DepressionACT-EMA-RCTNCT07506148
Group-Based Acceptance and Commitment Therapy Versus Active Control in University Students With Emotional Symptoms
A study testing Acceptance and Commitment Therapy (ACT) and Non-Directive Group Therapy (NDT) in people with Depression and Anxiety, run by Mónica Larrosa Signorelli at 1 site in Uruguay.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Acceptance and Commitment Therapy (ACT) and Non-Directive Group Therapy (NDT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUruguay
- Study dates
- 20 Mar 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uruguay1 site, 1 recruiting
- Recruiting
Universidad de Montevideo
Montevideo, Montevideo Department, 11600
Monica Larrosa, M.A
About this study
Official 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
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.
Read more
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
- Being tested
- Acceptance and Commitment Therapy (ACT), Non-Directive Group Therapy (NDT)
- Keywords
- Acceptance and Commitment Therapy, psychological flexibility, repetitive negative thinking, ecological momentary assessment, university students
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Non-Directive Group Therapy (NDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After eligibility was confirmed (Week 2), post-treatment (Week 11), and follow-up at 4 and 12 weeks post-intervention (Weeks 15 and 23).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start20 Mar 2026
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mónica Larrosa Signorelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mónica Larrosa Signorelli, Universidad de Montevideo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506148
- Sponsor's protocol ID
- CE2025/37
- Acronym
- ACT-EMA-RCT
- Status last verified
- Feb 2026
- First submitted
- 21 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07506148
- Acronym / sponsor ID
- ACT-EMA-RCT / CE2025/37
- Conditions
- Depression, Anxiety
- Keywords
- Acceptance and Commitment Therapy, psychological flexibility, repetitive negative thinking, ecological momentary assessment, university students
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mónica Larrosa SignorelliUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | Behavioral: 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. |
| Non-Directive Group Therapy (NDT) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Acceptance and Commitment Therapy (ACT) |
| 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. | Behavioural | Non-Directive Group Therapy (NDT) |
Primary outcome
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.
5 secondary outcomes
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
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
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)
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)
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) and Non-Directive Group Therapy (NDT) in people with Depression and Anxiety, run by Mónica Larrosa Signorelli at 1 site in Uruguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mónica Larrosa Signorelli, Lic. Psic., Mgtr. (+598 99 705 437, m.larrosa@um.edu.uy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.