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Efficacy of an Internet-based Psychological Intervention for Gambling Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074681
Recruitment Status : Not yet recruiting
First Posted : August 30, 2019
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Universitat Jaume I

Brief Summary:
The aim of this study is to assess the efficacy of an online CBT-based intervention for the treatment of gambling disorder. The main hypothesis is that the Internet-based psychological intervention group will obtain better results than the waiting list control group.

Condition or disease Intervention/treatment Phase
Pathological Gambling Behavioral: Gambling Internet-based Protocol Not Applicable

Detailed Description:
Gambling disorder (GD) is a non-substance-related disorder with a high prevalence, which ranges from 0.12% to 5.8% (Calado & Griffiths, 2016). It contrasts with the small number of people requesting treatment. Information and Communication Technologies (ICT) could help to enhance the dissemination of evidence-based treatments as well as considerably reduce costs. The first-line treatment for GD is Cognitive-Behavioral Therapy (CBT) and there are programs based on this approach applied by ICT that have shown its efficacy in other countries (Bücker et al., 2018; Carlbring & Smith, 2008; Hodgins et al., 2019). Nevertheless, as far as the investigators concern in Spain there is not any program with these characteristics. The main objective of this study is to assess the efficacy of an online CBT-based intervention for the treatment of gambling disorders. The study will be a 2-arm, parallel-group, randomized controlled trial. A total of 134 participants (risk, 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 consists of 8 modules and, although it is recommended to perform a module per week, participants can realize it over 12 weeks. Individuals in the intervention condition will also receive weekly telephone support (15 minutes) and will respond to a daily Ecological Momentary Assessment (EMA) that immediately offers positive feedback in the case that participants do not gamble, and inform about the number of days without betting. On the contrary, if they bet, EMA sends an alert to the therapist, who can make a phone call to support the participant. Assessments will be conducted at pre-intervention, post-intervention, and at 3-, 6-, and 12-month follow-up. The primary outcome is gambling severity using the Norc diagnostic screen for gambling disorders (NODS; adapted by Becoña, 2004). Secondary outcomes include the urge to gamble, self-efficacy, cognitive distortions and stages of change. Other outcomes are impulsivity, emotion regulation, positive and negative affect, depression, anxiety, and quality of life. The main hypothesis is that the Internet-based psychological intervention group will obtain better results than the waiting list control group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of an Internet-based Psychological Intervention for Gambling Disorder: A Randomized Controlled Trial
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gambling Internet-based Protocol
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 15-minute phone call without clinical content and a daily feedback message using Ecological Momentary Assessment, EMA).
Behavioral: Gambling Internet-based Protocol
Gambling Internet-based protocol is a multimedia interactive and self-help program for risk, 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.

No Intervention: Waiting List Control Group
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.



Primary Outcome Measures :
  1. Change in the NORC DSM-IV Screen for Gambling Problems (NODS; Gernstein et al., 1999; Becoña, 2004) at Pre-intervention, Post-intervention, 3-, 6- and 12 months Follow-up. [ Time Frame: Up to 12 months ]
    The NODS is a hierarchically structured 17-item screen that is designed to assess the at-risk, problem and pathological gambling. It is referred to the experience in gambling both throughout their life and in the last year, with dichotomous choice questions (Yes / No). The total score ranges from 0 to 10 (1-2 affirmative items correspond with at-risk gambling; 3-4 items with problem gambling; and 6 or more with pathological gambling). The data obtained on specificity and sensitivity is good, its test-retest reliability is 0.98, and its validity is excellent considering that it corresponds strictly to the DSM-IV criteria.


Secondary Outcome Measures :
  1. Change in the Problem Gambling Severity Index (PGSI; Ferris & Wynne, 2001; Spanish validation López-González, Estévez & Griffiths, 2018) at Pre-intervention, Post-intervention, 3-, 6-, and 12 months Follow-up. [ Time Frame: Up to 12 months ]
    The PGSI is a 9-item self-report instrument that was designed to assess gambling severity (4 items evaluate problem gambling behaviours and 5 items adverse consequences of gambling) on a 4-point Likert scale (0=never to 3=almost always). The final score ranges from 0 to 27 and it is obtained adding the scores of each of the items. Four exclusive groups can be differentiated based on this score: 0=non-problem gambler; 1-2= low-risk gambler who experiences few problems and any or few negative consequences; 3-7= moderate-risk gambler experiencing moderate problems with some negative consequences; 8 or more= problem gambler. It presents a one-dimensional structure, the reliability of the general scale is excellent (0.97) and the construct validity is satisfactory. Although the PGSI is not a diagnostic tool, in terms of convergent validity, the scale shows good precision and power (sensitivity= 0.93 and specificity=0.79) in a sample of sports bettors from the general population.

