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CompletedNCT06681103Updated Jan 30, 2026

Online Intervention to Promote Change and Help-Seeking in Young Adults With Gambling and Trading Problems

An interventional study of Personalized Normative Feedback in Gambling Disorder, sponsored by Universidad Miguel Hernandez de Elche. Completed at 1 site in Spain. Open to participants aged 18 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-30.

Sponsored by Universidad Miguel Hernandez de Elche · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,112
Allocation
Randomized
Ages
18 Years to 34 Years
Sex
All
01

Study 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. Does PONF increase intention to change and help-seeking behaviors?
  2. 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.
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.

02

Conditions studied

  • Gambling Disorder

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03

In context

Gambling

158 studies on the registry are indexed under Gambling; 42 are open to participants now.

This study's enrollment of 1,112 is above the median of 66 across 128 interventional studies indexed under Gambling.

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Lead sponsor

Universidad Miguel Hernandez de Elche is the lead sponsor of 87 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 34 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Participants' eligibility will be assessed based on sociodemographic variables and measures of psychological distress, suicidal behavior, sleep quality and substance use. Eligible participants for the study on PONF's effect on intention to change and help-seeking behavior in young adults with gambling or trading problems must meet the following inclusion and exclusion criteria.

Inclusion criteria

Inclusion Criteria:

  • 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 to participate in initial online assessment, post-test, and follow-up

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
1,112 participants (actual)

Study arms

  • Experimental
    Personalized Online Normative Feedback (PONF)

    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.

    Behavioral: Personalized Normative Feedback

  • No intervention
    Control group 1 (Assessment group)

    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.

  • No intervention
    Control group 2 (Delayed Assessment Group)

    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.

Interventions

  • BehavioralPersonalized Normative Feedback

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, immediate follow-up (after PONF), 3-month follow-up

  2. 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.

    Time frame: Baseline, immediate follow-up (after PONF), 3-month follow-up

Secondary outcomes

  1. 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.

    Time frame: Baseline, immediate follow-up (after PONF), 3-month follow-up

  2. 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.

    Time frame: Baseline, 3-month follow-up

  3. 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.

    Time frame: Baseline, 3-month follow-up

Other outcomes

  1. Gambling and trading-related harms

    An adapted version of the Short Gambling Harm Screen will be used to evaluate harms related to both gambling and trading activities, employing a yes/no response format. Scores range from 0 to 10, with higher scores indicating greater gambling/trading-related harm.

    Time frame: Baseline and 3-month follow-up

  2. Gambling and trading self-efficacy

    The Brief Situational Questionnaire, adapted for gambling and trading behaviors, will assess self-efficacy in resisting gambling or trading across 10 specific scenarios. Scores range from 0 to 100, reflecting the degree of self-efficacy to resist these behaviors, with higher scores indicating stronger self-efficacy in handling such situations.

    Time frame: Baseline and 3-month follow-up

  3. Peer gambling and trading

    It will be assessed using a custom dichotomous item (yes/no) that evaluates whether the participant's friends or family engage in gambling, trading or financial investments.

    Time frame: Baseline

  4. Satisfaction and perceived usefulness

    Feedback on the satisfaction with the personalized normative feedback received and the perceived usefulness of the information provided will be assessed using a 4-point Likert questionnaire (only in intervention groups). Scores range from 1 to 4, with higher scores reflect greater satisfaction and perceived usefulness of the PONF.

    Time frame: Immediate follow-up

07

Study locations

1 site
  • Miguel Hernández University
    Elche, Alicante 03202, Spain
08

References and documents

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 42104767 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06681103
Lead sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Ministerio de Derechos Sociales, Consumo y Agenda 2030, Spain
Responsible party
Ainhoa Coloma Carmona (PhD, Universidad Miguel Hernandez de Elche) — Principal investigator
First posted
Nov 8, 2024
Start date
Dec 20, 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025
Last update
Jan 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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