Group-Based Acceptance and Commitment Therapy Versus Active Control in University Students With Emotional Symptoms

Официальное название

Efficacy of a Group-Based Acceptance and Commitment Therapy Protocol Compared to an Active Control in University Students With Emotional Symptoms: a Randomized Controlled Trial With an Ideographic Approach

Обзор

This study evaluates the efficacy of a group-based Acceptance and Commitment Therapy (ACT) protocol compared to a non-directive group therapy used as an active control condition in university students presenting moderate to moderate/high levels of emotional symptomatology. Emotional difficulties such as depressive and anxiety symptoms are highly prevalent among university students and may negatively affect academic performance, well-being, and long-term functioning. Acceptance and Commitment Therapy (ACT) is an evidence-based psychological intervention that aims to improve mental health by increasing psychological flexibility, the ability to act in accordance with personal values while remaining open to difficult internal experiences. Participants will be randomly assigned to either (1) a structured ACT group intervention or (2) a non-directive supportive group intervention that controls for therapeutic attention and group support factors. The primary hypothesis is that participants receiving ACT will show greater reductions in emotional symptoms and greater improvements in psychological flexibility compared to the active control group. Outcomes will include depressive and anxiety symptoms, psychological flexibility, repetitive negative thinking, and meaning in life. The study uses a multimethod assessment strategy combining traditional self-report questionnaires administered at baseline, post-intervention, and follow-up; Ecological Momentary Assessment (EMA) with daily and weekly measures during the intervention period; and qualitative interviews to explore participants' experiences.

Вмешательства

• Поведенческое Acceptance and Commitment Therapy (ACT)
  Manualized brief group intervention delivered in five in-person 90-minute sessions. The objective is to increase psychological flexibility through the core processes of the ACT model.
• Поведенческое Non-Directive Group Therapy (NDT)
  Group-based non-directive intervention delivered in five in-person 90-minute sessions. It offers validation and supportive interaction, replicating common psychotherapy factors such as empathy and active listening, without including specific clinical techniques.

Первичные конечные точки

• Change in emotional symptoms measured by the Patient Health Questionnaire-4 (PHQ-4) [Срок оценки: Daily and weekly assessments from Week 2 to Week 15; follow-up at Weeks 15 and 23]

Вторичные конечные точки (5)

• Change in psychological flexibility and inflexibility measured by the Flexible and Inflexible Behavior Questionnaire (CCFI) [Срок оценки: Daily and Weekly assessments from Week 2 to Week 15; follow-up at Weeks 15 and 23]
• Change in repetitive negative thinking measured by the Repetitive Negative Thinking Questionnaire-3 (RNT-3) [Срок оценки: Daily and weekly assessments from Week 2 to Week 15; follow-up at Weeks 15 and 23]
• Change in anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7 total score) [Срок оценки: Baseline (Week 1), after eligibility was confirmed (Week 2), post-treatment (Week 11), and follow-up at 4 and 12 weeks post-intervention (Weeks 15 and 23)]
• Change in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9 total score) [Срок оценки: Baseline (Week 1), after eligibility was confirmed (Week 2), post-treatment (Week 11), and follow-up at 4 and 12 weeks post-intervention (Weeks 15 and 23)]
• Change in sense of purpose in life measured by the Purpose in Life Test (PIL-Test total score) [Срок оценки: After eligibility was confirmed (Week 2), post-treatment (Week 11), and follow-up at 4 and 12 weeks post-intervention (Weeks 15 and 23).]

Критерии участия

Критерии включения

• University students aged 18 to 28 years.
• Score ≥8 on the PHQ-9.
• Score ≥8 on the GAD-7.
• Willingness to participate in a longitudinal study including pre-, post-, and follow-up assessments.
• Willingness to complete daily and weekly ecological momentary assessments (EMA).
• Provision of written informed consent.

Критерии исключения

• Suicide risk based on clinical indicators derived from PHQ-9 assessment.
• Self-reported history of psychotic disorders.
• Self-reported problematic substance use.
• Failure to provide informed consent.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Uruguay · 1 центр

• Universidad de Montevideo — Montevideo

Идентификаторы

NCT: NCT07506148 · CE2025/37

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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