NCT07066488

Brief 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? 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

July 4, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

July 4, 2025

Last Update Submit

July 4, 2025

Conditions

Problem Gambling

Keywords

Problem GamblingGaming DisorderPsychological Inflexibility

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Change in Difficulties in Emotion Regulation Scale (DERS-28)

    Change from Baseline emotion regulation at 8 months

  • Change in General Health Questionnaire (GHQ-12)

    Change from Baseline psychological distress and perceived general health at 8 months

  • Change in the Comprehensive ACT Process Assessment Questionnaire (CompACT)

    Change from Baseline psychological flexibility at 8 months

  • Change in Values Living Questionnaire (VLQ)

    Change from Baseline value-behavior alignment at 8 months

  • Change in Gambling-Related Emotional Distress Scale

    Change from Baseline gambling-related distress at 8 months

  • +3 more secondary outcomes

Study Arms (1)

ACT group

EXPERIMENTAL

8 group weekly sessions including ACT methods

Behavioral: Acceptance and Commitment Therapy (ACT)

Interventions

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.

ACT group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

Location

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Francisco Montesinos, Ph.D.

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

  • David Lobato, Ph.D.

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco Montesinos, Ph.D.

CONTACT

+34647143773francisco.montesinos@universidadeuropea.es

Ruben Perez

CONTACT

+34686822991ruben.perez@universidadeuropea.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2025

First Posted

July 15, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)