Problem GamblingNCT07066488
Brief ACT Intervention for Problem Gambling: A Pilot Study
A study testing Acceptance and Commitment Therapy (ACT) in people with Problem Gambling, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
The goal of this pilot study is to learn if Acceptance and Commitment Therapy (ACT) works to treat Problem Gambling in young adults.The main questions it aims to answer are: Does ACT therapy improve health and gambling behavior? Is an 8-week online group therapy format viable for youth with gambling problems?… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Problem Gambling
- What is being tested?
- Acceptance and Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 25 years
- Score ≥ 3 on the Problem Gambling Severity Index (PGSI)
- Comprehension of Spanish, online connection, and signed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universidad Europea de Madrid
Villaviciosa de Odón, Madrid, 28670
Sara Vilas, Ph.D., sarapaloma.vilas@universidadeuropea.es
About this study
Official title: Brief Group Intervention Based on Acceptance and Commitment Therapy (ACT) for Problem Gambling: A Pilot Study
The goal of this pilot study is to learn if Acceptance and Commitment Therapy (ACT) works to treat Problem Gambling in young adults.The main questions it aims to answer are:
- Does ACT therapy improve health and gambling behavior?
- Is an 8-week online group therapy format viable for youth with gambling problems? Researchers will assess whether changes in health, gambling behavior, and other psychological variables are observed after eight weeks of therapy.
Read more
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
Read the 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 pilot study will not include a control group.
- Conditions
- Problem Gambling
- Being tested
- Acceptance and Commitment Therapy (ACT)
- Keywords
- Problem Gambling, Gaming Disorder, Psychological Inflexibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACT group | Experimental | 8 group weekly sessions including ACT methods Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline severity of problem gambling at 8 months
Secondary outcomes (8)
Change in Difficulties in Emotion Regulation Scale (DERS-28)
The 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline committed actions at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem GamblingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco Montesinos, Ph.D., Principal investigator, Universidad Europea de MadridDavid Lobato, Ph.D., Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066488
- Sponsor's protocol ID
- 2025-81
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Group Intervention Based on Acceptance and Commitment Therapy (ACT) for Problem Gambling: A Pilot Study
- ClinicalTrials.gov ID
- NCT07066488
- Acronym / sponsor ID
- 2025-81
- Conditions
- Problem Gambling
- Keywords
- Problem Gambling, Gaming Disorder, Psychological Inflexibility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to learn if Acceptance and Commitment Therapy (ACT) works to treat Problem Gambling in young adults.The main questions it aims to answer are:
- Does ACT therapy improve health and gambling behavior?
- Is an 8-week online group therapy format viable for youth with gambling problems? 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
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 pilot study will not include a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACT group | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)8 group weekly sessions including ACT methods |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 25 years
- Score ≥ 3 on the Problem Gambling Severity Index (PGSI)
- Comprehension of Spanish, online connection, and signed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ACT group |
Primary outcome
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.
8 secondary outcomes
Change in Difficulties in Emotion Regulation Scale (DERS-28)
Time frame: 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
Change in the Comprehensive ACT Process Assessment Questionnaire (CompACT)
Time frame: 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
Change in Gambling-Related Emotional Distress Scale
Time frame: 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
Change in the frequency of self-reported gambling behaviors
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francisco Montesinos, Ph.D. principal investigator
Universidad Europea de Madrid
David Lobato, Ph.D. principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) in people with Problem Gambling, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Montesinos, Ph.D. (+34647143773, francisco.montesinos@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Problem Gambling Severity Index (PGSI) (time frame: Change from Baseline severity of problem gambling at 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.