Comparing two approaches to improve well-being in patients with chronic diseases
Barriers vs. Resources: A Mechanistic Randomized Clinical Trial Comparing Virtue-Based and Cognitive-Behavioral Interventions in Patients With Chronic Medical Disease
This study is testing whether Cognitive Behavioral Therapy or a Virtue-Based Intervention can help improve well-being in people with chronic diseases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Valencia Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT06501235 on ClinicalTrials.gov |
What this trial studies
This study aims to analyze the mechanisms of change in two interventions designed to enhance well-being in patients with chronic medical diseases: Cognitive Behavioral Therapy (CBT) and Virtue-Based Intervention (VBI). It will involve a randomized controlled trial with participants assigned to either CBT or VBI, followed by assessments at multiple points including pre- and post-intervention, as well as 6 and 12 months later. The focus will be on evaluating well-being, anxiety, depression, and specific mechanisms related to each intervention. Participants will engage in daily assessments during the treatment period to monitor their well-being.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a chronic medical disease and low well-being scores.
Not a fit: Patients with a diagnosed mental disorder or complications requiring hospital treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective strategies to enhance well-being in patients suffering from chronic medical conditions.
How similar studies have performed: While there are effective interventions for well-being, this study's focus on comparing CBT and VBI mechanisms is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged between 18 and 70 years old. 2. Able to read and write in Spanish. 3. Having a computer with internet access in a safe place (home or private office) and the skills to use it. 4. 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). 5. Having a diagnosis of a chronic medical disease (diabetes, epilepsy, cancer, etc.) according to standard criteria. Exclusion Criteria: 1. Diagnosis of a mental disorder assessed with the Spanish edition of the Mini-International Neuropsychiatric Interview (MINI). 2. Complications of the chronic medical disease that require hospital treatment.
Where this trial is running
Valencia, Valencia
- Faculty of Psychology and Speech Therapy, University of Valencia Valencia, Comunidad Valenciana, Spain, 46010 — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Ausiàs Cebolla Martí, PhD — Univeristy of Valencia
- Study coordinator: Jessica Navarro Siurana, PhD
- Email: jessica.navarro-siurana@uv.es
- Phone: +34963864407
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.