Gambling DisorderNCT06681103
Online Intervention to Promote Change and Help-Seeking in Young Adults With Gambling and Trading Problems
A study testing Personalized Normative Feedback in people with Gambling Disorder, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
The goal of this study is to investigate if personalized online normative feedback (PONF) can increase intention to change and help-seeking behaviors in young adults with gambling or trading problems in Spain. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Gambling Disorder
- What is being tested?
- Personalized Normative Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,112 participants
- Where
- 1 siteSpain
- Study dates
- 20 Dec 2024to 30 Jun 2025
- 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 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Engaged in trading or gambling activities (land-based or online) at least once per month in the past 60 days
- Aged 18-34 years
- Residing in Spain
- Provide informed consent to participate in initial online assessment, post-test, and follow-up
Who cannot join
- Currently undergoing psychological or psychiatric treatment
- Scoring above 3 on the Oviedo Infrequency Scale (Fonseca-Pedrero et al., 2009), indicating potential random/pseudorandom or dishonest responses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online Personalized Normative Feedback to Foster Intention to Change and Help-Seeking in Young Adults With Gambling- and Trading-Related Problems: An Experimental Study
The goal of this study is to investigate if personalized online normative feedback (PONF) can increase intention to change and help-seeking behaviors in young adults with gambling or trading problems in Spain. The main questions it aims to answer are:
- Does PONF increase intention to change and help-seeking behaviors?
- How does receiving PONF affect gambling and trading behaviors?
Read more
Researchers will compare three groups:
- Evaluation group: A control group with pre- and post-assessments.
- Delayed evaluation group: A control group with only a post-assessment, to control for the effect of the assessment.
- FNPO group: An intervention group receiving PONF after the initial evaluation and completing both pre- and post-assessments.
Participants will:
- Receive PONF or no feedback at the first evaluation.
- Complete initial and follow-up assessments after 12 weeks.
Read the detailed description
Despite the availability of treatment options, the percentage of individuals with problem gambling who seek help or treatment remains low. To reach a larger number of pathological gamblers, other forms of online or self-guided interventions have been developed, with personalised normative feedback (NPF) being the most widely applied modality in the prevention of problem gambling in the young adult population. However, the majority of studies on the efficacy of PNF only assess its impact on the intensity and severity of gambling behaviour, and do not analyse its potential effect on increasing intention to change and treatment-seeking behaviour. Furthermore, there is a lack of studies analyzing the efficacy of NPF in reducing new forms of online money spending linked to pathological gambling, such as betting on video games and excessive trading of financial assets, including cryptocurrencies.
The present project has two objectives: (1) to quantify the intention to change and the prevalence of help-seeking behaviours in the Spanish young adult population with pathological gambling or trading behaviours; and (2) to analyze the effectiveness of personalised online normative feedback (PONF) to increase intention to change and help-seeking in this population.
The study will employ a randomised controlled design (three Solomon groups) with one intervention group and two control groups. The study will involve a sample of at least 656 men and women living in Spain, aged between 18 and 34 years. The impact of receiving FNPO on gambling and trading behaviour will be analysed over a 12-week period. This will include an assessment of the intention to change and treatment seeking, as well as the longitudinal trajectory of gambling and trading behaviours (in terms of intensity, frequency and severity). Furthermore, individual, interpersonal and contextual factors will be evaluated in order to ascertain the profile of those with gambling and trading issues who may derive the greatest benefit from this type of intervention.
This project is pioneering both nationally and internationally. Furthermore, this study will assess for the first time the intention to change and help-seeking in young adults with gambling behaviour (in traditional and new formats such as video games) and pathological trading. It will also develop and analyze the effectiveness of the first tool to mobilize change and reduce the prevalence of these behaviours. Furthermore, the study design will enable an independent assessment of the impact of both the intervention and the assessment of pathological gambling and trading behaviours on the individual.
- Conditions
- Gambling Disorder
- Being tested
- Personalized Normative Feedback
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Normative FeedbackBehavioural
Those participating in this condition will receive a personalised brief report which summarises the results of their initial assessment. The PONF will comprise the following elements: (1) Details of the main gambling and trading activities performed, including frequency of engagement and amount of money spent; (2) Scores on the criteria of pathological trading and/or PGSI (problem gambling), together with an interpretation of the results and the level of severity. All results will be accompanied by graphs enabling participants to compare their scores with the average scores of the Spanish population of the same sex and age range. To prevent an increase in behaviour in participants whose frequency or intensity of gambling/trading is below the norm, as recommended by Newall et al. (2023), the normative data will include extreme averages and percentages. All participants assigned to the PNF intervention receive identical feedback content, regardless of assessment sequencing.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Online Normative Feedback (PONF) | Experimental | Participants in this group complete a pre-assessment measuring intention to change, help-seeking behavior, and gambling and trading behaviors (e.g., frequency and spending). They then receive personalized online normative feedback (PONF) based on their initial assessment and subsequently complete a post-assessment including the same outcomes.
