Cheung Elaine O, Addington Elizabeth L, Bassett Sarah M, Schuette Stephanie A, Shiu Eva W, Cohn Michael A, Leykin Yan, Saslow Laura R, Moskowitz Judith T
Department of Medical Social Sciences, Osher Center for Integrative Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
Department of Psychology and Neuroscience, Duke University, Durham, NC, United States.
JMIR Res Protoc. 2018 Jun 5;7(6):e10494. doi: 10.2196/10494.
Living with elevated symptoms of depression can have debilitating consequences for an individual's psychosocial and physical functioning, quality of life, and health care utilization. A growing body of evidence demonstrates that skills for increasing positive emotion can be helpful to individuals with depression. Although Web-based interventions to reduce negative emotion in individuals with depression are available, these interventions frequently suffer from poor retention and adherence and do not capitalize on the potential benefits of increasing positive emotion.
The aim of this study was to develop and test a Web-based positive emotion skills intervention tailored for individuals living with elevated depressive symptoms, as well as to develop and test enhancement strategies for increasing retention and adherence to that intervention.
This study protocol describes the development and testing for Mobile Affect Regulation Intervention with the Goal of Lowering Depression (MARIGOLD), a Web-based positive emotion skills intervention, adapted for individuals with elevated depressive symptomatology. The intervention development is taking place in three phases. In phase 1, we are tailoring an existing positive emotion skills intervention for individuals with elevated symptoms of depression and are pilot testing the tailored version of the intervention in a randomized controlled trial with two control conditions (N=60). In phase 2, we are developing and testing three enhancements aimed at boosting retention and adherence to the Web-based intervention (N=75): facilitator contact, an online discussion board, and virtual badges. In phase 3, we are conducting a multifactorial, nine-arm pilot trial (N=600) to systematically test these enhancement strategies, individually and in combination. The primary outcome is depressive symptom severity. Secondary outcomes include positive and negative emotion, psychological well-being, and coping resources.
The project was funded in August 2014, and data collection was completed in May 2018. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018.
Findings from this investigation will enable us to develop an optimal package of intervention content and enhancement strategies for individuals with elevated symptoms of depression. If this intervention proves to be effective, it will provide a cost-effective, anonymous, appealing, and flexible approach for reducing symptoms of depression and improving psychological adjustment through increasing positive emotion.
ClinicalTrials.gov NCT01964820 (Phase 1); https://clinicaltrials.gov/ct2/show/NCT01964820 (Archived by WebCite at http://www.webcitation.org/6zpmKBcyX). ClinicalTrials.gov NCT02861755 (Phase 2); https://clinicaltrials.gov/ct2/show/NCT02861755 (Archived by WebCite at http://www.webcitation.org/6zpmLmy8k).
RR1-10.2196/10494.
长期处于抑郁症状加重的状态会对个体的心理社会功能、身体机能、生活质量以及医疗保健利用产生严重的不良后果。越来越多的证据表明,提升积极情绪的技能对抑郁症患者有所帮助。虽然有基于网络的干预措施可用于减轻抑郁症患者的负面情绪,但这些干预措施常常存在留存率低和依从性差的问题,且未充分利用提升积极情绪可能带来的益处。
本研究旨在开发并测试一种专门为抑郁症状加重的个体量身定制的基于网络的积极情绪技能干预措施,同时开发并测试提高该干预措施留存率和依从性的强化策略。
本研究方案描述了“以降低抑郁为目标的移动情绪调节干预”(MARIGOLD)的开发与测试过程,这是一种基于网络的积极情绪技能干预措施,适用于抑郁症状加重的个体。干预措施的开发分三个阶段进行。在第一阶段,我们正在为抑郁症状加重的个体量身定制现有的积极情绪技能干预措施,并在一项设有两种对照条件的随机对照试验中对该定制版干预措施进行试点测试(N = 60)。在第二阶段,我们正在开发并测试三种旨在提高对基于网络干预措施的留存率和依从性的强化措施(N = 75):辅导员联系、在线讨论板和虚拟徽章。在第三阶段,我们正在进行一项多因素、九组的试点试验(N = 600),以系统地单独或组合测试这些强化策略。主要结局是抑郁症状的严重程度。次要结局包括积极和消极情绪、心理健康以及应对资源。
该项目于2014年8月获得资助,数据收集于2018年5月完成。目前正在进行数据分析,预计首批结果将于2018年提交发表。
本调查的结果将使我们能够为抑郁症状加重的个体开发出一套最佳的干预内容和强化策略组合。如果该干预措施被证明是有效的,它将提供一种经济高效、匿名、有吸引力且灵活的方法,通过增加积极情绪来减轻抑郁症状并改善心理调适。
ClinicalTrials.gov NCT01964820(第一阶段);https://clinicaltrials.gov/ct2/show/NCT01964820(由WebCite存档于http://www.webcitation.org/6zpmKBcyX)。ClinicalTrials.gov NCT02861755(第二阶段);https://clinicaltrials.gov/ct2/show/NCT02861755(由WebCite存档于http://www.webcitation.org/6zpmLmy8k)。
RR1 - 10.2196/10494。