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

NCT07506148 · Universidad de Montevideo
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Official title
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
About this study
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.
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Study design
Enrollment target: 48 participants
Allocation: randomized
Masking: double
Age groups: adult
Timeline
Starts: 2026-03-20
Estimated completion: 2026-12
Last updated: 2026-04-01
Interventions
Behavioral: Acceptance and Commitment Therapy (ACT)Behavioral: Non-Directive Group Therapy (NDT)
Primary outcomes
  • Change in emotional symptoms measured by the Patient Health Questionnaire-4 (PHQ-4) (Daily and weekly assessments from Week 2 to Week 15; follow-up at Weeks 15 and 23)
Sponsor
Mónica Larrosa Signorelli · other
Contacts & investigators
ContactMónica Larrosa Signorelli, Lic. Psic., Mgtr. · contact · m.larrosa@um.edu.uy · +598 99 705 437
All locations (1)
Universidad de MontevideoRecruiting
Montevideo, Montevideo Department, Uruguay
Group-Based Acceptance and Commitment Therapy Versus Active Control in University Students With Emotional Symptoms · TrialPath