Brodbeck Jeannette, Berger Thomas, Znoj Hans Joerg
Department of Psychology, University of Bern, Fabrikstrasse 8, 3012, Bern, Switzerland.
Trials. 2017 Jan 13;18(1):21. doi: 10.1186/s13063-016-1759-5.
Marital bereavement and separation or divorce are among the most stressful critical life events in later life. These events require a dissolution of social and emotional ties, adjustments in daily routine and changes in identity and perspectives for the future. After a normative grief or distress reaction, most individuals cope well with the loss. However, some develop a prolonged grief reaction. Internet-based self-help interventions have proved beneficial for a broad range of disorders, including complicated grief. Based on the task model and the dual-process model of coping with bereavement, we developed a guided internet-based self-help intervention for individuals who experienced marital bereavement, separation or divorce at least 6 months prior to enrolment. The intervention consists of 10 text-based self-help sessions and one supportive email a week. The primary purpose of this study is the evaluation of the feasibility and efficacy of the intervention compared with a waiting control group. The secondary purpose is to compare the effects in bereaved and separated participants. Furthermore, we aim to analyze other predictors, moderators and mediators of the outcome, such as age, psychological distress and intensity of use of the intervention.
The design is a randomized controlled trial with a waiting control condition of 12 weeks and a 24-weeks follow-up. At least 72 widowed or separated participants will be recruited via our study website and internet forums. Primary outcomes are reductions in grief symptoms, depression and psychological distress. Secondary outcome measures are related to loneliness, satisfaction with life, embitterment and the sessions.
The trial will provide insights into the acceptance and efficacy of internet-based interventions among adults experiencing grief symptoms, psychological distress and adaptation problems in daily life after spousal bereavement, separation or divorce. Findings will add to existing knowledge by (1) evaluating an internet-based intervention specifically designed for spousal bereavement and its consequences; (2) testing whether this intervention is equally effective for individuals after separation or divorce; and (3) suggesting adaptations to improve the efficacy of the intervention, selective indication and adaptations for different needs.
ClinicalTrials.gov, NCT02900534 . Registered on 1 September 2016.
配偶丧亡、分居或离婚是晚年生活中压力最大的重大生活事件之一。这些事件需要解除社会和情感纽带，调整日常生活，改变身份认同和对未来的看法。在经历正常的悲伤或痛苦反应后，大多数人能够很好地应对这种丧失。然而，有些人会出现延长的悲伤反应。基于网络的自助干预已被证明对包括复杂性悲伤在内的多种疾病有益。基于应对丧亲之痛的任务模型和双过程模型，我们为在入组前至少6个月经历过配偶丧亡、分居或离婚的个体开发了一种基于网络的引导式自助干预。该干预包括10次基于文本的自助课程和每周一封支持性电子邮件。本研究的主要目的是评估该干预与等待对照组相比的可行性和有效性。次要目的是比较丧亲者和分居者的效果。此外，我们旨在分析其他结果预测因素、调节因素和中介因素，如年龄、心理困扰和干预使用强度。
本设计为一项随机对照试验，设置12周的等待对照期和24周的随访期。将通过我们的研究网站和网络论坛招募至少72名丧偶或分居的参与者。主要结局是悲伤症状、抑郁和心理困扰的减轻。次要结局指标与孤独感、生活满意度、痛苦感和课程有关。
该试验将深入了解基于网络的干预在经历配偶丧亡、分居或离婚后出现悲伤症状、心理困扰和日常生活适应问题的成年人中的接受度和有效性。研究结果将通过以下方式增加现有知识：（1）评估专门为配偶丧亡及其后果设计的基于网络的干预；（2）测试该干预对分居或离婚后的个体是否同样有效；（3）提出改进干预效果、进行选择性适应症选择和针对不同需求进行调整的建议。
ClinicalTrials.gov，NCT02900534。于2016年9月1日注册。
