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Blended Treatment for Problem Gambling and Gambling Disorder Combining Group Sessions and Online Modules

Primary Purpose

Gambling Disorder, Problem Gambling

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Blended intervention condition
Sponsored by
Universitat Jaume I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gambling Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older.
  • Being able to understand, read and write Spanish.
  • Having a computer and daily access to the Internet at home.
  • Meeting criteria for gambling disorder or problem gambling according to the parameters established by the Norc Diagnostic Screening for gambling disorders (NODS) (Becoña, 2004),
  • Availability and willingness to provide information about gambling behavior in the follow-ups.

Exclusion Criteria:

  • Having any serious mental disorder.
  • If the behavior comes to maniac from a maniac episode or from taking antidepressants
  • Being high risk of suicide,
  • Moderate or severe alcohol and substance use disorder according to the Mini International Neuropsychiatric Interview (MINI) (Sheehan et al.,1998).
  • Any medical illness that conditions receiving treatment receives.
  • Increasing in the dose of pharmacological treatment.

Sites / Locations

  • University Jaume I

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Blended intervention condition

Waiting list control condition

Arm Description

Blended intervention condition, consisting of 5 face-to-face group sessions lasting 2 hours every 2 weeks, alternated with the online treatment protocol carried out by the participants in a self-applied. The intervention has a period of duration of 13 weeks and it is composed by 8 modules (Motivation for change, Psychoeducation, Stimulus control, Cognitive restructuring, Urge surfing and emotion regulation, Planning of significant activities, Coping skills and exposure with response prevention, and Relapse prevention). These modules is based in the online platform and manualized protocol treatment "Sin jugar, ganas" (Díaz-Sanahuja et al., 2021).

Waiting list control group receives the blended treatment when the intervention has finished in the experimental group (blended group intervention).

Outcomes

Primary Outcome Measures

Gambling Symptom Assessment Scale (Kim et al., 2009). At baseline, post-module, post-treatment, 3, 6 and 12 months follow-up.
The G-SAS is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. All items are scored on a 4-point scale, and the score ranges from 0 to 48: extreme=41-48, severe=31-40, moderate=21-30 and mild=8-20. The scale shows a higher internal consistency (α = 0.82).
Gambling-related cognitions scale (Del Prete et al., 2017). At baseline, post-treatment, 3, 6 and 12 months follow-ups.
The GRCS is a self-report which assessed the gambling cognitions through 23 items divided into 5 dimensions that are rated on a 7-point Likert-type scale (1 = I strongly disagree; 7 = I strongly agree). The reliability of each of the dimensions is adequate ID (α = 0.79), in adequate EJ (α = 0.72), in adequate CI (α = 0.7), in adequate PC (α = 0.73) and in good SI (α = 0.8). The degree of internal consistency of the total score of the scale was better (α = 0.9).

Secondary Outcome Measures

Gambling Self-Efficacy Questionnaire (Winfree et al., 2013). At post-treatment, 3,6 and 12 months follow-ups.
The GSEQ is a self-report measure to assess an individual's perceived self-efficacy to control his or her gambling behavior in a variety of situations through 16 six-point Likert scale items. The total score is calculated through the average response given among all the items on the scale, ranging from 0 to 100. Higher scores denote greater confidence in the gambling behavior by the patient. It has shown a good internal consistency of .96.
The University of Rhode Island Change Assessment Scale (Gómez-Peña et al., 2011). At baseline, post-treatment, 3, 6 and 12 follow-ups.
The URICA is a self-report measure that includes 4 subscales measuring the stages of change of Prochaska & DiClemente (Pre-contemplation, Contemplation, Action, and Maintenance) (there is also a 24-item version) through 32 ítems. Responses are given on a 5-point Likert scale ranging from (1=strong disagreement to 5=strong agreement) (McConnaughy et al.,1983).The scores of each of the subscales range from 8 to 40, they are obtained through the five items that make up each of these. It shows internal consistency of .74.

Full Information

First Posted
March 1, 2022
Last Updated
June 13, 2022
Sponsor
Universitat Jaume I
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1. Study Identification

Unique Protocol Identification Number
NCT05331612
Brief Title
Blended Treatment for Problem Gambling and Gambling Disorder Combining Group Sessions and Online Modules
Official Title
Blended Treatment for Problem Gambling and Gambling Disorder Combining Group Sessions and Online Modules: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitat Jaume I

