设想你的情绪：一项随机对照微型试验的研究设计与方案，该试验采用基于应用程序的经验抽样方法，以探索复发性抑郁症预防复发干预期间的变化过程。
Imagine your mood: Study design and protocol of a randomized controlled micro-trial using app-based experience sampling methodology to explore processes of change during relapse prevention interventions for recurrent depression.
作者信息
Slofstra Christien, Klein Nicola S, Nauta Maaike H, Wichers Marieke, Batalas Nikolaos, Bockting Claudi L H
机构信息
Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, 9712 TS, Groningen, The Netherlands.
University of Groningen, University Medical Center Groningen (UMCG), Department of Psychiatry (UCP), Interdisciplinary Center for Psychopathology and Emotion Regulation (ICPE), 9700 RB, Groningen, The Netherlands.
出版信息
Contemp Clin Trials Commun. 2017 Jul 12;7:172-178. doi: 10.1016/j.conctc.2017.07.003. eCollection 2017 Sep.
BACKGROUND
Relapse prevention strategies include continuation of antidepressant medication and preventive psychological interventions. This study aims to gain understanding that may inform tailoring of relapse prevention to individual differences, to improve their effects. Such treatment personalization may be based on repeated assessments within one individual, using experience sampling methodology. As a first step towards informing decisions based on this methodology, insight is needed in individual differences in risk of relapse and response to treatment, and how relapse prevention strategies may differentially target vulnerability for relapse.
METHODS
The smartphone application 'Imagine your mood' has been developed specifically for this study to assess emotions, imagery, cognitions, and behaviors in daily life. Parallel to the randomized controlled trial 'Disrupting the rhythm of depression', 45 remitted recurrently depressed individuals taking continuation antidepressant medication will be randomly assigned to either continuing antidepressant medication ( = 15), continuing antidepressant medication combined with an eight-session preventive cognitive therapy ( = 15), or tapering of antidepressant medication in combination with preventive cognitive therapy ( = 15). Relapse and return of depressive symptomatology over a 24-month follow-up will be assessed. Additionally, matched never depressed individuals ( = 15) will be recruited as controls.
DISCUSSION
This innovative study combines the strengths of a randomized controlled trial and experience sampling methodology in a micro-trial to explore individual differences in risk of relapse and what works for whom to prevent relapse. Results may ultimately pave the way for therapists to tailor relapse prevention strategies to individual (affective) vulnerability.
TRIAL REGISTRATION
ISRCTN15472145, retrospectively registered.
背景
预防复发策略包括继续使用抗抑郁药物和进行预防性心理干预。本研究旨在深入了解如何根据个体差异调整预防复发措施，以提高其效果。这种治疗个性化可以基于使用经验抽样方法对个体进行反复评估。作为基于该方法做出决策的第一步，需要了解复发风险和治疗反应的个体差异，以及预防复发策略如何以不同方式针对复发易感性。
方法
专门为该研究开发了智能手机应用程序“想象你的情绪”，以评估日常生活中的情绪、意象、认知和行为。与随机对照试验“打破抑郁节奏”并行，45名正在服用维持性抗抑郁药物的缓解期复发性抑郁症患者将被随机分配到继续服用抗抑郁药物组（n = 15）、继续服用抗抑郁药物并结合八节预防性认知治疗组（n = 15）或逐渐减少抗抑郁药物剂量并结合预防性认知治疗组（n = 15）。将评估24个月随访期间的复发情况和抑郁症状的复发。此外，将招募15名匹配的从未患过抑郁症的个体作为对照。
讨论
这项创新性研究将随机对照试验和经验抽样方法的优势结合在一个微型试验中，以探索复发风险的个体差异以及何种方法对预防复发有效。研究结果最终可能为治疗师根据个体（情感）易感性调整预防复发策略铺平道路。
试验注册
ISRCTN15472145，回顾性注册。
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