跳至主要内容
临床试验/NCT04656808
NCT04656808终止不适用

Guilt Feelings, Dysfunctional Thoughts, Cultural Values and Mental and Physical Health of Dementia Family Caregivers: Longitudinal, Intervention and Experimental Analysis

Universidad Rey Juan Carlos1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
110
试验地点
1
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

  1. 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).
  2. 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.
  3. 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.
  4. The interviews will consist in questions and questionnaires specifically selected for the project.
  5. 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).
  6. 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.
  7. 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

研究组 & 干预措施

Guilt focused intervention

Experimental

Following literature on factors associated with guilt experiences in caregivers (Gonyea et al., 2008; Gallego-Alberto et al., 2019; Losada et al., 2014; Prunty & Foli, 2019; Romero-Moreno et al., 2014; Spillers et al., 2008) and previous intervention studies testing an Acceptance and Commitment Therapy intervention for dementia family caregivers (Losada et al., 2015; Márquez-González et al., 2020), a guilt focused intervention was specifically designed for caregivers who experienced high levels of guilt and emotional distress. The program is based on CBT (Márquez-González et al., 2007) and Acceptance and Commitment Therapy (ACT) approaches (Losada et al., 2005; Márquez-González et al., 2010), combined with techniques of Compassion-Focused Therapy (CFT; Gilbert, 2009), which were adapted to work with guilt experienced by family dementia caregivers.

干预措施: Guilt Focused Intervention (Behavioral)

Cognitive behavioral therapy

Active Comparator

Following the cognitive behavioral model adapted to caregiving (Losada et al., 2006) and considering other previous CBT intervention studies with dementia caregivers (Gallagher-Thompson et al., 2003), a CBT intervention developed and tested for dementia family caregivers (Márquez-González et al., 2007) was used for this study. Specifically, this intervention consists of different components that are described in more detail in Losada et al. (2011) and Márquez-González et al. (2007): a) a cognitive restructuring module aimed at modifying caregivers' dysfunctional thoughts about caregiving into other, more appropriate thoughts which promote the use of more adaptive coping strategies for caregivers; b) increasing pleasant activities or behavioral activation; c) asking for help skills; and d) relaxation techniques for reducing physiological activation.

干预措施: Cognitive behavioral therapy (Behavioral)

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrés Losada Baltar

Full Professor

Universidad Rey Juan Carlos

研究点 (1)

Loading locations...

相似试验