Clinical trial NCT06681103: Intention to Change and Treatment-Seeking in Pathological Gamblers and Investors: an Experimental Study in Young Adults
Official title: Intention to Change and Treatment-Seeking in Pathological Gamblers and Investors: an Experimental Study in Young Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gambling Disorder
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Ministry of Social Rights, Consumer Affairs and 2030 Agenda
First posted: 2024-11-08
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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 472 men and women living in Spain, aged between 18 and 30 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.

Eligibility criteria: Participants' eligibility will be assessed based on sociodemographic variables and measures of quality of life, psychological distress, suicidal behavior, 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:

* Engaged in trading or gambling activities (land-based or online) at least once per month in the past 60 days
* Aged 18-30 years
* Reside in Spain
* Provide informed consent to participate in initial online assessment, post-test, and follow-up

Exclusion Criteria:

* Currently undergoing psychological or psychiatric treatment
* Diagnosed with alcohol or illicit drug dependence
* Scoring above 3 on the Oviedo Infrequency Scale (Fonseca-Pedrero et al., 2009), indicating potential random/pseudorandom or dishonest responses.

Primary outcomes:
measure: Intention to change
timeFrame: Baseline, immediate follow-up (after PONF), 3-month follow-up
measure: Treatment-seeking behavior
timeFrame: Baseline, immediate follow-up (after PONF), 3-month follow-up
Secondary outcomes:
measure: Gambling and trading behaviors
timeFrame: Baseline, immediate follow-up (after PONF), 3-month follow-up
measure: Disordered gambling
timeFrame: Baseline, immediate follow-up (after PONF), 3-month follow-up
measure: Disordered trading
timeFrame: Baseline, immediate follow-up (after PONF), 3-month follow-up
Other outcomes:
measure: Gambling and trading-related harms
timeFrame: Baseline and 3-month follow-up
measure: Gambling and trading self-efficacy
timeFrame: Baseline and 3-month follow-up
measure: Peer gambling and trading
timeFrame: Baseline
measure: Satisfaction and perceived usefulness
timeFrame: Immediate follow-up
Locations:
city: Elche
country: Spain
facility: Miguel Hernández University
state: Alicante
Study officials:
References: