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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in emotional symptoms measured by the Patient Health Questionnaire-4 (PHQ-4)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcome assessors and data analysts will remain blinded to treatment allocation. Participants and therapists cannot be blinded due to the nature of the psychological interventions. Allocation codes will be concealed until completion of primary analyses.
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •University students aged 18 to 28 years.
- •Score ≥8 on the PHQ-
- •Score ≥8 on the GAD-
- •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.
排除标准
- •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.
结局指标
主要结局
Change in emotional symptoms measured by the Patient Health Questionnaire-4 (PHQ-4)
时间窗: Daily and weekly assessments from Week 2 to Week 15; follow-up at Weeks 15 and 23
The Patient Health Questionnaire-4 (PHQ-4) is a 4-item self-report scale assessing anxiety and depressive symptoms, with total scores ranging from 0 to 12. Higher scores indicate greater emotional symptom severity.
次要结局
- Change in psychological flexibility and inflexibility measured by the Flexible and Inflexible Behavior Questionnaire (CCFI)(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)(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)(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)(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)(After eligibility was confirmed (Week 2), post-treatment (Week 11), and follow-up at 4 and 12 weeks post-intervention (Weeks 15 and 23).)
研究者
Mónica Larrosa Signorelli
Director of the Bachelor's Program in Psychology at Universidad de Montevideo
Universidad de Montevideo