Background

The death of a close person is a highly stressful, yet common life event in later life. While most individuals seem to cope well with bereavement, a substantial proportion of older individuals suffer from prolonged grief symptoms. E-mental health interventions have been shown to be efficient for a variety of psychological illnesses. Yet, there is a large research gap of studies with a special focus on older adults. This study protocol describes a randomized controlled trial for an internet-based self-help intervention addressing bereavement and loss in adults aged 60 years and over. The self-management intervention is based on techniques of cognitive behavioral therapy and consists of 8 modules. The objective of the AgE-health study is to evaluate the effectiveness and acceptability of this intervention in comparison to a bibliotherapy control group.

Methods

The AgE-health study aims at implementing a randomized controlled trial. Eligible participants aged 60+ years will be randomly allocated to an intervention group (access to the intervention) or to an active control group (access to bibliotherapy). Primary outcome is the reduction in grief symptoms (13-item Prolonged Grief Inventory); secondary outcomes are depression, social activity and network, quality of life, self-efficacy, satisfaction with the intervention/bibliotherapy, loneliness, acceptability, up-take and adherence. Assessments will take place before the intervention (baseline) as well as 4 months (follow-up 1) after the intervention.

Discussion

This study addresses an under-recognized and understudied mental health burden in later life and may add valuable insight into our knowledge about the effectiveness of eHealth interventions for loss and bereavement in late life. To our knowledge, the AgE-health study will be the first randomized controlled trial to evaluate the effectiveness of an internet-based intervention targeting prolonged grief in adults aged 60 years and over.

Trial registration

The study has been registered at the German Clinical Trials Register (Identifier: DRKS00020595, Registered 30th July 2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020595).

中文翻译：

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晚年的失落和丧亲之痛（60 岁以上）：关于基于互联网的自助干预的随机对照试验的研究方案

 背景

亲密之人的去世是晚年生活中一件压力很大但又常见的事件。虽然大多数人似乎都能很好地应对丧亲之痛，但相当一部分老年人患有长期悲伤症状。电子心理健康干预措施已被证明对多种心理疾病有效。然而，特别关注老年人的研究存在很大的研究空白。本研究方案描述了一项基于互联网的自助干预的随机对照试验，旨在解决 60 岁及以上成年人的丧亲和损失问题。自我管理干预以认知行为治疗技术为基础，由 8 个模块组成。 AgE-健康研究的目的是与阅读疗法对照组相比，评估这种干预措施的有效性和可接受性。

 方法

AgE-健康研究旨在实施一项随机对照试验。 60 岁以上符合资格的参与者将被随机分配到干预组（接受干预）或主动对照组（接受阅读疗法）。主要结局是悲伤症状的减轻（13 项长期悲伤量表）；次要结果是抑郁、社交活动和网络、生活质量、自我效能、对干预/阅读疗法的满意度、孤独感、可接受性、接受度和依从性。评估将在干预前（基线）以及干预后 4 个月（随访 1）进行。

 讨论

这项研究解决了晚年生活中未被充分认识和研究的心理健康负担，并可能为我们关于电子健康干预措施对晚年损失和丧亲之痛的有效性的了解提供宝贵的见解。据我们所知，AgE-健康研究将是第一个随机对照试验，旨在评估针对 60 岁及以上成年人长期悲伤的基于互联网的干预措施的有效性。

 试用注册

该研究已在德国临床试验注册处注册（标识符：DRKS00020595，注册于2020年7月30日，https://www.drks.de/drks_web/navigate.do?navigationId=Trial.HTML&TRIAL_ID=DRKS00020595）。