Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Researchers will assess whether changes in health, gambling behavior, and other psychological variables are observed after eight weeks of therapy.
Participants will:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT group | Experimental | 8 individual weekly sessions which included ACT methods |
|
| Waiting list | No Intervention | Participants assigned to Waiting List arm waited for 2 months before receiving treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Problem Gambling Severity Index (PGSI) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Difficulties in Emotion Regulation Scale (DERS-28) | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francisco Montesinos, Ph.D. | Contact | 647143773 | francisco.montesinos@universidadeuropea.es | |
| Ruben Perez | Contact | +34686822991 | ruben.perez@universidadeuropea.es |
| Name | Affiliation | Role |
|---|---|---|
| Francisco Montesinos, Ph.D. | Universidad Europea de Madrid | Principal Investigator |
| David Lobato, Ph.D. | Universidad Europea de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Europea de Madrid | Villaviciosa de Odón | Madrid | 28670 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2025 | Jul 3, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 23, 2025 | Jul 3, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Randomization assigned participants to 2 arms:
Not provided
Not provided
Not provided
|
| Change from Baseline emotion regulation at 8 months |
| Change in General Health Questionnaire (GHQ-12) | 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) | 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) | 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 | 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 | 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 | 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 | 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 |