Evaluating the Effectiveness of an Online Cognitive Behavioral Therapy Program for University Students With Depression and/or Anxiety (VIVIM)

April 28, 2026 updated by: Anna Huguet, University Rovira i Virgili

Evaluating the Effectiveness of an Online Cognitive Behavioral Therapy Program for University Students With Depression and/or Anxiety: A Randomized Controlled Trial

The goal of this clinical trial is to learn if an Internet-based self-help program called VIVIM can help university students with depression and/or anxiety. The main question investigadors want to answer is:

* Does the VIVIM program help participants to feel less depressed and/or anxious? The investigators will compare the VIVIM program with the usual psychological support that university counselling services offer to students.

Participants will:

  • Be randomly assigned to either use the VIVIM program or receive usual help from university's counselling service.
  • Fill out online questionnaires three times: at the beginning, 10 weeks and 6 months after being assigned either the VIVIM program or usual care.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08022
        • Blanquerna - Universitat Ramon Llull
    • Girona
      • Girona, Girona, Spain
        • Universitat de Girona
    • Tarragona
      • Tarragona, Tarragona, Spain, 43007
        • Universitat Rovira i Virgili

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • To be enrolled as an undergraduate or postgraduate at of the participating Spanish universities.
  • To report at least moderate symptoms of depression (PHQ>o= 10) and/or anxiety (GAD-7>o= 10).

Exclusion Criteria:

  • To self-report having been diagnosed with bipolar and/or psychotic disorder.
  • To report to be currently receiving psychotherapy/counselling and/or pharmacological treatment for emotional problems.
  • To be unable to read, speak or understand Spanish.
  • To be at risk of suicide.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet-based CBT program

This 10-week program consists of 10 modules. Throughout the program, participants progress at their own pace. They have the opportunity to attend two individual support sessions (at the beginning and midway through the program) as well as in weekly group support designed to address questions and reinforce learning. These sessions are conducted via videoconference. Participants also receive weekly automated email remainders and can contact the team via email at any time.

This program is an adaptation of Overcoming Low mood and Depresion: A Five Areas Approach.
Behavioral: VIVIM (Viure la Vida al Màxim/Vivir la Vida al Máximo)
This is the Internet-based CBT program
Active Comparator: Treatment as usual
Treatment as usual involves referral to the counseling service offered by the university to its students.
Other: Counseling
This is the type of support that is offered from the university counseling services

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: From enrollment to 6 months after being randomized
The Generalized Anxiety Disorder [GAD-7] will be used. The total score ranges from 0-21, with a higher score indicating higher symptoms severity
From enrollment to 6 months after being randomized
Depression
Time Frame: From enrollment to 6 months after being randomized
The Patient Health Questionnaire-9 item [PHQ-9] will be used. The total score ranges from 0 to 27, with a higher score indicating a higher symptom severity
From enrollment to 6 months after being randomized

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional impairment
Time Frame: From enrollment to 6 months after being randomized
Work and Social Adjustment Scale [WSAS] will be used. The total score ranges from 0 to 40, with higher scores reflecting worse functioning.
From enrollment to 6 months after being randomized
Mental well-being
Time Frame: From enrollment to 6 months after being randomized
The Five Well-Being Index (WHO-5) will be used. The total score is the sum of all items, with high scores indicating a better well-being. and the row scores are transformed to a 0 (worst imaginable well-being) -100 (best imaginable well-being) scale
From enrollment to 6 months after being randomized
Resilience
Time Frame: From enrollment to 6 months after being randomized
The Connor-Davidson Resilience Scale [CD-RISC-10] will be used. The total score ranges from 0 to 40. Higher scores indicate greater resilience.
From enrollment to 6 months after being randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Rovira i Virgili

Collaborators

Universitat de Girona
University Ramon Llull

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIPSA-2024-PR-0023 Full RCT
  • 2023 Benes 00023 (Other Grant/Funding Number: Agència de la Gestió d'Ajuts Universitaris i de Recerca (AGAUR))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie results in a publication will be shared in the data repository of the Univesitat Rovira i Virgili.

IPD Sharing Time Frame

Starting 6 months after publication with no end date.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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