Soendergaard Pernille Langer, Wolffbrandt Mia Moth, Biering-Sørensen Fin, Nordin Malin, Schow Trine, Arango-Lasprilla Juan Carlos, Norup Anne
Department of Neurorehabilitation, TBI Unit, Rigshospitalet, Kettegaard Allé 30, 2650, Hvidovre, Denmark.
Department of Psychology, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark.
Trials. 2019 Nov 27;20(1):646. doi: 10.1186/s13063-019-3794-5.
Acquiring a traumatic injury constitutes a severe life change for the survivor, but also for the surrounding family. The paradigm of helping the family has primarily been on psychosocial interventions targeting caregivers. However, interventions including both survivor and caregivers should be an essential part of treatment, as the whole family's functional level and mental health can be affected. The current study protocol presents a manualized family intervention for families living with traumatic injury to the brain (TBI) or spinal cord (tSCI). The objectives are to investigate if the intervention improves quality of life (QoL) and decreases burden. It is hypothesized that the family intervention improves problem-solving strategies and family dynamics, which will reduce the burden. This may improve the caregivers' mental health, which will improve the support to the survivor and QoL.
The study is an interventional, two-arm, randomized controlled trial. During a 2-year period, a total of 132 families will be included. Participants will be recruited from East-Denmark. Inclusion criteria are (1) TBI or tSCI, (2) ≥ 18 years of age, (3) ≥ 6 months to ≤ 2 years since discharge from hospital, (4) ability to understand and read Danish, (5) cognitive abilities that enable participation, and (6) a minimum of one family member actively involved in the survivor's life. Exclusion criteria are (1) active substance abuse, (2) aphasia, (3) prior neurologic or psychiatric diagnose, and (4) history of violence. Within each disease group, families will be allocated randomly to participate in an intervention or a control group with a ratio 1:1. The intervention groups receive the family intervention consisting of eight sessions of 90 min duration. Families in the control groups receive 2 h of psychoeducation. All participants complete questionnaires on QoL, self-perceived burden, family dynamics, problem-solving strategies, mental health, and resilience at pre-intervention, post-intervention, and 6-month follow up.
If the intervention is found to have effect, the study will contribute with novel knowledge on the use of a manual-based intervention including the entire family. This would be of clinical interest and would help families living with the consequences of TBI or tSCI.
ClinicalTrials.gov, NCT03814876. Retrospectively registered on 24 January 2019.
遭受创伤性损伤不仅对幸存者，而且对其周围的家庭来说，都是一种严重的生活变故。帮助家庭的模式主要是针对照顾者的心理社会干预。然而，包括幸存者和照顾者在内的干预措施应成为治疗的重要组成部分，因为整个家庭的功能水平和心理健康都会受到影响。本研究方案提出了一种针对脑外伤（TBI）或脊髓损伤（tSCI）患者家庭的标准化家庭干预措施。其目的是调查该干预措施是否能提高生活质量（QoL）并减轻负担。研究假设该家庭干预措施能改善解决问题的策略和家庭动态，从而减轻负担。这可能会改善照顾者的心理健康，进而改善对幸存者的支持和生活质量。
本研究为一项干预性、双臂、随机对照试验。在两年时间内，共纳入132个家庭。参与者将从丹麦东部招募。纳入标准为：（1）脑外伤或脊髓损伤；（2）年龄≥18岁；（3）出院后≥6个月至≤2年；（4）具备理解和阅读丹麦语的能力；（5）具备参与研究的认知能力；（6）至少有一名家庭成员积极参与幸存者的生活。排除标准为：（1）有药物滥用；（2）失语症；（3）既往有神经或精神疾病诊断；（4）有暴力史。在每个疾病组内，家庭将以1:1的比例随机分配到干预组或对照组。干预组接受由八节时长90分钟的课程组成的家庭干预。对照组家庭接受2小时的心理教育。所有参与者在干预前、干预后和6个月随访时完成关于生活质量、自我感知负担、家庭动态、解决问题策略、心理健康和心理韧性的问卷调查。
如果发现该干预措施有效，本研究将为使用包括整个家庭的基于手册的干预措施提供新的知识。这将具有临床意义，并有助于脑外伤或脊髓损伤患者的家庭。
ClinicalTrials.gov，NCT03814876。于2019年1月24日追溯注册。
