Virtue-Based vs. Cognitive-Behavioral Interventions in Patients With Chronic Medical Disease (NCT06501235) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Virtue-Based vs. Cognitive-Behavioral Interventions in Patients With Chronic Medical Disease
Spain100 participantsStarted 2024-10-02
Plain-language summary
The aim of this study is to analyze the specific and common mechanisms of change of two active treatments, one based on reducing barriers -Cognitive Behavioral Therapy (CBT)- and the other based on enhance resources -Virtue-Based Intervention (VBI)- for increasing well-being in patients with chronic medical disease. A mechanistic randomized controlled trial will be conducted with two experimental conditions (CBT and VBI) and four evaluation points (pre- and post-intervention and 6- and 12-month follow-up).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged between 18 and 70 years old.
. Able to read and write in Spanish.
. Having a computer with internet access in a safe place (home or private office) and the skills to use it.
. Having a low level of well-being (i.e., a score of less than 13 on the WHO well-being index, assessed with the WHO-5 questionnaire).
. Having a diagnosis of a chronic medical disease (diabetes, epilepsy, cancer, etc.) according to standard criteria.
Exclusion criteria
. Diagnosis of a mental disorder assessed with the Spanish edition of the Mini-International Neuropsychiatric Interview (MINI).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mental Health Continuum Scale (MHC-SF; Keyes, 2009)
Timeframe: Before (week 0) and after (week 9) intervention
2
Cognitive Therapy Scale-Self Report (CCTS-SR) (Strunk et al., 2014)
Timeframe: Before (week 0) and after (week 9) intervention
3
Well-being Competencies Scale (WCS)
Timeframe: Before (week 0) and after (week 9) intervention
4
Generic Sense of Ability to Adapt Scale (GSAAS; Franken et al., 2023)
Timeframe: Before (week 0) and after (week 9) intervention