Anxiety and DepressionVIVIMNCT07246239
Evaluating the Effectiveness of an Online Cognitive Behavioral Therapy Program for University Students With Depression and/or Anxiety
A study testing VIVIM (Viure la Vida al Màxim/Vivir la Vida al Máximo) and Counseling in people with Anxiety and Depression, run by University Rovira i Virgili at 3 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anxiety and Depression
- What is being tested?
- VIVIM (Viure la Vida al Màxim/Vivir la Vida al Máximo) and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 3 sitesSpain
- Study dates
- 15 Sep 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Blanquerna - Universitat Ramon Llull
Barcelona, Barcelona, 08022
Universitat de Girona
Girona, Girona
Universitat Rovira i Virgili
Tarragona, Tarragona, 43007
About this study
Official title: 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.
Read more
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
- Being tested
- VIVIM (Viure la Vida al Màxim/Vivir la Vida al Máximo), Counseling
- Keywords
- cognitive-behavioral treatment, internet-based program, depression, anxiety, students, university
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVIM (Viure la Vida al Màxim/Vivir la Vida al Máximo)Behavioural
This is the Internet-based CBT program
CounselingOther
This is the type of support that is offered from the university counseling services
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From enrollment to 6 months after being randomized
Secondary outcomes (3)
Functional impairment
Work and Social Adjustment Scale [WSAS] will be used. The total score ranges from 0 to 40, with higher scores reflecting worse functioning.
Measured: From enrollment to 6 months after being randomized
Mental well-being
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
Measured: From enrollment to 6 months after being randomized
Resilience
The Connor-Davidson Resilience Scale [CD-RISC-10] will be used. The total score ranges from 0 to 40. Higher scores indicate greater resilience.
Measured: From enrollment to 6 months after being randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start15 Sep 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- University Ramon Llull, Universitat de Girona
- Responsible party
- Principal investigator, Anna Huguet, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246239
- Sponsor's protocol ID
- CEIPSA-2024-PR-0023 Full RCT
- Other IDs
- 2023 Benes 00023
- Acronym
- VIVIM
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in a publication will be shared in the data repository of the Univesitat Rovira i Virgili.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of an Online Cognitive Behavioral Therapy Program for University Students With Depression and/or Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07246239
- Acronym / sponsor ID
- VIVIM / CEIPSA-2024-PR-0023 Full RCT
- Conditions
- Anxiety and Depression
- Keywords
- cognitive-behavioral treatment, internet-based program, depression, anxiety, students, university
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- University Ramon Llull, Universitat de Girona
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based CBT program | Experimental | Behavioral: VIVIM (Viure la Vida al Màxim/Vivir la Vida al Máximo)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. |
| Treatment as usual | Active comparator | Other: CounselingTreatment as usual involves referral to the counseling service offered by the university to its students. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIVIM (Viure la Vida al Màxim/Vivir la Vida al Máximo)This is the Internet-based CBT program | Behavioural | Internet-based CBT program |
| CounselingThis is the type of support that is offered from the university counseling services | Other | Treatment as usual |
Primary outcome
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
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
3 secondary outcomes
Functional impairment
Time frame: From enrollment to 6 months after being randomized
Mental well-being
Time frame: From enrollment to 6 months after being randomized
Resilience
Time frame: From enrollment to 6 months after being randomized
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in a publication will be shared in the data repository of the Univesitat Rovira i Virgili.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIVIM (Viure la Vida al Màxim/Vivir la Vida al Máximo) and Counseling in people with Anxiety and Depression, run by University Rovira i Virgili at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: From enrollment to 6 months after being randomized). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.