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NCT Number: NCT07506148

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

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Montevideo

Montevideo, Montevideo Department, 11600, Uruguay

Location status: Recruiting

Location contact

Monica Larrosa, M.A

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in emotional symptoms measured by the Patient Health Questionnaire-4 (PHQ-4)

    Time frame: 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.

Secondary outcomes

  1. Change in psychological flexibility and inflexibility measured by the Flexible and Inflexible Behavior Questionnaire (CCFI)

    Time frame: Daily and Weekly assessments from Week 2 to Week 15; follow-up at Weeks 15 and 23

    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.

  2. Change in repetitive negative thinking measured by the Repetitive Negative Thinking Questionnaire-3 (RNT-3)

    Time frame: Daily and weekly assessments from Week 2 to Week 15; follow-up at Weeks 15 and 23

    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.

  3. Change in anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7 total score)

    Time frame: 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)

    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.

  4. Change in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9 total score)

    Time frame: 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)

    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.

  5. Change in sense of purpose in life measured by the Purpose in Life Test (PIL-Test total score)

    Time frame: After eligibility was confirmed (Week 2), post-treatment (Week 11), and follow-up at 4 and 12 weeks post-intervention (Weeks 15 and 23).

    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.

Other outcomes

  1. Perceived change and intervention acceptability

    Time frame: Post-treatment (Week 11)

    Semi-structured interviews conducted by blinded evaluators to explore subjective experiences, perceived psychological change, and acceptability of the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Mónica Larrosa Signorelli, Lic. Psic., Mgtr.

CONTACT

[email protected]

+598 99 705 437

Sponsors and collaborators

Lead sponsor

Mónica Larrosa Signorelli

Other

Registry information

Official study 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

Acronym: ACT-EMA-RCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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