一项基于正念的移动应用程序在门诊治疗抑郁症中的有效性：一项随机对照试验的方案

Effectiveness of a Mindfulness-Based Mobile Application for the Treatment of Depression in Ambulatory Care: Protocol for a Randomized Controlled Trial.

作者信息

Sarlon Jan, Doll Jessica P K, Schmassmann Aline, Brand Serge, Ferreira Naomi, Muehlhauser Markus, Urech-Meyer Stefanie, Schweinfurth Nina, Lang Undine Emmi, Bruehl Annette Beatrix

机构信息

University Psychiatric Clinics, University of Basel, Basel, Switzerland.

Department of Sport, Exercise and Health, Faculty of Medicine, University of Basel, Basel, Switzerland.

出版信息

JMIR Res Protoc. 2022 Mar 31;11(3):e33423. doi: 10.2196/33423.

DOI:10.2196/33423

PMID:35357325

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9015747/

Abstract

BACKGROUND

Patients with major depressive disorder (MDD) often experience relapses despite regular treatment with pharmacotherapy and psychotherapy. Further, long waiting lists and more demand than treatment capacity characterize ambulatory settings. Mindfulness-based interventions proved to be effective in relapse prevention in MDD. Next, mindfulness-based interventions in the form of free mobile applications can be an effective augmentation of the treatment as usual and can fill a gap in ambulatory care.

OBJECTIVE

Given this background, the aim of this randomized controlled study is to assess the effectiveness of additional MBI via a mobile app on the symptom severity and stress levels, compared to treatment as usual.

METHODS

A total of 140 individuals with MDD will be randomly allocated to the intervention or control condition. The intervention consists of the daily use of the mindfulness mobile application Headspace for thirty days (up to 10 minutes a day). The control condition will be treatment as usual. At baseline and four weeks later, the following key outcome dimensions will be assessed: self-rated (Beck Depression Inventory) and experts' rated symptoms of MDD (Hamilton Depression Rating Scale); secondary outcome variables will be blood pressure, heart rate, and respiratory rate and changes in tobacco and alcohol consumption and medication as a proxy of perceived stress.

RESULTS

This study was funded in February 2021 and approved by the institutional review board on April 15, 2021, and it started in May 2021. As of December 2021, we enrolled 30 participants. The findings are expected to be published in spring 2023.

CONCLUSIONS

We hypothesize that compared to the control conditions, individuals with MDD of the mobile app-condition will have both lower self- and experts' rated symptoms of MDD and more favorable stress-related levels. While the risk for medical events is low, the immediate benefit for participants could be a decrease in symptom severity and reduction of the stress level.

TRIAL REGISTRATION

Clinical Trials.gov NCT05060393; https://clinicaltrials.gov/ct2/show/NCT05060393.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33423.

摘要

背景

尽管接受了药物治疗和心理治疗，但重度抑郁症（MDD）患者仍经常复发。此外，门诊环境的特点是等待名单长，需求超过治疗能力。基于正念的干预措施已被证明在预防MDD复发方面有效。其次，以免费移动应用程序形式提供的基于正念的干预措施可以有效地增强常规治疗，并填补门诊护理的空白。

目的

鉴于此背景，本随机对照研究的目的是评估通过移动应用程序进行额外的正念减压疗法（MBI）与常规治疗相比，对症状严重程度和压力水平的有效性。

方法

总共140名MDD患者将被随机分配到干预组或对照组。干预措施包括每天使用正念移动应用程序Headspace，持续30天（每天最多10分钟）。对照组将接受常规治疗。在基线和四周后，将评估以下关键结局指标：自评（贝克抑郁量表）和专家评定的MDD症状（汉密尔顿抑郁评定量表）；次要结局变量将是血压、心率、呼吸频率以及烟草和酒精消费及药物使用的变化，作为感知压力的指标。