Within this intervention arm, participants are randomly assigned to one of two predefined assessment sequences (PNF-A vs. PNF-B), differing only in the timing of the post-intervention assessment of gambling and trading behaviors. This sequencing is implemented exclusively to support secondary analyses of potential reporting reactivity (e.g., social desirability) and does not involve any differences in intervention content, delivery, or assessment of the primary motivational outcomes. Receives: Behavioral: Personalized Normative Feedback |
| Control group 1 (Assessment group) | No intervention | Participants in this group will complete both pre- and post-assessments on intention to change, help-seeking behavior, and gambling/trading behaviors. However, they will not receive any feedback. This group serves as a comparison to both intervention groups. |
| Control group 2 (Delayed Assessment Group) | No intervention | This group will complete only the post-assessment, measuring intention to change, help-seeking behavior, and gambling/trading behaviors, without completing a pre-test or receiving feedback, to independently analyze the immediate effects of the pre-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to change
The study will assess intention to change and help-seeking behavior using three custom items. In the initial assessment, participants will respond to a dichotomous question regarding whether they have considered reducing or abandoning gambling/trading in the past year. They will also rate the likelihood of engaging in these behaviors over the next 12 months on a scale from 0% (not likely) to 100% (very likely). Finally, participants will indicate their goal regarding their gambling/trading behavior, choosing from options to reduce, increase, maintain, or cease the behavior.
Measured: Baseline, immediate follow-up (after PONF), 3-month follow-up
Treatment-seeking behavior
Treatment-seeking behavior will be assessed during the initial evaluation using a the following question: "Have you ever sought professional help, advice from family or friends, or done something on your own to limit or reduce your [gambling/trading] behavior?" If participants answer "yes," they will complete the Help-Seeking Questionnaire (HSQ), which includes 14 items assessing in-person (e.g., seeing a psychologist), remote (e.g., calling a helpline), and self-directed (e.g., reading forums or searching websites) help-seeking behaviors.
Measured: Baseline, immediate follow-up (after PONF), 3-month follow-up
Secondary outcomes (3)
Gambling and trading behaviors
The frequency and intensity of gambling and trading behaviors will be assessed with ad-hoc items. Gambling behavior will be evaluated with reference to the last year during the initial and post-test assessments, and for the last month during the 3-month follow-up. Trading behavior will focus on financial operations, types of trading, and frequency of market monitoring. A dichotomous item will also assess whether participants engage in professional or amateur trading.
Measured: Baseline, immediate follow-up (after PONF), 3-month follow-up
Disordered gambling
The Problem Gambling Severity Index (PGSI) and the Gambling Disorder Identification Test (GDIT) will be used to assess problem gambling. The Problem Gambling Severity Index (9 items) categorises participants as non-problem, low-risk, moderate-risk, or problem gambling. The total score ranges from 0 to 27, with higher scores indicating a greater severity of gambling problems.
The investigators will adapt the Gambling Disorder Identification Test, a 14-item Likert scale, to Spanish and validate it as a new measure. It evaluates gambling behaviours, symptoms, and negative consequences, categorising participants as non-gamblers, recreational gamblers, or problematic gamblers (mild, moderate, severe). The total score of the scale ranges from 0 to 62, with higher scores indicating more severe gambling disorder.
Measured: Baseline, 3-month follow-up
Disordered trading
Trading Disorder Scale which is based on the diagnostic criteria for gambling disorder from the DSM-5, adapted to evaluate problematic trading behaviors. This scale evaluates various dimensions of addictive behavior, including tolerance, withdrawal, loss of control, craving, social impairment, and continued engagement despite negative consequences. The total score of the scale ranges from 0 to 13, with scores ≥5 indicates the possible presence of disordered trading.
Measured: Baseline, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start20 Dec 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This design follows a Solomon three-group structure, enabling the independent evaluation of the immediate effects that the pre-test assessment and the intervention may have on the study's dependent variables (intention to change and help-seeking behavior), as well as their maintenance three months after the intervention. The following experimental conditions will be established: (1) control group with pre- and post-test assessment (assessment group), (2) control group with post-test assessment only (delayed assessment group) and (3) intervention group with pre- and post-test assessment, which will also receive personalised online normative feedback on their gambling and trading behaviour after the initial assessment (PONF group). To adapt the PONF to each participant it is necessary to conduct a pre-test assessment, so an adaptation of Solomon's design will be used.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Derechos Sociales, Consumo y Agenda 2030, Spain
- Responsible party
- Principal investigator, Ainhoa Coloma Carmona, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681103
- Sponsor's protocol ID
- SUBV23/00004
- Status last verified
- Jan 2026
- First submitted
- 7 Nov 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coloma-Carmona A, Pons-Garcia N, Perez-Jover V, Miro-Llinares F, Carballo JL. Traditional gambling, betting in video games, and financial trading: Associations with gambling severity and associated harm in young adults. Adicciones. 2026 Mar 31;38(1):51-68. doi: 10.20882/adicciones.2512. English, Spanish.
