Schick Anita, Paetzold Isabell, Rauschenberg Christian, Hirjak Dusan, Banaschewski Tobias, Meyer-Lindenberg Andreas, Boehnke Jan R, Boecking Benjamin, Reininghaus Ulrich
Department of Public Mental Health, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
JMIR Res Protoc. 2021 Dec 3;10(12):e27462. doi: 10.2196/27462.
Most mental disorders first emerge in youth and, in their early stages, surface as subthreshold expressions of symptoms comprising a transdiagnostic phenotype of psychosis, mania, depression, and anxiety. Elevated stress reactivity is one of the most widely studied mechanisms underlying psychotic and affective mental health problems. Thus, targeting stress reactivity in youth is a promising indicated and translational preventive strategy for adverse mental health outcomes that could develop later in life and for improving resilience. Compassion-focused interventions offer a wide range of innovative therapeutic techniques that are particularly amenable to being implemented as ecological momentary interventions (EMIs), a specific type of mobile health intervention, to enable youth to access interventions in a given moment and context in daily life. This approach may bridge the current gap in youth mental health care.
This study aims to investigate the clinical feasibility, candidate underlying mechanisms, and initial signals of the efficacy of a novel, transdiagnostic, hybrid EMI for improving resilience to stress in youth-EMIcompass.
In an exploratory randomized controlled trial, youth aged between 14 and 25 years with current distress, a broad Clinical High At-Risk Mental State, or the first episode of a severe mental disorder will be randomly allocated to the EMIcompass intervention (ie, EMI plus face-to-face training sessions) in addition to treatment as usual or a control condition of treatment as usual only. Primary (stress reactivity) and secondary candidate mechanisms (resilience, interpersonal sensitivity, threat anticipation, negative affective appraisals, and momentary physiological markers of stress reactivity), as well as primary (psychological distress) and secondary outcomes (primary psychiatric symptoms and general psychopathology), will be assessed at baseline, postintervention, and at the 4-week follow-up.
The first enrollment was in August 2019, and as of May 2021, enrollment and randomization was completed (N=92). We expect data collection to be completed by August 2021.
This study is the first to establish feasibility, evidence on underlying mechanisms, and preliminary signals of the efficacy of a compassion-focused EMI in youth. If successful, a confirmatory randomized controlled trial will be warranted. Overall, our approach has the potential to significantly advance preventive interventions in youth mental health provision.
German Clinical Trials Register DRKS00017265; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017265.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27462.
大多数精神障碍首次出现在青少年时期，在早期阶段，表现为构成精神病、躁狂症、抑郁症和焦虑症跨诊断表型的症状的阈下表达。应激反应性升高是精神病性和情感性心理健康问题最广泛研究的潜在机制之一。因此，针对青少年的应激反应性是一种有前景的、针对可能在以后生活中出现的不良心理健康结果以及提高恢复力的指示性和转化性预防策略。以同情为中心的干预提供了广泛的创新治疗技术，特别适合作为生态瞬时干预（EMI）实施，这是一种特定类型的移动健康干预，使青少年能够在日常生活中的特定时刻和情境中获得干预。这种方法可能弥合当前青少年心理健康护理的差距。
本研究旨在调查一种新型的、跨诊断的混合EMI（EMIcompass）对提高青少年应激恢复力的临床可行性、潜在机制及疗效的初步信号。
在一项探索性随机对照试验中，年龄在14至25岁之间、目前有困扰、处于广泛的临床高风险精神状态或患有严重精神障碍首发的青少年将被随机分配到EMIcompass干预组（即EMI加面对面培训课程），同时接受常规治疗或仅接受常规治疗的对照条件。主要（应激反应性）和次要候选机制（恢复力、人际敏感性、威胁预期、负面情感评估和应激反应性的瞬时生理指标），以及主要（心理困扰）和次要结果（主要精神症状和一般精神病理学），将在基线、干预后和4周随访时进行评估。
首次入组时间为2019年8月，截至2021年5月，入组和随机分组已完成（N = 92）。我们预计数据收集将于2021年8月完成。
本研究首次证实了以同情为中心的EMI在青少年中的可行性、潜在机制证据及疗效的初步信号。如果成功，将有必要进行一项验证性随机对照试验。总体而言，我们的方法有可能显著推进青少年心理健康预防干预。
德国临床试验注册中心DRKS00017265；https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017265。
国际注册报告识别码（IRRID）：DERR1-10.2196/27462。
