Effects of a novel, transdiagnostic ecological momentary intervention for prevention and early intervention of severe mental disorder in youth (EMIcompass): findings from an exploratory randomized controlled trial

TY - JOUR

T1 - Effects of a novel, transdiagnostic ecological momentary intervention for prevention and early intervention of severe mental disorder in youth (EMIcompass)

T2 - findings from an exploratory randomized controlled trial

AU - Reininghaus, Ulrich

AU - Paetzold, Isabell

AU - Rauschenberg, Christian

AU - Hirjak, Dusan

AU - Banaschewski, Tobias

AU - Meyer-Lindenberg, Andreas

AU - Boehnke, Jan R.

AU - Boecking, Benjamin

AU - Schick, Anita

N1 - Funding Information: This work was funded by a DFG project grant (no. 389626655) and DFG Heisenberg professorship (no. 389624707) to UR. Copyright: © The Author(s) 2023. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: [email protected]

PY - 2023/5

Y1 - 2023/5

N2 - Background/Hypothesis: Digital interventions targeting transdiagnostic mechanisms in daily life may be a promising translational strategy for prevention and early intervention of psychotic and other severe mental disorders. We aimed to investigate the feasibility and initial signals of efficacy of a transdiagnostic, compassion-focused, hybrid ecological momentary intervention for improving resilience (ie, EMIcompass) in youth with early mental health problems. Study Design: In an exploratory, assessor-blind randomized controlled trial, youth aged 14–25 with current distress, broad at-risk mental state, or first episode of severe mental disorder were randomly allocated to experimental (EMIcompass+treatment as usual [TAU]) or control condition (TAU). Data on primary (stress reactivity) and secondary candidate mechanisms as well as candidate primary (psychological distress) and secondary outcomes were collected. Study Results: Criteria for the feasibility of trial methodology and intervention delivery were met (n = 92 randomized participants). No serious adverse events were observed. Initial outcome signals were evident for reduced momentary stress reactivity (stress×time×condition, B = −0.10 95%CI −0.16–−0.03, d = −0.10), aberrant salience (condition, B = −0.38, 95%CI −0.57–−0.18, d = −0.56) as well as enhanced momentary resilience (condition, B = 0.55, 95%CI 0.18–0.92, d = 0.33) and quality of life (condition, B = 0.82, 95%CI 0.10–1.55, d = 0.60) across post-intervention and 4-week follow-up. No outcome signals were observed for self-reported psychological distress (condition, B = 0.57, 95%CI −1.59–2.72, d = 0.09), but there was suggestive evidence of reduced observer-rated symptoms at the 4-week follow-up (B = −1.41, 95%CI −2.85–0.02, d = −0.41). Conclusions: Our findings provide evidence of feasibility and initial signals that EMIcompass may reduce stress reactivity and improve quality of life. A definitive trial is now warranted.

AB - Background/Hypothesis: Digital interventions targeting transdiagnostic mechanisms in daily life may be a promising translational strategy for prevention and early intervention of psychotic and other severe mental disorders. We aimed to investigate the feasibility and initial signals of efficacy of a transdiagnostic, compassion-focused, hybrid ecological momentary intervention for improving resilience (ie, EMIcompass) in youth with early mental health problems. Study Design: In an exploratory, assessor-blind randomized controlled trial, youth aged 14–25 with current distress, broad at-risk mental state, or first episode of severe mental disorder were randomly allocated to experimental (EMIcompass+treatment as usual [TAU]) or control condition (TAU). Data on primary (stress reactivity) and secondary candidate mechanisms as well as candidate primary (psychological distress) and secondary outcomes were collected. Study Results: Criteria for the feasibility of trial methodology and intervention delivery were met (n = 92 randomized participants). No serious adverse events were observed. Initial outcome signals were evident for reduced momentary stress reactivity (stress×time×condition, B = −0.10 95%CI −0.16–−0.03, d = −0.10), aberrant salience (condition, B = −0.38, 95%CI −0.57–−0.18, d = −0.56) as well as enhanced momentary resilience (condition, B = 0.55, 95%CI 0.18–0.92, d = 0.33) and quality of life (condition, B = 0.82, 95%CI 0.10–1.55, d = 0.60) across post-intervention and 4-week follow-up. No outcome signals were observed for self-reported psychological distress (condition, B = 0.57, 95%CI −1.59–2.72, d = 0.09), but there was suggestive evidence of reduced observer-rated symptoms at the 4-week follow-up (B = −1.41, 95%CI −2.85–0.02, d = −0.41). Conclusions: Our findings provide evidence of feasibility and initial signals that EMIcompass may reduce stress reactivity and improve quality of life. A definitive trial is now warranted.

KW - digital mobile Health (mHealth) intervention

KW - Just-in-Time Adaptive Intervention (JiTAIs)

KW - Ecological Momentary Assessment (EMA)

KW - clinical staging

KW - stress reactivity

KW - resilience

KW - stress reactivity/resilience

UR - https://www.scopus.com/pages/publications/85159543607

U2 - 10.1093/schbul/sbac212

DO - 10.1093/schbul/sbac212

M3 - Article

C2 - 36738168

SN - 0586-7614

VL - 49

SP - 592

EP - 604

JO - Schizophrenia Bulletin

JF - Schizophrenia Bulletin

IS - 3

ER -