- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07066501
- Original Trial
ACT-Based Intervention for Problem Gambling (jugACT)
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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Francisco Montesinos, Ph.D.
- Phone Number: 647143773
- Email: francisco.montesinos@universidadeuropea.es
Study Contact Backup
- Name: Ruben Perez
- Phone Number: +34686822991
- Email: ruben.perez@universidadeuropea.es
Study Locations
-
-
Madrid
-
Villaviciosa de Odón, Madrid, Spain, 28670
- Universidad Europea de Madrid
-
Contact:
- Sara Vilas, Ph.D.
- Email: sarapaloma.vilas@universidadeuropea.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ACT group
8 individual weekly sessions which included ACT methods
|
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
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
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
Sponsor
Investigators
- Principal Investigator: Francisco Montesinos, Ph.D., Universidad Europea de Madrid
- Principal Investigator: David Lobato, Ph.D., Universidad Europea de Madrid
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIm25/04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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