Guilt Feelings, Dysfunctional Thoughts, Cultural Values and Mental and Physical Health of Dementia Family Caregivers: Longitudinal, Intervention and Experimental Analysis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Guilt symptoms
研究概览
简要总结
Participants in the intervention study will be 120 caregivers with guilt feelings linked with care and high levels of emotional distress (anxiety and/or depression), randomly allocated to the intervention conditions: intervention group and cognitive-behavioral comparison group. The intervention will be provided in a group setting and will consist in 8 sessions plus 3 booster sessions. The effect of the intervention on guilt feelings, depressive and anxious symptomatology, and biomarkers of cardiovascular risk will be assessed after the intervention and at follow-ups at 6 months.
详细描述
- Contact with collaborator centers. Centers with previous collaboration with the research team will provide contact data of potential participants. In addition, information of the project will be made available through posters, news, and internet (e.g., social networks).
- Previous to the assessment each participant will be randomly allocated to the intervention conditions (guilt focused intervention (GFI) and cognitive behavioral therapy (CBT)) following the CONSORT recommendations. Randomization will be made through random numbers using computerized procedures.
- Once contacted, caregivers will be requested to sign an informed consent and, if the inclusion criteria are met, the interview will take place. Interviews will be conducted by trained psychologists blinded to the project aims and hypothesis.
- The interviews will consist in questions and questionnaires specifically selected for the project.
- The intervention conditions have been developed following previous studies by the team or recognized researchers, or following previous research studies in the topic of caregiving stress or related topics (e.g. psychotherapeutic strategies for reducing distress).
- The interventions will take place in group format (maximum 8 participants per group). Each intervention will consist in 8 weekly sessions plus 3 booster sessions in a 5 month period.
- Participants will be assessed again after the intervention (2 months) and at the follow-up (6 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and assessors are blinded to the study research objectives and aims and to the available and obtained treatment condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Identifying themselves as the main caregiver of the relative with dementia
- •Dedicating at least one daily hour to caregiving tasks
- •Having cared for at least three consecutive months
- •Not having participated in a psychotherapeutic intervention in the last year
- •Showing scores equal or higher than 16 on the Center for Epidemiological Studies-Depression Scale (CES-D; Radloff, 1977) and/or 13 on the Tension-Anxiety subscale from the Profile of Mood States scale (POMS; McNair et al., 1971)
- •Showing a score of at least 16 in the Caregiver Guilt Questionnaire (Losada et al., 2010).
排除标准
- •Those different to the inclusion criteria
结局指标
主要结局
Guilt symptoms
时间窗: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
Caregivers' feelings of guilt are measured using the Caregiver Guilt Questionnaire (Losada, A., Márquez-González, M., Peñacoba, C., \& Romero-Moreno, R., 2010)
Anxiety symptoms
时间窗: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
Caregivers' symptoms of anxiety are measured through the Tension-Anxiety subscale from the Profile of Mood States (POMS; McNair, Lorr, \& Droppleman, 1971)
Depressive symptoms
时间窗: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
The Center for Epidemiological Studies-Depression Scale (CES-D; Radloff, 1977) is used
次要结局
- Caregiving stressors(Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention))
研究者
Andrés Losada Baltar
Full Professor
Universidad Rey Juan Carlos