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In It Together: Using Acceptance and Commitment Therapy to Treat Distress Among Older Adults With Sensory Loss and Their Spouses (SoS)

2022年11月3日 更新者:Camilla Stine Øverup、University of Copenhagen
Impairments in hearing and/or vision are common in older age. Having lived one's life as a fully sighted and hearing individual, older adults with sensory loss must come to terms with their declining capacity to interact with others and waning independence. There is ample research evidence showing that sensory loss (i.e., loss of hearing, vision or both) can be a distressful experience for older adults and their spouses, yet little has been done to understand what works in alleviating this distress or develop scalable cost-effective interventions to counter this distress or associated outcomes like depression, anxiety, poor quality of life, and lower relationship quality. In this project, the investigators will design and test an easy-to-administer, online intervention aimed at reducing emotional and marital distress in older adults with sensory loss and their spouses. The goal of the intervention will be to develop acceptance of the sensory loss through a series of Acceptance and Commitment Therapy inspired educational, self-compassion, and therapeutic activities. In prior research, acceptance has been flagged as a promising factor on which to intervene to assist older couples' emotional and marital recovery in the context of sensory loss. Thus, the investigators expect that the intervention should show encouraging results regarding the alleviation of distress in this group and contribute significantly to the psychosocial rehabilitation of older adults with sensory loss and their spouses.

研究概览

研究类型

介入性

注册 (实际的)

662

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Copenhagen、丹麦、1014
        • University of Copenhagen

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Be 60 years of age or older
  • Be able to read and write in Danish
  • Be in a romantic relationship of at least 1 year
  • Live together with the partner (share housing)
  • Feel either one self or one's partner has a sensory loss (hearing and/or sight) that affects day-to-day life. This sensory loss does not need to be confirmed by a health care provider.

Exclusion Criteria:

  • Less than 60 years of age
  • Cannot read or write in Danish
  • Not in a romantic relationship
  • Relationship length of less than 1 year
  • Not living together with the partner (not share housing)
  • Currently receiving psychological help (therapy/intervention)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention group
Gains access to the digital intervention program
Digital intervention program that consists of 4 modules, to be completed 1 week apart. The modules consist of psychoeducation, as well as acceptance and commitment therapy-inspired activities.
其他名称:
  • Danish: Sammen on Sansetab (SOS)
无干预:Wait-list- control group
Does not gain access to the intervention (until end of study)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
WHO-5 well-being
大体时间:Within the last 2 weeks
5-item measure of general well-being (Bech, 1999, 2012)
Within the last 2 weeks
Couple Satisfaction Index
大体时间:Follow-up 1: During the last 6 weeks
4-item measure of satisfaction with one's romantic relationship (Funk & Rogge, 2007)
Follow-up 1: During the last 6 weeks
Depression
大体时间:Within the last 2 weeks

9-item measure of depressive symptoms (PHQ-9; Kroenke, Spitzer, & Williams, 2001; Kroenke

& Spitzer, 2002)

Within the last 2 weeks

次要结果测量

结果测量
措施说明
大体时间
Psychological flexibility
大体时间:Follow-up 1: During the last 6 weeks
7-item measure of psychological flexibility (AAC-II; Bond, Hayes, Baer, Carpenter, Guenole, Orcutt, Waltz, & Zettle, 2011).
Follow-up 1: During the last 6 weeks
Communication
大体时间:Follow-up 1: During the last 6 weeks
12-item measure of satisfaction with communication with partner (Jones, Jones, & Morris, .018)
Follow-up 1: During the last 6 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Camilla S Øverup, PhD、University of Copenhagen
  • 首席研究员:Gert Martin Hald, PhD、University of Copenhagen

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年11月22日

初级完成 (实际的)

2022年5月16日

研究完成 (实际的)

2022年6月30日

研究注册日期

首次提交

2021年1月18日

首先提交符合 QC 标准的

2021年3月1日

首次发布 (实际的)

2021年3月4日

研究记录更新

最后更新发布 (实际的)

2022年11月4日

上次提交的符合 QC 标准的更新

2022年11月3日

最后验证

2022年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • VELUX 22361
  • 1779339 (其他标识符:Danish Data Protections Agency)
  • 504-0225/20-5000 (其他标识符:University of Copenhagen Research Ethics Committee for Science and Health)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

We will share all individual data, along with a data dictionary and analytic code. The data will be anonymized prior to sharing. The materials will be uploaded to a data repository (which as yet to be determined)

IPD 共享时间框架

The data will be shared after June 30th, 2022.

IPD 共享支持信息类型

  • 研究协议
  • 解析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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