PubMed 42104767Coloma-Carmona A, Carballo JL, Miro-Llinares F, Perez-Jover V. Online Personalized Normative Feedback to Foster Intention to Change and Help Seeking in Young Adults With Disordered Gambling and Trading Behaviors: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 23;15:e73155. doi: 10.2196/73155.
PubMed 41735784
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Personalized Normative Feedback to Foster Intention to Change and Help-Seeking in Young Adults With Gambling- and Trading-Related Problems: An Experimental Study
- ClinicalTrials.gov ID
- NCT06681103
- Acronym / sponsor ID
- SUBV23/00004
- Conditions
- Gambling Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,112 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Ministerio de Derechos Sociales, Consumo y Agenda 2030, Spain
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 8 Nov 2024 (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 goal of this study is to investigate if personalized online normative feedback (PONF) can increase intention to change and help-seeking behaviors in young adults with gambling or trading problems in Spain. The main questions it aims to answer are:
- Does PONF increase intention to change and help-seeking behaviors?
- How does receiving PONF affect gambling and trading behaviors?
Researchers will compare three groups:
- Evaluation group: A control group with pre- and post-assessments.
- Delayed evaluation group: A control group with only a post-assessment, to control for the effect of the assessment.
- FNPO group: An intervention group receiving PONF after the initial evaluation and completing both pre- and post-assessments.
Participants will:
- Receive PONF or no feedback at the first evaluation.
- Complete initial and follow-up assessments after 12 weeks.
Detailed description
Despite the availability of treatment options, the percentage of individuals with problem gambling who seek help or treatment remains low. To reach a larger number of pathological gamblers, other forms of online or self-guided interventions have been developed, with personalised normative feedback (NPF) being the most widely applied modality in the prevention of problem gambling in the young adult population. However, the majority of studies on the efficacy of PNF only assess its impact on the intensity and severity of gambling behaviour, and do not analyse its potential effect on increasing intention to change and treatment-seeking behaviour. Furthermore, there is a lack of studies analyzing the efficacy of NPF in reducing new forms of online money spending linked to pathological gambling, such as betting on video games and excessive trading of financial assets, including cryptocurrencies.
The present project has two objectives: (1) to quantify the intention to change and the prevalence of help-seeking behaviours in the Spanish young adult population with pathological gambling or trading behaviours; and (2) to analyze the effectiveness of personalised online normative feedback (PONF) to increase intention to change and help-seeking in this population.
The study will employ a randomised controlled design (three Solomon groups) with one intervention group and two control groups. The study will involve a sample of at least 656 men and women living in Spain, aged between 18 and 34 years. The impact of receiving FNPO on gambling and trading behaviour will be analysed over a 12-week period. This will include an assessment of the intention to change and treatment seeking, as well as the longitudinal trajectory of gambling and trading behaviours (in terms of intensity, frequency and severity). Furthermore, individual, interpersonal and contextual factors will be evaluated in order to ascertain the profile of those with gambling and trading issues who may derive the greatest benefit from this type of intervention.
This project is pioneering both nationally and internationally. Furthermore, this study will assess for the first time the intention to change and help-seeking in young adults with gambling behaviour (in traditional and new formats such as video games) and pathological trading. It will also develop and analyze the effectiveness of the first tool to mobilize change and reduce the prevalence of these behaviours. Furthermore, the study design will enable an independent assessment of the impact of both the intervention and the assessment of pathological gambling and trading behaviours on the individual.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This design follows a Solomon three-group structure, enabling the independent evaluation of the immediate effects that the pre-test assessment and the intervention may have on the study's dependent variables (intention to change and help-seeking behavior), as well as their maintenance three months after the intervention. The following experimental conditions will be established: (1) control group with pre- and post-test assessment (assessment group), (2) control group with post-test assessment only (delayed assessment group) and (3) intervention group with pre- and post-test assessment, which will also receive personalised online normative feedback on their gambling and trading behaviour after the initial assessment (PONF group). To adapt the PONF to each participant it is necessary to conduct a pre-test assessment, so an adaptation of Solomon's design will be used.
