Effectiveness of the Internet Attachment-Based Compassion Therapy (iABCT) to Improve the Quality of Life and Well-being in a Population with Chronic Medical Illness: A Study Protocol of a Randomized Controlled Trial (SPIRIT Compliant)
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Background: Chronic medical illnesses significantly and negatively affect the quality of life of individuals who suffer them and represent one of the most important challenges faced by healthcare providers and policy-makers due to its rising prevalence and high rates of comorbidity. Compassion-based interventions delivered over the Internet may be a useful approach to facilitate illness management and improve the quality of life of individuals with chronic medical conditions.
Objectives: The purpose of this study is to describe a protocol for a randomized controlled trial to test the efficacy of the Internet Attachment-Based Compassion Therapy (iABCT) to improve the quality of life and well-being of patients with chronic medical illnesses.
Method: A two-arm, parallel-group, randomized controlled trial (RCT) will be carried out, with three assessment points (baseline, 3-month, and 6-month) under two conditions: intervention group and control group (waiting list). The primary outcomes include the quality of life on the EuroQol 5-Dimensions Questionnaire (EQ-5D) and the Pemberton Happiness Index (PHI). Secondary outcomes, such as compassion, self-care behaviors, illness interference, self-criticism, symptomatology, attachment styles, social support, and illness perception, will be considered. Moreover, an assessment on satisfaction and usability will be carried out. A total of 68 participants as minimum will be recruited (34 per arm). Intent-to-treat mixed-model analyses without any ad hoc imputations will be conducted.
Conclusions: Findings of this study will provide new insights into the potential of self-applied compassion-based interventions (CBI) delivered online in the context of chronic medical illnesses, considering aspects of their implementation (e.g., facilitators, barriers) and mechanisms of change.
Trial Registration: The study is registered under Clinicaltrials.gov (NCT04809610) and it is currently in the participant recruitment phase.
Bitencourt S, Huang B, de Oliveira I, Demarzo M MethodsX. 2024; 13:103021.
PMID: 39553736 PMC: 11566881. DOI: 10.1016/j.mex.2024.103021.