Compassion-Based Intervention for Lung Cancer Caregivers (CBI-LCC)

Официальное название

Development and Evaluation of a Brief Compassion-Based Intervention for Managing Depression and Anxiety in Family Caregivers of Lung Cancer Patients: A Mixed Methods Randomized Controlled Trial

Обзор

Objectives: This 3-year study aims to develop, refine, and evaluate a brief compassion-based intervention specifically designed for family caregivers of lung cancer patients. In the first year, the primary focus will be on developing the intervention content and assessing its feasibility and acceptability. In the second and third years, the goal will be to assess the intervention's effects on depression and anxiety. Method: In the first year, the intervention will be developed in three stages. Initially, the intervention will be created based on compassion-focused theory and evidence-based exercises, incorporating feedback from family caregivers in previous studies and insights from professionals to ensure its relevance to lung cancer caregivers. Next, a pilot study will test the intervention's feasibility and acceptability with 30 family caregivers, using mixed methods to gather session-by-session feedback and assess recruitment, retention, and adherence. Following the pilot, the intervention will be revised based on participant and researcher feedback, preparing it for further study. In the second and third years, a randomized controlled trial (RCT) will be conducted with 84 participants randomly assigned to either the 4-session Brief Compassion-Based Intervention (BCI) or a single-session Telephone-Based Support and Education (TSE) control group. Outcomes, including depression, anxiety, caregiver stress, mindfulness, self-compassion, and self-efficacy, will be measured at baseline, immediately post-intervention, and at 3- and 6-month follow-ups. For data analysis, long-term follow-up quantitative data will be analyzed using the Generalized Estimating Equation (GEE) to examine group differences. Moderation and mediation analyses will be conducted to explore potential moderators and mechanisms of the intervention. Qualitative data from interviews will be analyzed using content analysis. Expected Results: This study is expected to provide a comprehensive understanding of the feasibility, acceptability, and effectiveness of compassion-based interventions for lung cancer caregivers, contributing to their application in clinical care practice.

Вмешательства

• Поведенческое Brief Compassion-Based Intervention (BCI)
  The intervention program is based on Compassion-Focused Therapy (CFT) and incorporates evidence-based compassion exercises.Drawing on insights from the literature, the program includes:Session 1: Introduction to caregiving challenges and emotional systems. Includes a soothing breathing exercise and group discussion on caregiving stress. Session 2: Cultivating self-compassion. Includes reflecting on emotions, guided meditation, and a compassionate body scan practice. Session 3: Transforming sel
• Поведенческое Telephone-Based Support and Education (TSE)
  The session will address their questions and concerns, provide psychological support for managing difficult emotions (e.g., anxiety, fear, sadness, and guilt), and emphasize the importance of self-care, encouraging them to take time for themselves and seek support when needed.

Первичные конечные точки

• Hospital Anxiety and Depression Scale (HADS) Questionnaire [Срок оценки: From baseline through study completion, up to 6 months.]

Вторичные конечные точки (4)

• Kingston Caregiver Stress Scale (KCSS) Questionnaire [Срок оценки: From baseline through study completion, up to 6 months.]
• Five Facet Mindfulness Questionnaire (FFMQ-15) [Срок оценки: From baseline through study completion, up to 6 months.]
• Self-Compassion Scale (SCS) Questionnaire [Срок оценки: From baseline through study completion, up to 6 months.]
• General Self-Efficacy Scale (GSES) Questionnaire [Срок оценки: From baseline through study completion, up to 6 months.]

Критерии участия

Критерии включения

• Primary family caregiver of a person with newly diagnosed lung cancer (within one year of diagnosis)
• Aged 20 years or older
• Access to a computer or smartphone with internet connection at home

Критерии исключения

• Currently receiving psychological therapy
• Diagnosed with a severe mental illness and taking medication for it (e.g.,psychosis, bipolar disorder)
• Previous experience with mindfulness or self-compassion training

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 1 центр

• Taipei Medical University — Taipei

Идентификаторы

NCT: NCT06930313 · N202411055 · IRB Approval Number

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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