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AnxietyACTNCT07813520

Effect of an ACT-based Intervention to Reduce Anxiety in Medical Students

A study testing ACT_based intervention in people with Anxiety and Somatization, run by University of Guadalajara at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: To evaluate the association between ACT-process with negative psychological variables in a cross-sectional design, and to evaluate the effect of an ACT-based intervention to diminish anxiety in a sample of medical students. Read more about this study

Who is it for?
Ages 18 to 26 years
Conditions the study is for
Anxiety, Somatization, Depressive Symptom
What is being tested?
ACT_based intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
1 siteMexico
Study dates
5 Aug 2024to 14 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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 26 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult medical students at the Health Sciences University Center of the University of Guadalajara
  • who were studying from first to third semesters were invited to participate.

Who cannot join

  • students that were participating in other psychological of intervention program
  • students that did not complete all the sessions of the intervention.

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • University of Guadalajara, Health Sciences University Center

    Guadalajara, Jalisco, 44340

Other trials in Mexico

About this study

Official title: "Effect of an Intervention Based in Acceptance and Commitment Therapy (ACT) to Increase Psychological Flexibility and Reduce Anxiety in Medical Students of the Health Sciences University Center"

Objective: To evaluate the association between ACT-process with negative psychological variables in a cross-sectional design, and to evaluate the effect of an ACT-based intervention to diminish anxiety in a sample of medical students.

Methods: An ACT-based intervention was designed to diminish anxiety in medical students and implemented in 4 in-person sessions, the pre-test and post-test measurements were performed one week before and one week after the first and last sessions respectively. The control group received a mental health psychoeducational intervention of 90 minutes. The students were intentionally assigned to each study group based on schedule availability. The cross-sectional study was performed with the pre-test measurements in the students of both groups.<

Read the detailed description

Here we detail the methodology employed:

PARTICIPANTS AND METHODS Ethics The study was performed according to the Declaration of Helsinki. The protocol was approved by the Research and Ethics Committees of CUCS of the University of Guadalajara with the approval number CI-03023. All participants signed an informed consent form prior to enrollment. The interventions were delivered by health professionals trained in ACT.

Participants Adult medical students at the Health Sciences University Center of the University of Guadalajara who were studying from first to third semesters were invited to participate. The exclusion criteria were a) students that were participating in other psychological of intervention program, and b) students that did not complete all the sessions of the intervention.

Study period: The study was performed in two time points, one in 2023 and the second in 2025, in these two time points the intervention was performed to different participants by different instructors, finally the analyses were conducted with the combined sample.

Measurements Variables: The following variables were measured: psychological flexibility, assessed through four instruments corresponding to ACT-specific processes: the Acceptance and Action Questionnaire-II (AAQ-II) (Espinosa et al., 2010), range 1 - 7, measuring experiential avoidance; the Cognitive Fusion Questionnaire (CFQ) (Ruiz et al., 2017), range 1 - 7, measuring cognitive fusion; the Mindful Attention Awareness Scale (MAAS) (López-Maya, 2015), range 1 - 6, measuring mindfulness, and the Valuing Questionnaire (VQ), (Ruiz et al., 2021), range 0 - 6, measuring consistency with personal values. Negative psychological variables included anxiety, measured with the Generalized Anxiety Disorder scale (GAD-7), range 0 - 3, (Spitzer \& Kroenke, 2006; García-Campallo et al., 2010), depression, measured with the Patient Health Questionnaire-9 (PHQ-9), (Kroenke et al., 2001; Baader et al., 2012), range 0 - 3, somatization, measured with the Patient Health Questionnaire-15 (PHQ-15) (Ros-Montalbán et al., 2010), range 0 - 2, and stress, measured with the Perceived Stress Scale (PSS-14) (Cohen et al., 2010; Remor et al., 2006), range 0 - 4. Sleep satisfaction was assessed with the first item of the Oviedo Sleep Questionnaire (Bobes-García et al., 2000), range 1 to 7.

