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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Taipei Medical University
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Hospital Anxiety and Depression Scale (HADS) Questionnaire
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Masking Description
Participant Masking Description: Participants will not be informed of their group allocation (Intervention or Control group). While participants will know the specific type of support they are receiving (e.g., Compassion-Based Intervention or Telephone-Based Support), they will not be aware of which group is considered the experimental intervention.
Investigator Masking: Investigators responsible for data collection and analysis will be blinded to group allocation to maintain objectivity.
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Hospital Anxiety and Depression Scale (HADS) Questionnaire
Time Frame: From baseline through study completion, up to 6 months.
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS), a validated self-report questionnaire developed by Zigmond and Snaith in 1983. The HADS comprises 14 items divided into two subscales: anxiety (7 items) and depression (7 items). Participants will rate the frequency of symptoms experienced during the past week on a 4-point Likert scale ranging from 0 ("not at all") to 3 ("most of the time"). Scores on each subscale range from 0 to 21, with higher scores indicating greater levels of anxiety or depression.
Secondary Outcomes
- Kingston Caregiver Stress Scale (KCSS) Questionnaire(From baseline through study completion, up to 6 months.)
- Five Facet Mindfulness Questionnaire (FFMQ-15)(From baseline through study completion, up to 6 months.)
- Self-Compassion Scale (SCS) Questionnaire(From baseline through study completion, up to 6 months.)
- General Self-Efficacy Scale (GSES) Questionnaire(From baseline through study completion, up to 6 months.)