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Depression and Anxiety SymptomsNCT07776236

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

A study testing Remote group cognitive behavioral skills training and Mood monitoring web application in people with Depression and Anxiety Symptoms, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression and Anxiety Symptoms
What is being tested?
Remote group cognitive behavioral skills training and Mood monitoring web application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
No sites listed yet
Study dates
18 Aug 2026to Mar 2029
Phase
Interventional

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Corina Benjet, PhD contact

+52 55 4160 5332

cbenjet@inprf.gob.mx

About this study

Official 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

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.

Read the detailed description

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.

Being tested
Remote group cognitive behavioral skills training, Mood monitoring web application
Keywords
depression, anxiety, cognitive behavioral, Mexico, university students, remote group therapy
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.

  • Remote group cognitive behavioral skills trainingBehavioural

    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 applicationBehavioural

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

Study groups in NCT07776236
Study groupRoleWhat they receive
Remote group cognitive behavioral skills trainingExperimentalNot described
Receives: Behavioral: Remote group cognitive behavioral skills training
Mood monitoring web applicationActive comparatorWeb application to monitor daily emotions, thoughts, behaviors and sleep patterns
Receives: Behavioral: Mood monitoring web application

What is being measured

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

  1. Depressive symptoms

    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.

    Measured: 3 and 6 months post randomization

  2. Anxiety symptoms

    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.

    Measured: 3 and 6 months post randomization

Secondary outcomes (2)
  1. Sense of school membership

    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.

    Measured: 3 and 6 months post randomization

  2. Impairment

    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.

    Measured: 3 and 6 months post-randomization

Timeline

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

  1. First posted20 Aug 2026
  2. Study start18 Aug 2026 (estimated)
  3. Primary completionAug 2028 (estimated)
  4. Study completionMar 2029 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07776236
Sponsor's protocol ID
EP26240
Other IDs
CBF-2025-G-1652
Status last verified
Aug 2026
First submitted
17 Aug 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data and supporting information will be shared upon reasonable written request.

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