Virtue-Based vs. Cognitive-Behavioral Interventions in Patients With Chronic Medical Disease

NCT06501235 | Recruiting

• 1 other identifier: CEB-MAR-2023-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Well-Being, Psychological

Keywords

well-being; cognitive-behavioral intervention; virtue-based intervention

Outcome Measures

Primary Outcomes (4)

• Mental Health Continuum Scale (MHC-SF; Keyes, 2009)

  This 14-item scale measures emotional, social, and psychological well-being. It assesses the frequency of feeling a certain way during the last month. The Spanish version of Echevarría et al. (2017) will be used.

  Before (week 0) and after (week 9) intervention

• Cognitive Therapy Scale-Self Report (CCTS-SR) (Strunk et al., 2014)

  This 29-item scale measures the use of CBT skills during the last 2 weeks. The scale will be translated and adapted for use in this study.

  Before (week 0) and after (week 9) intervention

• Well-being Competencies Scale (WCS)

  This 16-item ad hoc scale was constructed to assess several well-being skills (e.g., mindfulness, savoring, gratitude) that are trained in the Well-being Training Based on Contemplative Practices (WTCP).

  Before (week 0) and after (week 9) intervention

• Generic Sense of Ability to Adapt Scale (GSAAS; Franken et al., 2023)

  This 10-item scale measures the ability to readjust after a personally challenging event (e.g., "I can handle setbacks well"). The scale will be translated and adapted for use in this study.

  Before (week 0) and after (week 9) intervention

Secondary Outcomes (8)

• Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006)

  Before (week 0) and after (week 9) intervention

• Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001)

  Before (week 0) and after (week 9) intervention

• Well-Being Locus of Control Scale (WB-LOC12; Farier et al., 2021)

  Before (week 0) and after (week 9) intervention

• Compassion Motivation and Action Scales (CMAS; Steindl et al., 2021)

  Before (week 0) and after (week 9) intervention

• Therapeutic Factors Inventory-Short Form (TFI-S; MacNair-Semands et al., 2010)

  After session 4 (week 4) and after (week 9) intervention

Other Outcomes (6)

• WHO-5 Questionnaire

  Before intervention (screening)

• MINI International Neuropsychiatric Interview (MINI) 5.0

  Before intervention (screening)

• Sociodemographic variables

  Before intervention (screening)

Study Arms (2)

Cognitive-Behavioral Therapy (CBT)

EXPERIMENTAL

This group will receive a 9-week CBT intervention.

Behavioral: Cognitive-Behavioral Therapy (CBT)

Virtue-Based Intervention (VBI)

EXPERIMENTAL

This group will receive a 9-week VBI intervention.

Behavioral: Virtue-Based Intervention (VBI)

Interventions

Cognitive-Behavioral Therapy (CBT) BEHAVIORAL

An adaptation of the Robles and Peralta's (2010) stress management program will be followed. This program includes key techniques from the CBT approach, such as deactivation techniques, cognitive restructuring, and assertiveness training.

Cognitive-Behavioral Therapy (CBT)

Virtue-Based Intervention (VBI) BEHAVIORAL

A Well-being Training based on Contemplative Practices (WTCP) (Cebolla \& Alvear, 2019; Alvear \& Cebolla, 2023) will be followed. WTCP combines mindfulness practices with various activities based on virtues such as gratitude, altruism, or compassion. This program focuses on generative or constructive meditations, and puts special emphasis on virtuous actions, emotion regulation (both positive and negative emotions) and compassion, and includes strategies from positive psychology, such as strengths-based interventions, savoring, kindness, or the three good things.

Virtue-Based Intervention (VBI)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of a mental disorder assessed with the Spanish edition of the Mini-International Neuropsychiatric Interview (MINI).
• Complications of the chronic medical disease that require hospital treatment.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Psychology and Speech Therapy, University of Valencia Valencia, Comunidad Valenciana, Spain, 46010

Valencia, Valencia, 46010, Spain

RECRUITING

Related Publications (1)

• Alvear, D., & Cebolla, A. (2023). La ciencia de la virtud. Manual de Entrenamiento en Bienestar basado en prácticas Contemplativas (EBC). Kairós. Cebolla, A., Herrero, R., Carrillo, A., Navarro, J., Soler, J., & Alvear, D. (2019). Contemplative practice-based well-being training (CBWT): Towards a contemplative positive psychology. In L. Galiana & N. Sansó (Eds.), The power of compassion (pp. 159-174). Nova Science Publishers. Keyes, C. L. M. (2009). Atlanta: Brief description of the mental health continuum short form (MHC-SF). Retrieved from https://peplab.web.unc.edu/wp-content/uploads/sites/18901/2018/11/MHC-SFoverview.pdf Robles, H., & Peralta, M. I. (2010). Programa para el control del estrés. Pirámide. Sarudiansky, M., Lanzillotti, A. I., Gerbaudo, M. A., Wolfzun, C., Kochen, S., Stivala, E., d'Alessio, L., & Korman, G. P. (2023). Cultural adaptation and psychometric properties of the Patient-weighted Quality of Life in Epilepsy 31 Inventory (QOLIE-31P) in Argentina. Epilepsy & Behavior, 141, 109132. https://doi.org/10.1016/j.yebeh.2023.109132

  BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ausiàs Cebolla Martí, PhD

  Univeristy of Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Navarro Siurana, PhD

CONTACT

+34963864407; jessica.navarro-siurana@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Model Details: Between subjects design

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 15, 2024
• Study Start: October 2, 2024
• Primary Completion: July 30, 2025
• Study Completion: December 1, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Following the publication of the article
• Access Criteria: Open access

Locations

ES (1)