  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. [ Time Frame: Up to 12 months ]
    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).

  3. 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. [ Time Frame: Up to 12 months ]
    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.

  4. 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. [ Time Frame: Up to 12 months ]
    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.

  5. 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 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.

  6. Gambling self-register (Echeburúa y Báez, 1994) during procedure. [ Time Frame: During procedure ]
    It is a self-register that allows detecting individual circumstances that trigger gambling behaviour and its consequences. It includes the date, time, thoughts, places and time spent, type of game, company, money spent, and the consequences experienced.

  7. Change in the urge to gamble during procedure. [ Time Frame: During procedure ]
    Urge to gamble is measured in a 10-point Likert scale.

  8. Change in the self-efficacy to control gambling during procedure. [ Time Frame: During procedure ]
    Self-efficacy to control gambling is measured in a 10-point Likert scale.

  9. Gambling history interview and current gambling situation and related variables assessment at the pre-intervention. [ Time Frame: Pre-intervention ]
    This interview is based on the Structured Interview of Gambling History (Echeburúa & Báez, 1994). In addition to making a selection of five of the items of the first interview to assess parents' gambling habits, the onset, and aggravation of the patient's gambling behaviour (including ups and downs and periods of abstinence), other five interesting items of variables related to the current gambling situation are added. They are referred to economic debts, to which people or entities they owe money and the specific amount, if they have access to money and the forms through which they can access, what they have done so far to solve the problem, how long it has happened since the last bet and the specific risk places. The 10 items are open-ended questions and offer qualitative data to understand the participants' context and gambling situation.


Other Outcome Measures:
  1. Mini International Neuropsychiatric Interview - The M.I.N.I. 7.0.2, 8/8/16 version (Sheehan, 2016). [ Time Frame: Pre-intervention. ]
    MINI is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5 (major depressive episode; obsessive-compulsive disorder; posttraumatic stress disorder; alcohol use disorder; substance use disorder; any psychotic disorder; anorexia nervosa; bulimia nervosa; generalized anxiety disorder; medical, organic, drug cause ruled out; and antisocial personality disorder). Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if it is needed. Validity and reliability are supported and similar properties to the SCID-P for DSM-III-R and the CIDI are shown, but it can be administered in a much shorter period of time.

  2. Change in the Beck Depression Inventory (BDI-II; Beck, Steer & Brown, 1996; Spanish validation Sanz, García-Vera, Espinosa, Fortún & Vázquez, 2005) at Pre-intervention, Post-intervention, 3-, 6-, and 12 months Follow-up. [ Time Frame: Up to 12 months ]
    BDI-II is a self-report instrument that consists of 21 items and evaluates depressive symptoms severity, specifically two different factors (somatic-motivational and cognitive factors). Respondents are asked to indicate which option most suits themselves taking into account the last two weeks. There are four options organized from lower to larger severity and each item is scored from 0 to 3. More than one option can be chosen, and in that case, the score of the greater severity is selected to calculate the total score. Global score is obtained adding all items values, and it ranges from 0 to 63 (0-13=minimal depression; 14-19= mild depression; 20-28= moderate depression; 29 or more= severe depression). The internal consistency is high (α=0.89) and convergent and discriminant validities are supported. All in all, this instrument is valid for assessing depressive symptoms in psychiatric patients.

  3. Change in the Overall Depression Severity and Impairment Scale (ODSIS; Bentley, Gallagher, Carl & Barlow, 2014; Spanish validation Mira et al., 2019) at Pre-intervention, Post-module, Post-intervention, 3-, 6-, and 12 months Follow-up. [ Time Frame: Up to 12 months ]
    ODSIS is a 5-item self-report instrument that evaluates a unidimensional factor referred to the severity and functional impairment associated with depression during the last week. There are five response options for each item and they are coded from 0 to 4. The total score is obtained adding the values of all the items and it ranges from 0 to 20. Scores of 5 or higher indicate depressive symptoms. This scale is validated online considering a sample of patients with depressive or anxiety disorders. It shows an excellent internal consistency (α=0.92), and the construct, convergent and discriminant validities are evidenced.

  4. Change in the Overall Anxiety Severity and Impairment Scale (OASIS; Campbell-Sills et al., 2009; Spanish validation González-Robles et al., 2018) at Pre-intervention, Post-module, Post-intervention, 3-, 6-, and 12 months Follow-up. [ Time Frame: Up to 12 months ]
    OASIS is a 5-items self-report instrument that assesses a unidimensional factor referred to the severity and frequency of anxiety symptoms, as well as to the behavioral avoidance and the functional impairment related to these symptoms in the previous week. There are five response options for each item and they are coded from 0 to 4. The total score is obtained adding the values of all the items and it ranges from 0 to 20. Scores higher than 8 show the occurrence of anxiety symptoms. This scale is validated online in a sample of patients with depression and anxiety. It shows good internal consistency (α=0.86) and adequate convergent and discriminant validities, as well as sensitivity to change.

