ACT-Based Intervention for Problem Gambling (jugACT)

July 15, 2025 updated by: Universidad Europea de Madrid

Efficacy of a Group Intervention Grounded in Acceptance and Commitment Therapy (ACT) to Address Problem Gambling in Youth: A Randomized Clinical Trial

The goal of this randomized clinical trial is to study if Acceptance and Commitment Therapy (ACT) is effective to treat Problem Gambling in young adults.The main questions it aims to answer are:

  • Does ACT therapy improve health and gambling behavior?
  • Are the clinical improvements of youth with gambling disorder receiving ACT-based intervention significantly greater than the clinical improvements of youth with gambling disorder on the waiting list?

Researchers will assess whether changes in health, gambling behavior, and other psychological variables are observed after eight weeks of therapy.

Participants will:

  • Attend weekly online group sessions for 8 weeks
  • Learn new tools that they will put into practice after the sessions
  • Be required to complete evaluation questionnaires before and after the intervention and at the 3- and 6-month follow-up

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.

Patients who meet eligibility requirements will receive psychological intervention consisting in an 8-session group on line-delivered ACT-based treatment.

The participants will be assessed through self-report instruments before and after treatment and at 3 and 6 months follow-up.

The clinical trial will include a control group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 25 years
  • Score ≥ 3 on the Problem Gambling Severity Index (PGSI)
  • Comprehension of Spanish, online connection, and signed consent

Exclusion Criteria:

  • In active psychological or pharmacological treatment for gambling disorder
  • Having received ACT-based psychological treatment in the last 6 months
  • Problematic substance use: CAGE Adapted to Include Drugs Questionnaire (CAGE-AID) score ≥ 3
  • Difficulty consistently attending online sessions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACT group
8 individual weekly sessions which included ACT methods
Behavioral: Acceptance and Commitment Therapy (ACT)
Acceptance and Commitment Therapy methods were focused on promoting Values clarification, Acceptance, Cognitive defusion, Committed action and Flexible attention to the present moment, and included methods such as the Garden Metaphor or defusion training.
No Intervention: Waiting list
Participants assigned to Waiting List arm waited for 2 months before receiving treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Problem Gambling Severity Index (PGSI)
Time Frame: Change from Baseline severity of problem gambling at 8 months
The PGSI is a 9-item, 4-point Likert-format self-report scale (0 = never, 3 = almost always) that assesses the severity of problem gambling. Scores range from 0 to 27. A score of 8 or higher is considered indicative of problem gambling. Higher scores indicate greater severity of the disorder.
Change from Baseline severity of problem gambling at 8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Difficulties in Emotion Regulation Scale (DERS-28)
Time Frame: Change from Baseline emotion regulation at 8 months
he DERS-28 is a 28-item questionnaire with a 5-point Likert format (1 = almost never, 5 = almost always) that assesses difficulties in emotion regulation. It consists of six subscales: emotional nonacceptance, difficulty achieving goals, impulsivity, emotional awareness, limited strategies, and emotional clarity. Higher scores indicate greater difficulties in emotional regulation and worse clinical outcomes.
Change from Baseline emotion regulation at 8 months
Change in General Health Questionnaire (GHQ-12)
Time Frame: Change from Baseline psychological distress and perceived general health at 8 months
The GHQ-12 is a 12-item self-report questionnaire designed to detect general psychological symptoms. It is answered on a 4-point Likert-type scale. Higher scores reflect greater psychological distress and poorer perceived general health.
Change from Baseline psychological distress and perceived general health at 8 months
Change in the Comprehensive ACT Process Assessment Questionnaire (CompACT)
Time Frame: Change from Baseline psychological flexibility at 8 months
The CompACT is a 23-item, 7-point Likert-format scale (0 = not at all true, 6 = completely true) that assesses psychological flexibility, a core process of Acceptance and Commitment Therapy. It includes three subscales: openness to experience, awareness, and committed action. Higher scores reflect greater psychological flexibility.
Change from Baseline psychological flexibility at 8 months
Change in Values Living Questionnaire (VLQ)
Time Frame: Change from Baseline value-behavior alignment at 8 months
The Valued Living Questionnaire assesses the degree of perceived importance and consistency of action directed toward personal values in 10 life domains (family, work, health, leisure, etc.). Each item is scored from 1 to 10. A composite index of discrepancy between importance and action is calculated. Higher scores indicate less value-behavior alignment.
Change from Baseline value-behavior alignment at 8 months
Change in Gambling-Related Emotional Distress Scale
Time Frame: Change from Baseline gambling-related distress at 8 months
A weekly subjective scale assessing the frequency and intensity of emotional distress associated with gambling behavior using Likert scales ranging from 0 to 5. Higher scores reflect greater gambling-related distress.
Change from Baseline gambling-related distress at 8 months
Change in Gambling-Related Experiential Avoidance scale
Time Frame: Change from Baseline Experiential Avoidance at 8 months
A weekly subjective scale assessing the extent to which the participant has attempted to avoid gambling-related emotions, thoughts, or internal situations. Higher scores indicate greater experiential avoidance and less flexibility.
Change from Baseline Experiential Avoidance at 8 months
Change in the frequency of self-reported gambling behaviors
Time Frame: Change from Baseline gambling behaviors at 8 months
Daily self-monitoring in which the participant indicates whether they gambled, the duration, type of gambling, emotions before, during, and after, and perceived function of the behavior. Weekly frequency of gambling episodes will be analyzed. Higher frequency is interpreted as worse clinical outcome.
Change from Baseline gambling behaviors at 8 months
Change in the frequency of committed actions
Time Frame: Change from Baseline committed actions at 8 months
Self-monitoring of the frequency with which the participant has acted in accordance with their personal values during moments of desire to gamble. This is considered a positive behavioral indicator of change.
Change from Baseline committed actions at 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Europea de Madrid

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francisco Montesinos, Ph.D., Universidad Europea de Madrid
  • Principal Investigator: David Lobato, Ph.D., Universidad Europea de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEIm25/04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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