An interventional study of Acceptance and Commitment Therapy (ACT) and Non-Directive Group Therapy (NDT) in Depression and Anxiety, sponsored by Mónica Larrosa Signorelli. Recruiting at 1 site in Uruguay. Open to participants aged 18 Years to 28 Years. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Mónica Larrosa Signorelli · Not applicable, Interventional, and Treatment
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 48 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with Mónica Larrosa Signorelli as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
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.
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.
Time frame: Daily and weekly assessments from Week 2 to Week 15; follow-up at Weeks 15 and 23
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.
Time frame: 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.
Time frame: 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.
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)
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.
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)
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.
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).
Perceived change and intervention acceptability
Semi-structured interviews conducted by blinded evaluators to explore subjective experiences, perceived psychological change, and acceptability of the intervention.
Time frame: Post-treatment (Week 11)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
Started Mar 2026 (actual). Primary completion is estimated for Jul 2026, 4 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 4 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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