Group-Based Acceptance and Commitment Therapy Versus Active Control in University Students With Emotional Symptoms (ACT-EMA-RCT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Non-Directive Group Therapy (NDT)

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mónica Larrosa Signorelli, Lic. Psic., Mgtr.; Phone Number: +598 99 705 437; Email: m.larrosa@um.edu.uy

Study Locations

• Uruguay
  • Montevideo Department
    • Montevideo, Montevideo Department, Uruguay, 11600
      • Recruiting
      • Universidad de Montevideo
      • Contact: Monica Larrosa, M.A

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance and Commitment Therapy (ACT); Manualized brief group intervention based on Acceptance and Commitment Therapy (ACT), delivered in five in-person sessions of approximately 90 minutes each (detailed in appendices). The intervention aims to increase psychological flexibility through the core processes of the ACT model.	Behavioral: 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.
Active Comparator: Non-Directive Group Therapy (NDT); Group-based non-directive therapy of equal length and format to ACT (five 90-minute in-person sessions; detailed in appendices). The intervention provides a space for validation and support, replicating common psychotherapy factors such as empathy and active listening, without including specific clinical intervention techniques.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in emotional symptoms measured by the Patient Health Questionnaire-4 (PHQ-4)	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.	Daily and weekly assessments from Week 2 to Week 15; follow-up at Weeks 15 and 23

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in psychological flexibility and inflexibility measured by the Flexible and Inflexible Behavior Questionnaire (CCFI)	The Flexible and Inflexible Behavior Questionnaire (CCFI) assesses patterns of flexible and inflexible behavior using items rated on a Likert scale from 0 to 6. Total scores are computed, with higher scores on the inflexibility dimension indicating greater psychological inflexibility, and higher scores on the flexibility dimension indicating greater psychological flexibility.	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)	The Repetitive Negative Thinking Questionnaire-3 (RNT-3) is a 3-item self-report scale assessing repetitive negative thinking (rumination and worry), with each item rated from 0 to 4. Total scores range from 0 to 12, with higher scores indicating greater repetitive negative thinking.	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)	The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report scale assessing anxiety symptoms, with total scores ranging from 0 to 21, where 0 indicates no anxiety symptoms and 21 indicates the highest level of anxiety symptom severity. Higher scores indicate worse anxiety symptoms.	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)	The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report scale assessing depressive symptoms, with total scores ranging from 0 to 27, where 0 indicates no depressive symptoms and 27 indicates the highest level of depressive symptom severity. Higher scores indicate worse depressive symptoms.	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)	The Purpose in Life Test (PIL-Test) is a 20-item self-report scale assessing meaning and purpose in life, with each item scored from 1 to 7 and total scores ranging from 20 to 140, where 20 indicates the lowest sense of purpose in life and 140 indicates the highest sense of purpose in life. Higher scores indicate a better outcome, that is, greater sense of purpose in life.	After eligibility was confirmed (Week 2), post-treatment (Week 11), and follow-up at 4 and 12 weeks post-intervention (Weeks 15 and 23).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived change and intervention acceptability	Semi-structured interviews conducted by blinded evaluators to explore subjective experiences, perceived psychological change, and acceptability of the intervention.	Post-treatment (Week 11)

Collaborators and Investigators

• Sponsor: Mónica Larrosa Signorelli

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 21, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; university students; ecological momentary assessment; psychological flexibility; repetitive negative thinking
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy
• Other Study ID Numbers: CE2025/37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) underlying the results reported in publications will be shared. This includes coded sociodemographic variables and scores from the psychometric instruments used in the study. No direct identifiers or information that could reasonably lead to participant re-identification will be shared.
• IPD Sharing Time Frame: IPD will be available beginning 6 months after publication of the primary results and will remain available for a period of 5 years.
• IPD Sharing Access Criteria: IPD will be available to qualified academic researchers who submit a methodologically sound proposal and provide documentation of ethics approval, where applicable. Requests must be submitted to the Principal Investigator via email. Access will require signing a Data Use Agreement ensuring confidentiality and use solely for scientific research purposes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No