| Arm | Type | Receives |
|---|---|---|
| Personalized Online Normative Feedback (PONF) | Experimental | Behavioral: Personalized Normative FeedbackParticipants in this group complete a pre-assessment measuring intention to change, help-seeking behavior, and gambling and trading behaviors (e.g., frequency and spending). They then receive personalized online normative feedback (PONF) based on their initial assessment and subsequently complete a post-assessment including the same outcomes. Within this intervention arm, participants are randomly assigned to one of two predefined assessment sequences (PNF-A vs. PNF-B), differing only in the timing of the post-intervention assessment of gambling and trading behaviors. This sequencing is implemented exclusively to support secondary analyses of potential reporting reactivity (e.g., social desirability) and does not involve any differences in intervention content, delivery, or assessment of the primary motivational outcomes. |
| Control group 1 (Assessment group) | No intervention | –Participants in this group will complete both pre- and post-assessments on intention to change, help-seeking behavior, and gambling/trading behaviors. However, they will not receive any feedback. This group serves as a comparison to both intervention groups. |
| Control group 2 (Delayed Assessment Group) | No intervention | –This group will complete only the post-assessment, measuring intention to change, help-seeking behavior, and gambling/trading behaviors, without completing a pre-test or receiving feedback, to independently analyze the immediate effects of the pre-test. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Engaged in trading or gambling activities (land-based or online) at least once per month in the past 60 days
- Aged 18-34 years
- Residing in Spain
- Provide informed consent to participate in initial online assessment, post-test, and follow-up
Key exclusion criteria (2 listed)
- Currently undergoing psychological or psychiatric treatment
- Scoring above 3 on the Oviedo Infrequency Scale (Fonseca-Pedrero et al., 2009), indicating potential random/pseudorandom or dishonest responses.
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 |
|---|---|---|
| Personalized Normative FeedbackThose participating in this condition will receive a personalised brief report which summarises the results of their initial assessment. The PONF will comprise the following elements: (1) Details of the main gambling and trading activities performed, including frequency of engagement and amount of money spent; (2) Scores on the criteria of pathological trading and/or PGSI (problem gambling), together with an interpretation of the results and the level of severity. All results will be accompanied by graphs enabling participants to compare their scores with the average scores of the Spanish population of the same sex and age range. To prevent an increase in behaviour in participants whose frequency or intensity of gambling/trading is below the norm, as recommended by Newall et al. (2023), the normative data will include extreme averages and percentages. All participants assigned to the PNF intervention receive identical feedback content, regardless of assessment sequencing. | Behavioural | Personalized Online Normative Feedback (PONF) |
Primary outcome
Intention to change
Time frame: Baseline, immediate follow-up (after PONF), 3-month follow-up
The study will assess intention to change and help-seeking behavior using three custom items. In the initial assessment, participants will respond to a dichotomous question regarding whether they have considered reducing or abandoning gambling/trading in the past year. They will also rate the likelihood of engaging in these behaviors over the next 12 months on a scale from 0% (not likely) to 100% (very likely). Finally, participants will indicate their goal regarding their gambling/trading behavior, choosing from options to reduce, increase, maintain, or cease the behavior.
Treatment-seeking behavior
Time frame: Baseline, immediate follow-up (after PONF), 3-month follow-up
Treatment-seeking behavior will be assessed during the initial evaluation using a the following question: "Have you ever sought professional help, advice from family or friends, or done something on your own to limit or reduce your [gambling/trading] behavior?" If participants answer "yes," they will complete the Help-Seeking Questionnaire (HSQ), which includes 14 items assessing in-person (e.g., seeing a psychologist), remote (e.g., calling a helpline), and self-directed (e.g., reading forums or searching websites) help-seeking behaviors.
3 secondary outcomes
Gambling and trading behaviors
Time frame: Baseline, immediate follow-up (after PONF), 3-month follow-up
Disordered gambling
Time frame: Baseline, 3-month follow-up
Disordered trading
Time frame: Baseline, 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 42104767Coloma-Carmona A, Pons-Garcia N, Perez-Jover V, Miro-Llinares F, Carballo JL. Traditional gambling, betting in video games, and financial trading: Associations with gambling severity and associated harm in young adults. Adicciones. 2026 Mar 31;38(1):51-68. doi: 10.20882/adicciones.2512. English, Spanish.
- Derived from this study: PubMed 41735784Coloma-Carmona A, Carballo JL, Miro-Llinares F, Perez-Jover V. Online Personalized Normative Feedback to Foster Intention to Change and Help Seeking in Young Adults With Disordered Gambling and Trading Behaviors: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 23;15:e73155. doi: 10.2196/73155.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Normative Feedback in people with Gambling Disorder, run by Universidad Miguel Hernandez de Elche 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention to change (time frame: Baseline, immediate follow-up (after PONF), 3-month follow-up). 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?
On the ClinicalTrials.gov record for NCT06681103, which also lists 2 linked publications.
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 30 Jan 2026.