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| ID | Type | Description | Link |
|---|---|---|---|
| 2023 Benes 00023 | Other Grant/Funding Number | Agència de la Gestió d'Ajuts Universitaris i de Recerca (AGAUR) |
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| Name | Class |
|---|---|
| University Ramon Llull | OTHER |
| Universitat de Girona | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Treatment as usual | Active Comparator | Treatment as usual involves referral to the counseling service offered by the university to its students. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIVIM (Viure la Vida al Mà xim/Vivir la Vida al Máximo) | Behavioral | This is the Internet-based CBT program |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 6 months after being randomized |
| Mental well-being |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blanquerna - Universitat Ramon Llull | Barcelona | Barcelona | 08022 | Spain | ||
| Universitat de Girona |
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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Starting 6 months after publication with no end date.
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| Counseling | Other | This is the type of support that is offered from the university counseling services |
|
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 | 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 |
| Girona |
| Girona |
| Spain |
| Universitat Rovira i Virgili | Tarragona | Tarragona | 43007 | Spain |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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