Virtue-Based vs. Cognitive-Behavioral Interventions in Patients With Chronic Medical Disease
NCT Number: NCT06501235
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Well-Being, Psychological
Interventions: BEHAVIORAL: Cognitive-Behavioral Therapy (CBT)|BEHAVIORAL: Virtue-Based Intervention (VBI)
Sponsor: University of Valencia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-12
Locations: Faculty of Psychology and Speech Therapy, University of Valencia Valencia, Comunidad Valenciana, Spain, 46010, Valencia, 46010, Spain

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).

Primary Outcome Measures: 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 Outcome Measures: Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006), This 7-item instrument measures the presence of anxious symptoms in the last 15 days. Higher scores indicate a greater presence of anxious symptomatology. The Spanish version of García-Campayo et al. (2010) will be used., Before (week 0) and after (week 9) intervention|Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001), This 9-item instrument measures the presence of depressive symptoms in the last 2 weeks. The severity of symptomatology is classified into 4 levels: 0-4 (minimal), 5-9 (mild), 10-14 (moderate), 15-19 (moderate-severe), and 20-27 (severe). The Spanish version of Diez-Quevedo et al. (2001) will be used., Before (week 0) and after (week 9) intervention|Well-Being Locus of Control Scale (WB-LOC12; Farier et al., 2021), This 12-item scale measures the degree of expectancy about well-being control. It is composed of three factors: internal, others, and opportunities. The scale will be translated and adapted for use in this study., Before (week 0) and after (week 9) intervention|Compassion Motivation and Action Scales (CMAS; Steindl et al., 2021), This instrument encompasses two dimensions assessing self-compassion and compassion to others' motivation and action. The self-compassion dimension encompasses 18 items, and the compassion to others dimension includes 12 items. The scale will be translated and adapted for use in this study., Before (week 0) and after (week 9) intervention|Therapeutic Factors Inventory-Short Form (TFI-S; MacNair-Semands et al., 2010), Compassion Motivation and Action Scales (CMAS; Steindl et al., 2021), After session 4 (week 4) and after (week 9) intervention|MPOQ-Common Factor Scale (Finsrud et al., 2021), This 14-item scale assesses common relational factors in psychological treatments. It includes two factors: trust in the therapist and trust in the treatment. The scale will be translated and adapted for use in this study., After session 4 (week 4) and after (week 9) intervention|Diabetes Distress Scale (DDS; Polonsky et al., 2005), This 17-item instrument measures stress symptoms related to suffering from diabetes in the last month. It includes 4 factors: emotional stress, physician stress, regimen stress, and interpersonal stress. The Spanish version of Ortiz et al. (2013) will be used., Before (week 0) and after (week 9) intervention|Quality of life in epilepsy-31 inventory (QOLIE-31-P; Cramer et al., 1998), This 39-item instrument assesses quality of life of patients with epilepsy, including 7 factors: energy/fatigue, mood, daily activities, cognition, medication effects, seizure worry, and overall quality of life. The Spanish version of Sarudiansky et al. (2023) will be used., Before (week 0) and after (week 9) intervention
Other Outcome Measures: WHO-5 Questionnaire, The World Health Organization's 5-item Well-Being Index (WHO-5) is a brief, generic global rating scale that measures subjective well-being. It assesses how often participants felt a certain way during the past two weeks., Before intervention (screening)|MINI International Neuropsychiatric Interview (MINI) 5.0, This is a structured diagnostic psychiatric interview used by mental health professionals to assess a range of psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders and the International Classification of Diseases. It's a standardized tool used in clinical and research settings to help diagnose conditions such as depression, anxiety disorders, and bipolar disorder., Before intervention (screening)|Sociodemographic variables, Information on sex, gender, marital status, educational level, and employment status, will be collected., Before intervention (screening)|Adherence, It will be evaluated through the presence of the sessions and completion of homework assignments., After (week 9) intervention|Satisfaction and opinion with intervention, Ad hoc questions will be asked about satisfaction and opinion about the treatment., After (week 9) intervention|Ecological Momentary Assessment, The level of well-being and the competencies from the Wellbeing Training based on Contemplative Practices (WTCP) were assessed daily using the m-Path app (https://m-path.io/landing/) with nine ad hoc items., Daily, from one week before the start of the intervention until one week after the end of the intervention (i.e., during 70 days).