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Набор скоро начнётся NCT07066501

ACT-Based Intervention for Problem Gambling

Без фазы С лечением Problem Gambling

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Acceptance and Commitment Therapy (ACT).
Кому может быть актуально
Состояния в реестре: Problem Gambling. Базовые параметры: 18 лет — 25 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
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Официальное название

Efficacy of a Group Intervention Grounded in Acceptance and Commitment Therapy (ACT) to Address Problem Gambling in Youth: A Randomized Clinical Trial

Обзор

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

Подробное описание

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.

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

  • Change in Problem Gambling Severity Index (PGSI) [Срок оценки: Change from Baseline severity of problem gambling at 8 months]
Вторичные конечные точки (8)
  • Change in Difficulties in Emotion Regulation Scale (DERS-28) [Срок оценки: Change from Baseline emotion regulation at 8 months]
  • Change in General Health Questionnaire (GHQ-12) [Срок оценки: Change from Baseline psychological distress and perceived general health at 8 months]
  • Change in the Comprehensive ACT Process Assessment Questionnaire (CompACT) [Срок оценки: Change from Baseline psychological flexibility at 8 months]
  • Change in Values Living Questionnaire (VLQ) [Срок оценки: Change from Baseline value-behavior alignment at 8 months]
  • Change in Gambling-Related Emotional Distress Scale [Срок оценки: Change from Baseline gambling-related distress at 8 months]
  • Change in Gambling-Related Experiential Avoidance scale [Срок оценки: Change from Baseline Experiential Avoidance at 8 months]
  • Change in the frequency of self-reported gambling behaviors [Срок оценки: Change from Baseline gambling behaviors at 8 months]
  • Change in the frequency of committed actions [Срок оценки: Change from Baseline committed actions at 8 months]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Universidad Europea de Madrid — Villaviciosa de Odón

Идентификаторы

NCT: NCT07066501 · CEIm25/04

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