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NCT Number: NCT07246239

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Anxiety and Depression Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blanquerna - Universitat Ramon Llull, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Behavioral

This is the Internet-based CBT program

Counseling

Other

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

University Rovira i Virgili

Other

Collaborators

  • Universitat de Girona
  • University Ramon Llull

Registry information

Official study title

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

Acronym: VIVIM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
May 5, 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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