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丹麦创伤后应激障碍退伍军人的身体疗法与常规治疗对比:一项结合定性研究的随机对照试验研究方案

Body therapy versus treatment as usual among Danish veterans with PTSD: Study protocol for a randomised controlled trial combined with a qualitative study.

作者信息

Ahlmark Nanna Gram, Dahl Anders, Andersen Henrik Steen, Tjørnhøj-Thomsen Tine, Andersen Susan

机构信息

National Institute of Public Health, University of Southern Denmark, Studiestræde 6, DK-1455, Copenhagen, Denmark.

Danish Military Psychiatric Center, Capital Region of Denmark, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.

出版信息

Contemp Clin Trials Commun. 2020 Jun 20;19:100596. doi: 10.1016/j.conctc.2020.100596. eCollection 2020 Sep.

Abstract

BACKGROUND

Many veterans suffer from Post-Traumatic Stress Disorder (PTSD) after returning from military missions. This implies complex physical and psychosocial problems for veterans and their families. Treatment options today are primarily medically and psychologically founded but treatment response is incomplete. Body therapy for PTSD is scarcely researched though subject of increased attention. In 2015, a Danish pilot study was conducted exploring body therapy for PTSD. The study showed positive results and formed basis for a randomised controlled trial. This paper outlines the protocol for this trial.

METHODS

The intervention will be evaluated in a two-arm randomised controlled trial (1:1). The trial will include 42 veterans with PTSD recruited by the Danish Military Psychiatric Centre. The intervention group receives treatment as usual and weekly body therapy treatment as add-on. The control group receives treatment as usual (TAU). Participants will complete four questionnaires assessing PTSD, depression, quality of life, function level and body awareness: at baseline, and at 3 months, 6 months and 12 months post baseline. Linear regression models and mixed effects models will be used to assess intervention effects. Furthermore, an ethnographic study will examine how the participants experience the treatment and changes in their everyday life. The ethnographic study is based on in-depth interviews, participant observations and focus groups. A mixed method, convergent parallel design will be applied.

DISCUSSION

This study examines the efficacy of body therapy for veterans with PTSD and how the treatment is experienced and affects daily life. The study will contribute with important knowledge on an alternative treatment for PTSD.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03777800.

摘要

背景

许多退伍军人在执行军事任务回国后患有创伤后应激障碍(PTSD)。这给退伍军人及其家庭带来了复杂的身体和心理社会问题。目前的治疗选择主要基于医学和心理学,但治疗反应并不完全。尽管对PTSD的身体疗法关注度不断提高,但相关研究却很少。2015年,丹麦进行了一项探索PTSD身体疗法的试点研究。该研究显示出积极的结果,并为一项随机对照试验奠定了基础。本文概述了该试验的方案。

方法

该干预措施将在一项双臂随机对照试验(1:1)中进行评估。该试验将纳入42名由丹麦军事精神病中心招募的患有PTSD的退伍军人。干预组接受常规治疗并每周额外接受身体疗法治疗。对照组接受常规治疗(TAU)。参与者将在基线时以及基线后3个月、6个月和12个月完成四份评估PTSD、抑郁、生活质量、功能水平和身体意识的问卷。将使用线性回归模型和混合效应模型来评估干预效果。此外,一项人种学研究将考察参与者如何体验治疗以及他们日常生活中的变化。该人种学研究基于深入访谈、参与观察和焦点小组。将采用混合方法、收敛平行设计。

讨论

本研究考察了身体疗法对患有PTSD的退伍军人的疗效,以及这种治疗的体验方式和对日常生活的影响。该研究将为PTSD的替代治疗提供重要知识。

试验注册

ClinicalTrials.gov标识符:NCT03777800。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81cf/7322676/554f843ef06b/gr1.jpg

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