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

NCT07506148 | Recruiting

• 1 other identifier: CE2025/37
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Anxiety

Keywords

Acceptance and Commitment Therapy; psychological flexibility; repetitive negative thinking; ecological momentary assessment; university students

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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).

Other Outcomes (1)

• Perceived change and intervention acceptability

  Post-treatment (Week 11)

Study Arms (2)

Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

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)

Non-Directive Group Therapy (NDT)

ACTIVE COMPARATOR

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)

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

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.

Acceptance and Commitment Therapy (ACT)

Non-Directive Group Therapy (NDT) BEHAVIORAL

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.

Non-Directive Group Therapy (NDT)

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mónica Larrosa Signorelli: lead

Study Sites (1)

Universidad de Montevideo

Montevideo, Montevideo Department, 11600, Uruguay

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Mónica Larrosa Signorelli, Lic. Psic., Mgtr.

CONTACT

+598 99 705 437; m.larrosa@um.edu.uy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Bachelor's Program in Psychology at Universidad de Montevideo

Model Details: Randomized parallel-group clinical trial with two active conditions: Acceptance and Commitment Therapy (ACT) versus non-directive group therapy (NDT) as an active control. Participants with baseline severity (PHQ-9/GAD-7) will be individually randomized (1:1 allocation). ACT groups and NDT groups will run in parallel (approximately 5-10 participants per group). Assessments will be conducted daily and weekly, and at four time points (pre-treatment, after eligibility was confirmed, post-treatment, 1-month follow-up, and 3-month follow-up). Daily measures will consist of ecological momentary assessments (EMA) and weekly measures. The primary outcomes will be the emotional symptoms evaluated daily and weekly. Analyses will follow the intention-to-treat principle using mixed-effects models.

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: April 1, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• 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.

Locations

UR (1)