDY_DIRECTOR
affiliation: Universitat Jaume I
name: Azucena García Palacios, Lecturer
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.