跳至主要内容
临床试验/NCT03391596
NCT03391596已完成不适用

CareACT - Internet-based Intervention for Enhancing the Psychological Well-being of Elderly Caregivers

The Gerocenter Foundation for Research and Development2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
151
试验地点
2
主要终点
The Beck Depression Inventory (BDI-II): change from baseline to 4 months and 10 months

研究概览

简要总结

This study will examine whether an Internet-based Acceptance and Commitment Therapy (ACT) intervention is effective, firstly, on reducing depressive symptoms, and, secondly, on improving well-being of elderly family caregivers. In our study, we will compare 1) the experimental Internet-based ACT group to 2) standardized institutional rehabilitation carried out in rehabilitation centers and to 3) support provided by voluntary family caregiver associations

详细描述

It is well-known that stress, low quality of life and depression are relatively common problems among family caregivers. The proportion of elderly family caregivers is rapidly increasing which emphasizes the need for new support systems. Internet-delivered psychological interventions are one possible approach, offering benefits as they are more easily to achieve for family caregivers who often are home-bound with their relatives.

This study will examine whether an Internet-based Acceptance and Commitment Therapy intervention would be effective, firstly, on reducing depressive symptoms, and, secondly, on improving well-being of elderly family caregivers.The family caregivers' depressive symptoms, perceived burden, anxiety, quality of life, psychological flexibility, personality and physical performance will be studied by a quasi-experimental study design comparing three groups of family caregivers (Group 1, experimental: Internet-based ACT intervention; Group 2, active comparator: Standardized institutional rehabilitation in a rehabilitation center; Group 3, other: Support given by voluntary family caregiver associations). Data collection will be performed at three time points: pre, 4 months and post (10 months).

Secondly, we also aim to examine demographics and psychological variables that could predict change in depression and perceived burden over time (pre, 4 months and post (10 months). A further aim of the study is to examine potential mediators on the effect of the interventions including psychological flexibility and suppression of thoughts. Moreover, we aim to study user experiences and satisfaction of the Internet-based program, i.e., how the family caregivers experience and accept the web-based ACT intervention.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for all groups:
  • family caregiver
  • at least 60 years of age
  • Inclusion Criteria for the experimental and active comparator group - depressive symptoms and/or psychological distress

排除标准

  • for all groups:
  • parallel psychological treatment
  • severe mental disorder
  • Additional inclusion criteria for the experimental group:
  • - computer and Internet connection or willingness to use a tablet provided by the study

结局指标

主要结局

The Beck Depression Inventory (BDI-II): change from baseline to 4 months and 10 months

时间窗: baseline, 4 months, post (10 months)

The BDI-II contains 21 questions about depressive symptoms and their severity. The scale ranges from 0 to 63 and the items are summed (0 to 13 indicates no or very few depressive symptoms, 14 to 19 indicates mild depression, 20 to 28 moderate depression, and 29 to 63 severe depression).

次要结局

  • Sense of Coherence (SOC-13): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • Acceptance and Action Questionnaire (AAQ-II): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • White Bear Suppression Inventory (WBSI): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • Carers of Older People in Europe (COPE): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • WHO Quality of Life-BREF (WHOQOL-BREF): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • Generalized Anxiety Disorder 7-item (GAD-7) scale: change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • Short Physical Performance Battery (SPPB): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • The 'Short Five' (S5): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • Experiential Avoidance in Caregiving Questionnaire (EACQ): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))

研究者

发起方
The Gerocenter Foundation for Research and Development
申办方类型
Other
责任方
Principal Investigator
主要研究者

Riku Nikander

PhD, professor

The Gerocenter Foundation for Research and Development

研究点 (2)

Loading locations...

相似试验