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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mónica Larrosa Signorelli, Lic. Psic., Mgtr. | Contact | +598 99 705 437 | m.larrosa@um.edu.uy |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Montevideo | Recruiting | Montevideo | Montevideo Department | 11600 | Uruguay |
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 will be available beginning 6 months after publication of the primary results and will remain available for a period of 5 years.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2026 | Mar 27, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 27, 2026 | Mar 27, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Eligibility criteria | Mar 27, 2026 | Mar 27, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Main Experiment | Mar 27, 2026 | Mar 27, 2026 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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.
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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.
| 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. |
|
| 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). |