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main objective of present project is assess the preliminary efficacy of a blended psychological intervention, by comparing the improvements in the CBT and waiting list control groups of an evidence-based treatment protocol for problems related to gambling applied in a blended format (sessions through an online protocol treatment combining with face-to-face group sessions), as well as to evaluate the opinion and acceptance of the intervention.
Detailed Description
Gambling disorder and problem gambling are considered a public health problem around the world, not only because of the high costs of the treatments that it entails, otherwise by the increase in the numbers of young people who easily fall into gambling behavior and who can hardly leave problems with games of chance on their own. The review of the scientific literature has shown that CBT is the psychological therapy that has shown the greatest scientific evidence and rigor over the years in the treatment of gambling disorder and problem gambling. In addition, the application of Information and Communication Technologies (ICTs), together with the characteristics of accessibility, immediacy and cost reduction, which show, has made it possible to carry out effective Internet-delivered Interventions. If investigators take into account the high rates of drop outs and the low adherence to treatment that exists among patients with behavioral addictions, as well as the current barriers encountered by patients, such as stigma, the costs of the sessions and the distance geographical location. A new alternative and innovative treatment are blended interventions, although their research is still limited, their efficiency and effectiveness have been proven for the treatment of emotional disorders and substance addictions, such as smoking cessation. In the same way, the benefits which offers CBT group therapy are improvement the self-esteem, encourages problem solving and communication skills and mutual support. Therefore, the objective of the present project will be to evaluate whether a blended intervention (group sessions plus Internet-based modules) for problem gambling and gambling disorder could lead to improved gambling outcomes compared to a waiting list control condition.The minimum number of participants diagnosed with gambling disorder and problem gambling, which will be randomly assigned to each of the two conditions, will be 30 participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling Disorder, Problem Gambling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blended intervention condition
Arm Type
Experimental
Arm Description
Blended intervention condition, consisting of 5 face-to-face group sessions lasting 2 hours every 2 weeks, alternated with the online treatment protocol carried out by the participants in a self-applied. The intervention has a period of duration of 13 weeks and it is composed by 8 modules (Motivation for change, Psychoeducation, Stimulus control, Cognitive restructuring, Urge surfing and emotion regulation, Planning of significant activities, Coping skills and exposure with response prevention, and Relapse prevention). These modules is based in the online platform and manualized protocol treatment "Sin jugar, ganas" (Díaz-Sanahuja et al., 2021).
Arm Title
Waiting list control condition
Arm Type
No Intervention
Arm Description
Waiting list control group receives the blended treatment when the intervention has finished in the experimental group (blended group intervention).
Intervention Type
Behavioral
Intervention Name(s)
Blended intervention condition
Other Intervention Name(s)
BI
Intervention Description
Participants receive the online protocol treatment and face-to-face sessions during 13 weeks.
Primary Outcome Measure Information:
Title
Gambling Symptom Assessment Scale (Kim et al., 2009). At baseline, post-module, post-treatment, 3, 6 and 12 months follow-up.
Description
The G-SAS is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. All items are scored on a 4-point scale, and the score ranges from 0 to 48: extreme=41-48, severe=31-40, moderate=21-30 and mild=8-20. The scale shows a higher internal consistency (α = 0.82).
Time Frame
Up to 12 months.
Title
Gambling-related cognitions scale (Del Prete et al., 2017). At baseline, post-treatment, 3, 6 and 12 months follow-ups.
Description
The GRCS is a self-report which assessed the gambling cognitions through 23 items divided into 5 dimensions that are rated on a 7-point Likert-type scale (1 = I strongly disagree; 7 = I strongly agree). The reliability of each of the dimensions is adequate ID (α = 0.79), in adequate EJ (α = 0.72), in adequate CI (α = 0.7), in adequate PC (α = 0.73) and in good SI (α = 0.8). The degree of internal consistency of the total score of the scale was better (α = 0.9).
Time Frame
Up to 12 months.
Secondary Outcome Measure Information:
Title
Gambling Self-Efficacy Questionnaire (Winfree et al., 2013). At post-treatment, 3,6 and 12 months follow-ups.
Description
The GSEQ is a self-report measure to assess an individual's perceived self-efficacy to control his or her gambling behavior in a variety of situations through 16 six-point Likert scale items. The total score is calculated through the average response given among all the items on the scale, ranging from 0 to 100. Higher scores denote greater confidence in the gambling behavior by the patient. It has shown a good internal consistency of .96.
Time Frame
Up to 12 months.
Title
The University of Rhode Island Change Assessment Scale (Gómez-Peña et al., 2011). At baseline, post-treatment, 3, 6 and 12 follow-ups.
Description
The URICA is a self-report measure that includes 4 subscales measuring the stages of change of Prochaska & DiClemente (Pre-contemplation, Contemplation, Action, and Maintenance) (there is also a 24-item version) through 32 ítems. Responses are given on a 5-point Likert scale ranging from (1=strong disagreement to 5=strong agreement) (McConnaughy et al.,1983).The scores of each of the subscales range from 8 to 40, they are obtained through the five items that make up each of these. It shows internal consistency of .74.
Time Frame
Up to 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older. Being able to understand, read and write Spanish. Having a computer and daily access to the Internet at home. Meeting criteria for gambling disorder or problem gambling according to the parameters established by the Norc Diagnostic Screening for gambling disorders (NODS) (Becoña, 2004), Availability and willingness to provide information about gambling behavior in the follow-ups. Exclusion Criteria: Having any serious mental disorder. If the behavior comes to maniac from a maniac episode or from taking antidepressants Being high risk of suicide, Moderate or severe alcohol and substance use disorder according to the Mini International Neuropsychiatric Interview (MINI) (Sheehan et al.,1998). Any medical illness that conditions receiving treatment receives. Increasing in the dose of pharmacological treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ainara Muñoz Ranchel, PhD Student
Phone
967041239
Email
al373650@uji.es
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana Mira Pastor, Professor
Phone
964387651
Email
miraa@uji.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juana Bretón López, Professor
Organizational Affiliation
University Jaume I
Official's Role
Study Director
Facility Information:
Facility Name
University Jaume I
City
Castelló de la Plana
State/Province
Castelló
ZIP/Postal Code
12071
Country
Spain

12. IPD Sharing Statement

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Blended Treatment for Problem Gambling and Gambling Disorder Combining Group Sessions and Online Modules

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