TY - JOUR
T1 - Effects of a novel, transdiagnostic, hybrid ecological momentary intervention for improving resilience in youth (EMIcompass)
T2 - Protocol for an exploratory randomized controlled Trial
AU - Schick, Anita
AU - Paetzold, Isabell
AU - Rauschenberg, Christian
AU - Hirjak, Dusan
AU - Banaschewski, Tobias
AU - Meyer-Lindenberg, Andreas
AU - Boehnke, Jan
AU - Boecking, Benjamin
AU - Reininghaus, Ulrich
N1 - Funding Information:
This work is funded by a German Research Foundation project grant (#389626655) and German Research Foundation Heisenberg professorship (#389624707) to UR. The sponsor and funding agency do not have any role in the trial design, data collection, statistical analysis, interpretation of data, writing of the manuscript, or the decision to submit reports for publication. AML is supported by German Federal Ministry of Education and Research (BMBF, grant 01EF1803A) Ministry of Science, Research and the Arts of the State of Baden-Wuerttemberg, Germany (MWK, grant 42-5400/136/1); Ministry of Science, Research and the Arts of the State of Baden-Wuerttemberg, Germany (MWK, grant 42-04HV.MED(16)/16/1); and Ministry of Science, Research and the Arts of the State of Baden-Wuerttemberg, Germany (MWK, grant 42-04HV.MED(16)/27/1). The authors are indebted to all individuals who participated, past and present, in the EMIcompass study and are essential for its successful completion. The authors are grateful to Professor Stefan Priebe, Professor Stefan Wellek, Dr Jan R Böhnke, Professor Nicolas Rüsch, Dr Thomas Vaessen, Professor Maria Blettner, Professor Sebastian von Peter, and Professor Georg Schomerus for their membership in the TSC and DMEC, respectively. The authors also thank all trained psychologists (Isabell Paetzold, Dr. Sebastian Butz, and Leonie Schültke) and research assistants.
Publisher Copyright:
©Anita Schick, Isabell Paetzold, Christian Rauschenberg, Dusan Hirjak, Tobias Banaschewski, Andreas Meyer-Lindenberg, Jan R Boehnke, Benjamin Boecking, Ulrich Reininghaus.
PY - 2021/12/3
Y1 - 2021/12/3
N2 - Background: 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.Objective: 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.Methods: 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.Results: 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.Conclusions: 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.Trial Registration: German Clinical Trials Register DRKS00017265; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017265.
AB - Background: 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.Objective: 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.Methods: 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.Results: 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.Conclusions: 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.Trial Registration: German Clinical Trials Register DRKS00017265; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017265.
KW - Experience Sampling Methodology (ESM)
KW - Ecological Momentary Assessment (EMA)
KW - mobile intervention
KW - at-risk individuals
KW - smartphone training
KW - blended care
KW - mental health
KW - stress reactivity
UR - http://www.scopus.com/inward/record.url?scp=85121001106&partnerID=8YFLogxK
U2 - 10.2196/27462
DO - 10.2196/27462
M3 - Article
C2 - 34870613
SN - 1929-0748
VL - 10
JO - JMIR Research Protocols
JF - JMIR Research Protocols
IS - 12
M1 - e27462
ER -