Gambling DisorderNCT05331612
Blended Treatment for Problem Gambling and Gambling Disorder Combining Group Sessions and Online Modules
A study testing Blended intervention condition in people with Gambling Disorder and Problem Gambling, run by Universitat Jaume I at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gambling Disorder, Problem Gambling
- What is being tested?
- Blended intervention condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2022to Jul 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blended Treatment for Problem Gambling and Gambling Disorder Combining Group Sessions and Online Modules: A Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Gambling Disorder, Problem Gambling
- Being tested
- Blended intervention condition
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blended intervention conditionBehavioural
Also called BI
Participants receive the online protocol treatment and face-to-face sessions during 13 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Blended intervention condition | Experimental | 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). Receives: Behavioral: Blended intervention condition |
| Waiting list control condition | No intervention | Waiting list control group receives the blended treatment when the intervention has finished in the experimental group (blended group intervention). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 12 months.
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).
Measured: Up to 12 months.
Secondary outcomes (2)
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.
Measured: Up to 12 months.
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.
Measured: Up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study startOct 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juana Bretón López, Professor, Study director, University Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331612
- Sponsor's protocol ID
- ARAMENI/189
- Status last verified
- Jun 2022
- First submitted
- 1 Mar 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blended Treatment for Problem Gambling and Gambling Disorder Combining Group Sessions and Online Modules: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05331612
- Acronym / sponsor ID
- ARAMENI/189
- Conditions
- Gambling Disorder, Problem Gambling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blended intervention condition | Experimental | Behavioral: Blended intervention conditionBlended 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 condition | No intervention | –Waiting list control group receives the blended treatment when the intervention has finished in the experimental group (blended group intervention). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blended intervention conditionAlso: BIParticipants receive the online protocol treatment and face-to-face sessions during 13 weeks. | Behavioural | Blended intervention condition |
Primary outcome
Gambling Symptom Assessment Scale (Kim et al., 2009). At baseline, post-module, post-treatment, 3, 6 and 12 months follow-up.
Time frame: Up to 12 months.
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.
Time frame: Up to 12 months.
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).
2 secondary outcomes
Gambling Self-Efficacy Questionnaire (Winfree et al., 2013). At post-treatment, 3,6 and 12 months follow-ups.
Time frame: Up to 12 months.
The University of Rhode Island Change Assessment Scale (Gómez-Peña et al., 2011). At baseline, post-treatment, 3, 6 and 12 follow-ups.
Time frame: Up to 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
Related trials for Gambling Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 2
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
Gambling Disorder
Recruiting
Digital Cognitive Behavioral Therapy for Gambling Disorder
Gambling Disorder, Gambling
RecruitingObservational study
Is Craving a Central Criterion for Diagnosing a Behavioral Addiction?
Addictive Behaviors, Internet Addiction Disorder
Not yet recruiting
COMpulsive Gambling: Efficacy of DEEP Transcranial Magnetic Stimulation With H7 COIL
Gambling Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juana Bretón López, Professor study director
University Jaume I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blended intervention condition in people with Gambling Disorder and Problem Gambling, run by Universitat Jaume I at 1 site in Spain.
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 5 inclusion and 6 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 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ainara Muñoz Ranchel, PhD Student (967041239, al373650@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gambling Symptom Assessment Scale (Kim et al., 2009). At baseline, post-module, post-treatment, 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?
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 16 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.