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一项针对有焦虑症状的老年人的基于互联网的接纳与承诺疗法干预:一项整群随机对照试验的研究方案

An Internet-based Acceptance and Commitment Therapy intervention for older adults with anxiety complaints: study protocol for a cluster randomized controlled trial.

作者信息

Witlox Maartje, Kraaij Vivivan, Garnefski Nadia, de Waal Margot W M, Smit Filip, Hoencamp Erik, Gussekloo Jacobijn, Bohlmeijer Ernst T, Spinhoven Philip

机构信息

Institute of Psychology, Leiden University, Leiden, The Netherlands.

Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.

出版信息

Trials. 2018 Sep 17;19(1):502. doi: 10.1186/s13063-018-2731-3.

Abstract

BACKGROUND

Anxiety is among the most prevalent and disabling mental health problems in older adults. Few older adults with mild to moderately severe anxiety symptoms receive adequate interventions, putting them at risk for developing anxiety disorders, depression, and various somatic problems. Effective, low-threshold interventions should be developed. Blended care, in which a web-based intervention is combined with a limited amount of face-to-face contacts with a mental healthcare counselor at the general practice, is a promising option. The online self-help intervention "Living to the Full"-an Acceptance and Commitment Therapy (ACT) intervention-has been proven to reduce depression and anxiety in several patient groups, but has not yet been investigated in older adults. The aim of this study is to evaluate the (cost-)effectiveness of a blended form of "Living to the Full" in reducing anxiety symptoms in adults aged 55 to 75 years. Furthermore, moderators and mediators of the treatment effect are investigated.

METHODS/DESIGN: The (cost-)effectiveness of the ACT intervention will be investigated in a cluster single-blind randomized controlled trial (RCT). The blended intervention will be compared to treatment-as-usual. Thirty-six mental health counselors working at general practices in the Netherlands will be randomized to deliver blended care or treatment as usual. A total of 240 participants (aged 55-75 years) with mild to moderately severe anxiety complaints (defined as a total score of 5-15 on the GAD-7) will be recruited. There are four measurements consisting of online questionnaires (primary outcome: GAD-7) and a telephone interview: before the start of the intervention; directly following the intervention (14 weeks after baseline); and six and twelve months after baseline. Possible mediator variables will be assessed multiple times basis during the intervention.

DISCUSSION

This RCT will evaluate the effectiveness of a blended ACT intervention for older adults with anxiety symptoms. If the intervention is shown to be effective, it will be implemented, thereby improving the accessibility and quality of preventive interventions for older adults with anxiety problems.

TRIAL REGISTRATION

Netherlands Trial Register, NTR6270 . Registered on 21 March 2017.

摘要

背景

焦虑是老年人中最普遍且致残的心理健康问题之一。很少有轻度至中度严重焦虑症状的老年人能得到充分干预,这使他们有患焦虑症、抑郁症及各种躯体问题的风险。应开发有效的低门槛干预措施。混合式照护是一种很有前景的选择,即基于网络的干预与在全科医疗中与心理保健顾问进行有限次数的面对面接触相结合。在线自助干预“充分生活”——一种接受与承诺疗法(ACT)干预——已被证明能减轻多个患者群体的抑郁和焦虑,但尚未在老年人中进行研究。本研究的目的是评估“充分生活”的混合形式在减轻55至75岁成年人焦虑症状方面的(成本)效益。此外,还将研究治疗效果的调节因素和中介因素。

方法/设计:将在一项整群单盲随机对照试验(RCT)中研究ACT干预的(成本)效益。将混合式干预与常规治疗进行比较。荷兰36名在全科医疗工作的心理健康顾问将被随机分配提供混合式照护或常规治疗。总共将招募240名(年龄在55 - 75岁之间)有轻度至中度严重焦虑主诉(定义为在广泛性焦虑障碍量表-7上的总分5 - 15分)的参与者。有四项测量,包括在线问卷(主要结局:广泛性焦虑障碍量表-7)和一次电话访谈:在干预开始前;干预结束后立即(基线后14周);以及基线后6个月和12个月。在干预期间将多次评估可能的中介变量。

讨论

这项随机对照试验将评估混合式ACT干预对有焦虑症状老年人的有效性。如果该干预被证明有效,将会实施,从而提高针对有焦虑问题老年人的预防性干预的可及性和质量。

试验注册

荷兰试验注册库,NTR6270。于2017年3月21日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a6e/6142346/64ccaa3d64e7/13063_2018_2731_Fig1_HTML.jpg

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