Evaluation of a Group Compassion-Based Program for Perceived Social Isolation and Depression in Family Caregivers of Patients With Multiple Sclerosis: Study Protocol for an Open-Label Randomized Controlled Trial Publisher Pubmed



Nabi F ; Yousefi H ; Babaee S ; Shaygannejad V
Source: Trials Published:2026

Abstract

Background: Multiple sclerosis (MS) is an autoimmune disorder of the central nervous system that causes neurologic disabilities. People with MS may need continuous care from a family caregiver. Caring is associated with physical and mental challenges, including mental health problems such as social isolation and depression. The health of patients is influenced by their caregivers’ health status. Therefore, this is a serious challenge faced by nurses in family-centered nursing care. Effective interventions, such as compassion-focused therapy (CFT), are needed to help caregivers continue caregiving and retain their health. The current study aims to evaluate the effects of a group CFT-based program on perceived social isolation and depression among family caregivers of people with MS. Methods: The current study will employ a two-arm, parallel-group randomized controlled trial design. Sixty family caregivers will be recruited via convenience sampling and then allocated into two equal groups. The participants in the intervention group will enroll in six weekly sessions of CFT-based psychoeducation, whereas the participants in the control group will receive no intervention. Data will be collected via a form for demographic information, the UCLA LS3, and the BDI-II at baseline, after intervention, and 2 months after the end of the program. Statistical analysis will be carried out using descriptive statistics, independent t-test, repeated measures ANOVA, and ANCOVA. Discussion: Previous studies have shown CFT effectiveness in several issues experienced by family caregivers, but its impact on social isolation and depression in family caregivers of people with MS is unknown. This study is the first to evaluate the effectiveness of CFT on social isolation and depression in family caregivers of people with MS, expanding our knowledge about CFT and caregiving challenges. Trial registration: Iranian Registry of Clinical Trials IRCT20230823059233N (https://irct.behdasht.gov.ir/trial/73412). Registered on 1 November 2021. Protocol version: Current protocol: Version 1 (28 October 2024). © The Author(s) 2026.