球毯对门诊抑郁症患者失眠的疗效：一项随机交叉多中心试验的研究方案。

The efficacy of ball blankets on insomnia in depression in outpatient clinics: study protocol for a randomized crossover multicentre trial.

机构信息

Research Unit of Nursing and Healthcare, Department of Public Health, Aarhus University, Bartholins Allé 2, Aarhus C and Protac A/S, Niels Bohrs Vej 31D, 8660, Skanderborg, Denmark.

Center for Neuropsychiatric Depression Research, Mental Health Centre Glostrup, Glostrup, Denmark.

出版信息

Trials. 2020 Aug 17;21(1):720. doi: 10.1186/s13063-020-04638-y.

DOI:10.1186/s13063-020-04638-y

PMID:32807208

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7430021/

Abstract

BACKGROUND

Depression affects approx. 4% of the global population and is often accompanied by insomnia. Medications used to treat insomnia can have side effects such as development of tolerance and addiction. The Protac Ball Blanket™ (PBB) is a non-pharmacological supplement to sedatives and hypnotics, but evidence for the efficacy of PBB is needed before the treatment is implemented. The objective of this trial is to test the efficacy of PBB on insomnia caused by depression in a randomized controlled design.

METHODS

This study is a multicentre, randomized crossover trial with planned inclusion of 45 patients. The randomization procedure is permuted-block randomization with varying block sizes. Patients are allocated into either a sequence "AB" or "BA" each lasting 4 weeks (28 nights). Patients randomized to the "AB" sequence receive treatment A (Protac Ball Blanket™) in the first 2 weeks and switch to treatment B (treatment as usual) in the second period, whereas patients who are randomized to the BA sequence receive treatment B in the first period and treatment A in the second period. The participants will serve as their own control in this design. The primary outcome is changes in total sleep time. Secondary outcome measures are changes in sleep onset latency, number of awakenings, wake after sleep onset, and use of sedatives and hypnotics. Furthermore, quality of sleep, insomnia severity status, and self-reported symptoms of depression, anxiety, interpersonal sensitivity, and neurasthenia will be measured. A paired, two-sided t test to compare the means of the differences in the outcomes will be performed.

DISCUSSION

This clinical trial will assess the effect of PBB on depression-related insomnia. The outcomes are of high interest as the PBB is a potential non-pharmacological supplement to medical treatment of patients with insomnia due to depression.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03730974 . Registered on 5 November 2018.

摘要

背景

抑郁症影响全球约 4%的人口，常伴有失眠。用于治疗失眠的药物可能有副作用，如产生耐受性和成瘾性。Protac 球毯（PBB）是镇静剂和催眠剂的非药物补充剂，但在实施治疗之前，需要有证据证明 PBB 的疗效。本试验的目的是在随机对照设计中测试 PBB 对抑郁症引起的失眠的疗效。

方法

这是一项多中心、随机交叉试验，计划纳入 45 名患者。随机程序是采用变化大小的区组随机化。患者被分配到序列“AB”或“BA”中，每个序列持续 4 周（28 晚）。随机分配到“AB”序列的患者在前 2 周接受治疗 A（Protac 球毯），然后在第二阶段切换到治疗 B（常规治疗），而随机分配到 BA 序列的患者在前一阶段接受治疗 B，在后一阶段接受治疗 A。在这种设计中，参与者将作为自己的对照。主要结局是总睡眠时间的变化。次要结局测量是入睡潜伏期、觉醒次数、睡眠后觉醒、镇静剂和催眠剂的使用情况。此外，还将测量睡眠质量、失眠严重程度以及自我报告的抑郁、焦虑、人际敏感和神经衰弱症状。将采用配对、双侧 t 检验比较结局差异的均值。