Welzel Franziska D, Löbner Margrit, Quittschalle Janine, Pabst Alexander, Luppa Melanie, Stein Janine, Riedel-Heller Steffi G
Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, Germany.
Internet Interv. 2021 Sep 7;26:100451. doi: 10.1016/j.invent.2021.100451. eCollection 2021 Dec.
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.
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.
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.
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).
亲近之人的离世是晚年生活中压力极大但又很常见的生活事件。虽然大多数人似乎能很好地应对丧亲之痛,但相当一部分老年人会出现长期的悲伤症状。电子心理健康干预已被证明对多种心理疾病有效。然而,专门针对老年人的研究存在很大的空白。本研究方案描述了一项针对60岁及以上成年人丧亲和失落问题的基于互联网的自助干预随机对照试验。自我管理干预基于认知行为疗法技术,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,评估该干预的有效性和可接受性。
AgE-健康研究旨在开展一项随机对照试验。符合条件的60岁及以上参与者将被随机分配到干预组(可使用该干预措施)或积极对照组(可使用阅读疗法)。主要结局是悲伤症状的减轻(13项长期悲伤量表);次要结局包括抑郁、社交活动和社交网络、生活质量、自我效能感、对干预/阅读疗法的满意度、孤独感、可接受性、使用率和依从性。评估将在干预前(基线)以及干预后4个月(随访1)进行。
本研究解决了晚年未得到充分认识和研究的心理健康负担问题,可能会为我们关于电子健康干预对晚年失落和丧亲之痛有效性的认识增添有价值的见解。据我们所知,AgE-健康研究将是第一项评估针对60岁及以上成年人长期悲伤的基于互联网干预措施有效性的随机对照试验。
该研究已在德国临床试验注册中心注册(标识符:DRKS00020595,2020年7月30日注册,https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020595)。