Clinical trial NCT05331612: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gambling Disorder
Problem Gambling
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 30
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 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.

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.

Primary outcomes:
measure: Gambling Symptom Assessment Scale (Kim et al., 2009). At baseline, post-module, post-treatment, 3, 6 and 12 months follow-up.
timeFrame: Up to 12 months.
measure: Gambling-related cognitions scale (Del Prete et al., 2017). At baseline, post-treatment, 3, 6 and 12 months follow-ups.
timeFrame: Up to 12 months.
Secondary outcomes:
measure: Gambling Self-Efficacy Questionnaire (Winfree et al., 2013). At post-treatment, 3,6 and 12 months follow-ups.
timeFrame: Up to 12 months.
measure: The University of Rhode Island Change Assessment Scale (Gómez-Peña et al., 2011). At baseline, post-treatment, 3, 6 and 12 follow-ups.
timeFrame: Up to 12 months.
Other outcomes:
Locations:
city: Castelló de la Plana
country: Spain
facility: University Jaume I
state: Castelló
Study officials:
affiliation: University Jaume I
name: Juana Bretón López, Professor
role: STUDY_DIRECTOR
References: