Blended psychosocial support for partners of patients with ALS and PMA: results of a randomized controlled trial

<i>Objective:</i> To evaluate whether a blended (face-to-face and online) psychosocial support program for caregivers of patients with Amyotrophic Lateral Sclerosis (ALS) and Progressive Muscular Atrophy (PMA), aimed at enhancing feeling of control over caregiving, reduces psychological distress. <i>Methods:</i> A randomized controlled trial using a wait-list control design was conducted. Caregiver-patient dyads were randomly assigned to either the support program (<i>n</i> = 74) or to a wait-list control group (<i>n</i> = 74). The support program, based on Acceptance and Commitment Therapy, consists of 1 face-to-face contact, 6 online guided modules and 1 telephone contact. Participants filled in questionnaires at baseline, 3 and 6 months. Caregivers’ feeling of control over caregiving was assessed using two self-efficacy measures. Primary outcome was caregivers’ psychological distress. Secondary outcomes included caregiver burden, caregiver quality of life and patients’ quality of life and psychological distress. Intention-to-treat and per-protocol analyses were performed using linear mixed models. <i>Results:</i> The support program had no effect on the primary or secondary outcomes, despite a significant positive effect on the intervening variable self-efficacy with regard to control over thoughts. Almost half of the caregivers did not complete the intervention with the most frequently reported reason being lack of time. Caregivers who completed the intervention evaluated the support program positively. <i>Conclusions:</i> The support program did not reduce distress of partners of patients with ALS/PMA but may be beneficial by increasing feeling of control over the caregiving situation. The high level of intervention drop outs may have limited the ability to detect an intervention effect. <b>Trial registration:</b> Netherlands Trial Registry NTR5734, registered 28 March 2016.<i>研究目标：</i> 旨在评估一项面向肌萎缩侧索硬化症（Amyotrophic Lateral Sclerosis, ALS）与进行性肌萎缩（Progressive Muscular Atrophy, PMA）患者照料者的混合式（线下+线上）心理社会支持项目——其设计初衷为提升照料者的照料掌控感——能否缓解其心理痛苦。<i>研究方法：</i> 本研究采用等待名单对照设计开展随机对照试验。将照料者-患者配对样本随机分配至支持项目组（<i>n</i> = 74）或等待名单对照组（<i>n</i> = 74）。该支持项目基于接纳与承诺疗法（Acceptance and Commitment Therapy, ACT），包含1次线下会面、6个线上指导模块以及1次电话沟通。受试者分别在基线、3个月及6个月时完成问卷填写。照料者的照料掌控感采用两项自我效能感量表进行评估。主要结局指标为照料者的心理痛苦程度；次要结局指标包括照料者负担、照料者生活质量，以及患者的生活质量与心理痛苦程度。本研究采用意向性治疗（intention-to-treat）与符合方案（per-protocol）分析方法，通过线性混合模型（linear mixed models）进行统计检验。<i>研究结果：</i> 尽管该项目对中介变量——思维掌控相关的自我效能感——产生了显著正向影响，但对主要及次要结局指标均未产生显著作用。近半数照料者未完成干预，最常见的未完成原因为缺乏时间。完成全部干预的照料者对该支持项目的评价较为积极。<i>研究结论：</i> 该支持项目未缓解ALS/PMA患者配偶的心理痛苦，但或可通过提升照料者对照料场景的掌控感带来获益。本研究较高的干预脱落率，可能限制了检测干预效应的能力。<b>试验注册：</b> 荷兰试验注册库（Netherlands Trial Registry）NTR5734，注册日期为2016年3月28日。