ACT-Based Intervention for Problem Gambling

NCT07066501 | Not Yet Recruiting

• 1 other identifier: CEIm25/04
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Problem Gambling

Keywords

Problem Gambling; Gaming Disorder; Psychological 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

Study Arms (2)

ACT group

EXPERIMENTAL

8 individual weekly sessions which included ACT methods

Behavioral: Acceptance and Commitment Therapy (ACT)

Waiting list

NO INTERVENTION

Participants assigned to Waiting List arm waited for 2 months before receiving treatment

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

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

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 Therapy; Behavior Therapy; Psychotherapy; Behavioral 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

647143773; francisco.montesinos@universidadeuropea.es

Ruben Perez

CONTACT

+34686822991; ruben.perez@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization assigned participants to 2 arms: * ACT group * Waiting list

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 15, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)