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

NCT07246239 | Active Not Recruiting

• 2 other identifiers: CEIPSA-2024-PR-0023 Full RCT2023 Benes 00023
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Anxiety and Depression

Keywords

cognitive-behavioral treatment; internet-based program; depression; anxiety; students; university

Outcome Measures

Primary Outcomes (2)

• Anxiety

  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

  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 Outcomes (3)

• Functional impairment

  From enrollment to 6 months after being randomized

• Mental well-being

  From enrollment to 6 months after being randomized

• Resilience

  From enrollment to 6 months after being randomized

Study Arms (2)

Internet-based CBT program

EXPERIMENTAL

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)

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual involves referral to the counseling service offered by the university to its students.

Other: Counseling

Interventions

VIVIM (Viure la Vida al Màxim/Vivir la Vida al Máximo) BEHAVIORAL

This is the Internet-based CBT program

Internet-based CBT program

Counseling OTHER

This is the type of support that is offered from the university counseling services

Treatment as usual

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Rovira i Virgili: lead
• University Ramon Llull: collaborator
• Universitat de Girona: collaborator

Study Sites (3)

Blanquerna - Universitat Ramon Llull

Barcelona, Barcelona, 08022, Spain

Location

Universitat de Girona

Girona, Girona, Spain

Location

Universitat Rovira i Virgili

Tarragona, Tarragona, 43007, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Counseling

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal investigator

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 6 months after publication with no end date.

Locations

ES (3)