Anxiety, Depression
Conditions
Keywords
Acceptance and Commitment Therapy, psychological flexibility, repetitive negative thinking, ecological momentary assessment, university students
Brief 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. 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.
Interventions
BEHAVIORALAcceptance 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.
BEHAVIORALNon-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.
Sponsors
Mónica Larrosa Signorelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 28 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in emotional symptoms measured by the Patient Health Questionnaire-4 (PHQ-4) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in psychological flexibility and inflexibility measured by the Flexible and Inflexible Behavior Questionnaire (CCFI) | 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. |
| Change in repetitive negative thinking measured by the Repetitive Negative Thinking Questionnaire-3 (RNT-3) | 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. |
| Change in anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7 total score) | 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. |
| Change in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9 total score) | 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. |
| Change in sense of purpose in life measured by the Purpose in Life Test (PIL-Test total score) | 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. |
Countries
Uruguay
Contacts
CONTACTMónica Larrosa Signorelli, Lic. Psic., Mgtr.
Outcome results
None listed