Sociodemographic and personal variables including age, sex, semester, relationship status (yes, no), socioeconomic level, measured as low, medium and high, alcohol and smoking consumption frequency (from never to 4 or more times in the week), daily minutes of physical activity, daily hours of free time, employment status (yes, no), history of psychological treatment (yes, no), and the number of self-reported health condition (21 different conditions including anxiety, depression, skin diseases, overweight, migraine, colitis, gastritis, allergies, gastrointestinal or respiratory infections, sinusitis, thyroid problems, hypertension, anorexia/bulimia, high cholesterol, renal problems, diabetes, rheumatic conditions, cardiac diseases, cerebral stroke and cancer). The presence of suicide ideation and suicide behavior were measured with the questions: "have you had thoughts of taking your own life?" and "have you taken any actions to try to take your own life?", respectively (answer options, yes, no). All these variables were collected via a Google Forms questionnaire.

Study 1. Design: Study one consisted in a cross-sectional design aimed in determining the correlation among the ACT-related variables with anxiety, depression and stress.

Participants: The participants were those who complied the selection criteria previously described.

Variables: The variables previously described and measured in the pre-test of the intervention program were included for this analysis.

Study 2. Design: This is a cuasi-experimental design with a pre-test and post-test measurements and a control group (psychoeducational session).

Participants: The students were directly invited in their classrooms to either of the 2 interventions in order to facilitate their participation in one schedule, those who accepted to participate were summoned at the University facilities in a schedule convenient for them and the instructor, to receive either the intervention program or the psychoeducational session on mental health.

Procedures: The experimental group received four weekly in-person group sessions based on ACT, conducted at the university facilities. The sessions addressed the six core processes of ACT (acceptance, cognitive defusion, being present, self as context, values, and committed action), with the therapeutic content oriented toward anxiety management. Session duration was 90 to 120 minutes. The sessions program is described in Table 1. The control group received a single psychoeducational session on mental health (90 minutes duration), which included a brief explanation of some techniques for anxiety regulation.

Variables: The previously mentioned variables were measured one week before intervention and 1 week after the final session. Measurements in the control group were conducted at the same time points as those in the intervention group. All measurements were performed via a google form questionnaire.

Table 1. Session program implemented in the intervention group Session number Objective General procedure

  1. - Acceptance To facilitate the development of acceptance regarding unpleasant internal experiences (thoughts, emotions and physical sensations related with anxiety) a) Welcome b) Brief explanation of the specific process of ACT. c) Mindfulness exercise d) Exercise with metaphors related with the specific ACT process. e) Reinforce the process in daily life and give the participants related exercises as homework.
  2. - Defusion and contact with the present moment. To reduce the impact of thoughts in anxiety or psychological distress by developing skills for cognitive defusion, by observing thoughts without becoming entangled in them, and conscious contact with the present moment.
  3. - Me as a context and living values To foster a flexible perspective of the self (self as a context) and clarify personal values as compass for behavior, regardless of the presence of difficult internal experiences.
  4. - Committed action Promote the execution of behaviors aligned with personal values, even in the presence of anxiety or psychological distress, thereby consolidating what was learned in previous sessions.

ACT: Acceptance and commitment therapy. Statistical analysis Descriptive statistics were obtained with means and standard deviations for quantitative variables with parametric distributions and with median and interquartile range for quantitative variables with non-parametric distributions. For qualitative variables frequencies and percentages were obtained. To perform the description of negative psychological variables including anxiety, depression, stress and somatization we obtained 4 to 5 categories (from low to severe) by dividing the possible range of each variable in the number of categories, the categories were determined according to the original instrument recommendations. To evaluate the instrument reliability of all psychological variables, the Cronbach alpha test was performed.

Study 1: Associations between ACT-specific variables, sociodemographic variables, and negative psychological variables were analyzed using Pearson's and Spearman's correlation tests depending on the data distribution. To determine the variables most associated with anxiety we performed a multivariate regression analysis using the stepwise method and including all the studied variables (dichotomous, quantitative and ordinals) as independent variable and excluding suicide ideation, suicide behavior and the negative psychological variables (depression, stress and somatization), this last by considering that these variables would not add information as effective predictors and possible objectives to reduce anxiety.

Study 2: To compare quantitative variables between groups at baseline, the student's t-test or Mann-Whitney U test was applied for parametric and non-parametric distributions, respectively, and the chi-squared test or Fisher's exact test was used for qualitative variables. To evaluate the effect of the intervention, the difference in each variable (posttest minus pretest) was compared between the experimental and control groups using the student's t-test or Mann-Whitney U test. Effect sizes were calculated using Cohen's D test. All analyses were conducted with SPSS software 31 and JASP program (JASP version 0.95.2) (JASP, 2025).

Being tested
ACT_based intervention, Active Control group
Keywords
psychological intervention
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACT_based interventionBehavioural

    Session number Objective General procedure

    1. - Acceptance To facilitate the development of acceptance regarding unpleasant internal experiences (thoughts, emotions and physical sensations related with anxiety)
    2. - Defusion and contact with the present moment. To reduce the impact of thoughts in anxiety or psychological distress by developing skills for cognitive defusion, by observing thoughts without becoming entangled in them, and conscious contact with the present moment.
    3. - Me as a context and living values To foster a flexible perspective of the self (self as a context) and clarify personal values as compass for behavior, regardless of the presence of difficult internal experiences
    4. - Committed action: promote execution of behaviors aligned with personal values
  • Active Control groupBehavioural

    This group received a 90-minutes psychoeducational session about mental health including a brief explanation of what anxiety is, its risk factors and symptoms and techniques for anxiety regulation including the psychological interventions as Behavioral therapy, acceptance and commitment therapy and mindfulness, and the description of conductual changes that can reduce anxiety.

Study groups in NCT07813520
Study groupRoleWhat they receive
ACT_based interventionExperimentalThis arm was assigned to the ACT_based therapy, which consisted in 4 weekly sessions of 2 hours, including information about: : Session number Objective General procedure 1.- Acceptance To facilitate the development of acceptance regarding unpleasant internal experiences (thoughts, emotions and physical sensations related with anxiety) 2.- Defusion and contact with the present moment. To reduce the impact of thoughts in anxiety or psychological distress by developing skills for cognitive defusion, by observing thoughts without becoming entangled in them, and conscious contact with the present moment. 3.- Me as a context and living values To foster a flexible perspective of the self (self as a context) and clarify personal values as compass for behavior, regardless of the presence of difficult internal experiences 4.- Committed action: promote execution of behaviors aligned with personal values
Receives: Behavioral: ACT_based intervention
Active control groupActive comparatorThis group was assigned to an active computation group which consisted in a single psychoeducational 90 minutes session about mental health, which included the explanation of techniques to diminish anxiety
Receives: Behavioral: Active Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety symptos

    This measure was performed with the General Anxiety Disease (GAD-7) questionnaire.

    Measured: From enrollment to the end of the study after 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start5 Aug 2024
  3. Primary completion14 Dec 2025
  4. Study completion14 Dec 2025

Resources

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
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07813520
Sponsor's protocol ID
CI-03023
Acronym
ACT
Status last verified
Sep 2026
First submitted
4 Sep 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We do not plan to share IPD, as the according to the local ethics committee, we are not allowed to share this information being considered confidential

Questions about this trial

What is this clinical trial studying?

A study testing ACT_based intervention in people with Anxiety and Somatization, run by University of Guadalajara at 1 site in Mexico.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 10 Sep 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 Mexico. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety symptos (time frame: From enrollment to the end of the study after 4 weeks). 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 10 Sep 2026.

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ACT Clinical Trial NCT07813520 | AzTrials