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NCT Number: NCT07776236

Remote Group Cognitive Behavioral Skills Training for Mexican University Students With Anxiety or Depression

The aim is to assess the effectiveness of remote group cognitive behavioral skills training for reducing symptoms of depression and anxiety among university students in Mexico. The investigators will conduct a two-arm randomised control trial comparing a 10-session online group CBT intervention to a mood monitoring web-based application as an active control group.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

What is this study about? Many university students in Mexico struggle with anxiety and depression, but most never receive treatment. This study is testing whether a remote, group-based skills training program, delivered by videoconference, can help reduce symptoms of anxiety and depression in university students. The program, called RG-CBT (Remote Group Cognitive-Behavioral Therapy), was originally developed in South Africa for university students facing similar challenges: limited mental health resources and a lot of stigma around seeking help. It teaches practical cognitive-behavioral skills such as noticing and changing unhelpful thought patterns, becoming more active and engaged in daily life, and building problem-solving skills in a small-group format over video calls. Because it's delivered in groups rather than one-on-one, and doesn't require an in-person clinician for each student, it has the potential to reach many more students at a much lower cost than individual therapy.

How will the program's effectiveness be tested? The core of this study is a randomized controlled trial, which is the most rigorous way researchers can find out whether a treatment actually works.

Who takes part: 400 undergraduate students, 18 or older, from two public universities, who are experiencing meaningful symptoms of anxiety or depression (based on standard screening questionnaires).

How it works: Students who join the study are randomly assigned to one of two groups:

  • The treatment group receives the RG-CBT program: 10 weekly sessions, 90 minutes each, in small groups of 8-12 students, led by trained clinical psychology master's level students over video call. The sessions cover core skills like challenging unhelpful thoughts, becoming more behaviorally active, setting goals, solving problems, and relaxation techniques.
  • The comparison group uses a mood-tracking app instead, for the same 10-week period. This app lets students log their mood and reflect on their thoughts and activities, which has been shown in past research to offer some mild benefit, but without any structured skills training. This provides a meaningful yardstick to compare against, rather than comparing the program to nothing at all.

What will be measured: All students complete questionnaires online at three points in time: before starting (baseline), 3 months after they start the study, and again three months after that. The main things researchers want to know are whether anxiety and depression symptoms go down more in the group that received the skills training compared to the mood-tracking group. Researchers will also look at related outcomes, like feelings of belongingness to the university, social anxiety, feelings of social support, day-to-day functioning, and academic performance.

Researchers will also try to understand why the treatment works for those it helps, for example, by examining whether changes in thinking patterns, activity levels, or emotional regulation skills explain the improvement. And researchers will check whether the treatment works differently depending on students' background or the stress and hardship they've experienced, to better understand who benefits most.

How the results will be analyzed: Every student who enrolls and gets assigned to a group will be included in the final analysis, even if they don't finish all 10 sessions. This is a conservative approach that gives a realistic picture of how well the program would actually work if rolled out broadly, not just an idealized picture based only on students who stuck with it perfectly.

How will researchers know if the program can be used well in real life? Testing whether a treatment works in a controlled study is only part of the picture; researchers will also want to know whether it's something students actually want to use, whether it can be delivered as intended, and whether universities could realistically offer it. This is called an implementation evaluation, and it runs alongside the effectiveness trial.

To do this, the study will track:

  • How many students start and stick with the program, which reflects whether it's appealing and accessible enough for students to commit to it.
  • How satisfied students are with the treatment, gathered through standard satisfaction questionnaires after they finish.
  • Whether clinicians deliver the program as designed, by reviewing a sample of recorded sessions against a checklist of the key techniques the program is supposed to include. This is important because even a well-designed program only works if it's delivered the way it was intended.

Before the trial even begins, the research team also spent time adapting the program specifically for Mexican university students - translating materials, adjusting examples and language to fit the local culture, and gathering feedback from experts and students who have personally experienced anxiety or depression. This groundwork is meant to make sure that by the time the effectiveness trial starts, the program already feels relevant and relatable to the students taking part, which in turn supports better engagement and more meaningful results.

Why this study matters If the program proves effective and is well-received by students, the research team plans to freely share the clinician manual, student workbook, and training materials with universities so that other institutions facing the same shortage of mental health resources could offer this kind of support to their own students at low cost.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergraduate student enrolled in one of the participating universities
  • At least 18 years of age
  • Scoring 10 or more points on the PHQ-9 or the GAD-7
  • Provide informed consent

Exclusion criteria

  • Report that a professional gave them a diagnosis of bipolar disorder or psychosis

Treatment and study plan

Remote group cognitive behavioral skills training

Behavioral

10 weekly group sessions covering 5 core CBT themes delivered online through a videoconferencing platform following a facilitator manual and a fillable participant workbook.

Mood monitoring web application

Behavioral

Web app to monitor feelings, thoughts, behaviors and sleep patterns. Weekly and monthly feedback provided.

Primary outcomes

  1. Depressive symptoms

    Time frame: 3 and 6 months post randomization

    Change from baseline scores in the mean symptoms of depression as measured by the Patient Health Questionnaire-9 (PHQ-9) to mean symptoms of depression at follow-up. Scale scores range from 0 to 27 and higher scores mean worse depressive symptoms.

  2. Anxiety symptoms

    Time frame: 3 and 6 months post randomization

    Change from baseline scores in the mean symptoms of anxiety as measured by the Generalized Anxiety Disorder 7 scale (GAD-7) to mean symptoms of anxiety at follow-up. Scores range from 0 to 21 and higher scores represent worse anxiety symptoms.

Secondary outcomes

  1. Sense of school membership

    Time frame: 3 and 6 months post randomization

    Changes on mean scores on the Psychological Sense of School Membership (PSSM) Scale from baseline to follow-up. Scores range from 0 to 20 and higher scores represent great sense of school membership.

  2. Impairment

    Time frame: 3 and 6 months post-randomization

    Changes of mean score on the Army STARRS impairment measure of family, social, work and general functioning from baseline to follow-up. Scores range from 0 to 40, with higher scores representing greater impairment.

Study contacts

Contact information is provided by the study sponsor or research team.

Corina Benjet, PhD

CONTACT

[email protected]

+52 55 4160 5332

Kalina Martinez, PhD

CONTACT

[email protected]

+52 449 910 74 00

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Other

Collaborators

  • Universidad Autonoma de Baja California
  • Universidad Autónoma de Aguascalientes

Registry information

Official study title

Study of the Cultural Adaptation, Implementation, and Effectiveness of an Online Group Cognitive-behavioral Skills Training Program to Reduce Anxiety and Depression Among University Students

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 20, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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