Group-Based Acceptance and Commitment Therapy Versus Active Control in University Students With Emotional Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-28
SponsorMónica Larrosa Signorelli
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Acceptance and Commitment Therapy (ACT)
BehavioralManualized 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)
BehavioralGroup-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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Acceptance and Commitment Therapy (ACT)Experimental treatment 1 intervention
Group B: Non-Directive Group Therapy (NDT)Active comparator 1 intervention
Trial outcomes
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.
Time frame
Daily and weekly assessments from Week 2 to Week 15; follow-up at Weeks 15 and 23Secondary outcomes
1
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 232
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 233
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)4
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)Other outcomes
1
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mónica Larrosa Signorelli
Lead sponsor
Universidad de Montevideo
Sponsor institution
Source ClinicalTrials.gov