  5. 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. [ Time Frame: Up to 12 months ]
    DERS is a self-report measure that includes 28 items and it assesses five factors related to difficulties in emotion regulation processes: emotional lack of control, life interference, lack of emotional attention, emotional confusion, and emotional rejection. Participants should report in a 5-point Likert type scale how often the items are applied for themselves from 1 (almost never; 0-10%) to 5 (almost always; 91-100%). A score for each subscale is obtained adding the values of the set of items that correspond to each subscale and taking into account reversed items. A final score is obtained adding the values of all items. The higher scores the higher difficulties in emotion regulation processes. DERS has good psychometric properties in the general population. Internal consistency is 0.93, test-retest reliability is adequate, and convergent and incremental validities are evidenced.

  6. 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. [ Time Frame: Up to 12 months ]
    The PANAS is made up of 20 items that assess two independent dimensions, positive affect (PA) and negative affect (NA). PANAS is used for measuring trait and state affectivity. Each dimension consists of 10 items which are rated on a 5-point Likert type scale (1=very slightly or not at all; 2= a little; 3=moderately; 4; quite a bit; 5=very much). Participants should indicate to what extent they have experienced each emotion generally and during the last week. Total scores are calculated adding the values of the items for each dimension, and it ranges from 10 to 50. Psychometric properties are not yet available since the Spanish validation in clinical patients is ongoing, but Cronbach's alpha will be calculated with the data at hand.

  7. 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. [ Time Frame: Up to 12 months ]
    UPPS-P assess five impulsivity traits (negative urgency, lack of premeditation, lack of perseverance, sensation seeking and positive urgency) through 20 four-point Likert scale items (1=strongly agree; 4=strongly disagree). Scores of each of the five factors and a global score of the UPPS-P are obtained taking into account direct and inverse items. It is calculated adding the values of the four items that include each factor. The higher the score the higher impulsivity. UPPS-P present good psychometric properties in a sample of university students. Internal consistency is acceptable (α ranges from 0.61 to 0.81) and external validity is supported.

  8. 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. [ Time Frame: Up to 12 months ]
    QLI is a 10-item self-report instrument that assess one concept of quality of life taking into account 10 dimensions on a ten-point Likert type scale (1=poor; 10=excellent): physical well-being, psychological/emotional well-being, self-care and independent functioning, occupational functioning, interpersonal functioning, social-emotional support, community and services support, personal fulfillment, spiritual fulfillment and global perception of quality of life. Total score corresponds to the average of the scores of the set of items and rages from 1 to 10 (1-4,5=perception of the quality of life below the average; 4,6-8,1= perception of the quality of life in the average; 8,2-10=perception of the quality of life above average). Internal consistency (α=0.89) and test-retest reliability (0.89) are high, and the discriminant validity is evidenced in a sample of psychiatric patients.

  9. Change in the System Usability Scale (SUS; Castilla et al., 2016) at Pre-intervention and Post-intervention. [ Time Frame: Pre-intervention and immediately after the intervention. ]
    SUS is a 10-item self-report instrument aimed to assess the system usability opinion in a 5-Likert type scale that ranges from 1 ( Completely disagree) to 5 (Completely agree). Psychometric properties are not yet available since the Spanish validation in clinical patients is ongoing, but Cronbach's alpha will be calculated with the data at hand.



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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:

  • 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 risk gambler (1-2 affirmative items), 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 Alcohol and/or substance dependence 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).

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): NCT04074681


Contacts
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Contact: Laura Díaz Sanahuja, PhDstudent +34 964387651 lsanahuj@uji.es
Contact: Juana M Bretón López, Lecturer +34 964387642 breton@uji.es

Locations
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Spain
Jaume I University
Castelló, Spain, 12071
Contact: Juana M Bretón López, Lecturer    +34 964387642    breton@uji.es   
Contact: Azucena García Palacios, Lecturer    +34 964387640    azucena@uji.es   
Sponsors and Collaborators
Universitat Jaume I
Investigators
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Study Director: Juana M Bretón López, Lecturer Jaume I University
Study Director: Azucena García Palacios, Lecturer Jaume I University
Additional Information:
Publications:
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Responsible Party: Universitat Jaume I
ClinicalTrials.gov Identifier: NCT04074681    
Other Study ID Numbers: UJI-A2016-14
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitat Jaume I:
Gambling
CBT
Internet program
Efficacy
Additional relevant MeSH terms:
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Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders