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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07246239
Acronym
VIVIM
Enrollment
108
Registered
2025-11-24
Start date
2025-09-15
Completion date
2026-08-01
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety and Depression

Keywords

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

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.

Interventions

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

This is the Internet-based CBT program

OTHERCounseling

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

Sponsors

University Rovira i Virgili
Lead SponsorOTHER
University Ramon Llull
CollaboratorOTHER
Universitat de Girona
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
AnxietyFrom enrollment to 6 months after being randomizedThe Generalized Anxiety Disorder \[GAD-7\] will be used. The total score ranges from 0-21, with a higher score indicating higher symptoms severity
DepressionFrom enrollment to 6 months after being randomizedThe 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

MeasureTime frameDescription
Functional impairmentFrom enrollment to 6 months after being randomizedWork and Social Adjustment Scale \[WSAS\] will be used. The total score ranges from 0 to 40, with higher scores reflecting worse functioning.
Mental well-beingFrom enrollment to 6 months after being randomizedThe 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
ResilienceFrom enrollment to 6 months after being randomizedThe Connor-Davidson Resilience Scale \[CD-RISC-10\] will be used. The total score ranges from 0 to 40. Higher scores indicate greater resilience.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026