ClinicalTrials.gg
Not yet recruitingNCT07776236Updated Aug 21, 2026

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

An interventional study of Remote group cognitive behavioral skills training and Mood monitoring web application in Depression and Anxiety Symptoms, sponsored by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Depression and Anxiety Symptoms

Keywords

  • depression
  • anxiety
  • cognitive behavioral
  • Mexico
  • university students
  • remote group therapy
03

In context

Depression

8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.

This study's planned enrollment of 400 is above the median of 81 across 7,063 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente is the lead sponsor of 14 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Report that a professional gave them a diagnosis of bipolar disorder or psychosis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Remote group cognitive behavioral skills training

    Behavioral: Remote group cognitive behavioral skills training

  • Active comparator
    Mood monitoring web application

    Web application to monitor daily emotions, thoughts, behaviors and sleep patterns

    Behavioral: Mood monitoring web application

Interventions

  • BehavioralRemote group cognitive behavioral skills training

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

  • BehavioralMood monitoring web application

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 3 and 6 months post randomization

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 3 and 6 months post-randomization

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — De-identified data and supporting information will be shared upon reasonable written request.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: 3 months after termination of the study.

Access criteria: Official request to the PI at cbenjet@inprf.gob.mx

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Aug 2028, 24 months later.

Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 24 months is above that.

Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 20, 2026
StartEst.
Aug 18, 2026
Primary completionEst.
Aug 2028
CompletionEst.
Mar 2029
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07776236
Lead sponsor
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Collaborators
Universidad Autónoma de Aguascalientes, Universidad Autonoma de Baja California
Responsible party
Corina Benjet (Senior Researcher in Medical Science, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente) — Principal investigator
First posted
Aug 20, 2026
Start date
Aug 18, 2026 (estimated)
Primary completion
Aug 2028 (estimated)
Completion
Mar 2029 (estimated)
Last update
Aug 21, 2026

Study contacts

Corina Benjet, PhD
Contact
cbenjet@inprf.gob.mx
+52 55 4160 5332
Kalina Martinez, PhD
Contact
kalina.martinez@edu.uaa.mx
+52 449 910 74 00
Corina Benjet, PhD
principal investigator · Instituto Nacional de Psiquiatría Ramon de la Fuente Muñiz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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