TY - JOUR
T1 - Efficacy of a transdiagnostic ecological momentary intervention for improving self-esteem (SELFIE) in youth exposed to childhood adversity: study protocol for a multi-center randomized controlled trial
AU - Daemen, M.
AU - Postma, M.R.
AU - Lindauer, R.
AU - Hoes-van der Meulen, I.
AU - Nieman, D.
AU - Delespaul, P.
AU - Breedvelt, J.J.F.
AU - van der Gaag, M.
AU - Viechtbauer, W.
AU - Schruers, K.
AU - van den Berg, D.
AU - Bockting, C.
AU - van Amelsvoort, T.
AU - Reininghaus, U.
N1 - Funding Information:
This work was supported by a ZonMw mental health research program grant (dossier number 60-63600-98-346) and a DFG Heisenberg professorship (no. 389624707) to UR.
Funding Information:
We are indebted to all individuals, who participate in the SELFIE study and are essential for its successful completion. We thank all SELFIE therapists, who offer the SELFIE intervention, researchers (Nele Volbragt, Nele Soons, Fatima Ahouch, Sanne Visser, Josefien Breedvelt, Marieke van der Pluijm, Alisa Bogdanova), and interns. Further, we are grateful to all members of the TSC (Inez Germeys, Wolfgang Viechtbauer, and Johan Lataster) and DMEC (Philippe Delespaul, Karel Borkelmans, Marjan Drukker and Viviane Thewissen), Karel Borkelmans for implementing the SELFIE intervention and ESM in PsyMate, and all clinicians who referred their clients to us. Maastricht University is the primary sponsor of this study. The sponsor and funding agency do not have any role in the trial design, collection, analysis, or interpretation of data nor in writing the manuscript or in the decision to submit the report for publication.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/9/19
Y1 - 2021/9/19
N2 - Background: Targeting low self-esteem in youth exposed to childhood adversity is a promising strategy for preventing adult mental disorder, but psychological help remains difficult to access and accept for youth, calling for novel, youth-friendly approaches. Mobile Health (mHealth) and, most prominently, ecological momentary interventions (EMIs) provide a unique opportunity to deliver youth-friendly, personalized, real-time, guided self-help interventions. The aim of this study is to investigate the efficacy of a novel, accessible, transdiagnostic ecological momentary intervention for improving self-esteem ('SELFIE') in youth with prior exposure to childhood adversity.Methods/design: In a parallel-group, assessor-blind, multi-center randomized controlled trial, individuals aged 12-26 years with prior exposure to childhood adversity and low self-esteem will be randomly allocated to SELFIE in addition to treatment as usual (TAU) as the experimental condition or the control condition of TAU only, which will include access to all standard health care. SELFIE is a digital guided self-help intervention administered through a smartphone-based app to allow for interactive, personalized, real-time and real-world transfer of intervention components in individuals' daily lives, blended with three training sessions delivered by trained mental health professionals over a 6-week period. Outcomes will be assessed at baseline, post-intervention, and 6-month follow-up by blinded assessors. The primary outcome will be the level of self-esteem as measured with the Rosenberg Self-Esteem Scale (RSES).Discussion: The current study is the first to establish the efficacy of an EMI focusing on improving self-esteem transdiagnostically in youth exposed to childhood adversity. If this trial provides evidence on the efficacy of SELFIE, it has significant potential to contribute to minimizing the deleterious impact of childhood adversity and, thereby, preventing the development of mental disorder later in life.
AB - Background: Targeting low self-esteem in youth exposed to childhood adversity is a promising strategy for preventing adult mental disorder, but psychological help remains difficult to access and accept for youth, calling for novel, youth-friendly approaches. Mobile Health (mHealth) and, most prominently, ecological momentary interventions (EMIs) provide a unique opportunity to deliver youth-friendly, personalized, real-time, guided self-help interventions. The aim of this study is to investigate the efficacy of a novel, accessible, transdiagnostic ecological momentary intervention for improving self-esteem ('SELFIE') in youth with prior exposure to childhood adversity.Methods/design: In a parallel-group, assessor-blind, multi-center randomized controlled trial, individuals aged 12-26 years with prior exposure to childhood adversity and low self-esteem will be randomly allocated to SELFIE in addition to treatment as usual (TAU) as the experimental condition or the control condition of TAU only, which will include access to all standard health care. SELFIE is a digital guided self-help intervention administered through a smartphone-based app to allow for interactive, personalized, real-time and real-world transfer of intervention components in individuals' daily lives, blended with three training sessions delivered by trained mental health professionals over a 6-week period. Outcomes will be assessed at baseline, post-intervention, and 6-month follow-up by blinded assessors. The primary outcome will be the level of self-esteem as measured with the Rosenberg Self-Esteem Scale (RSES).Discussion: The current study is the first to establish the efficacy of an EMI focusing on improving self-esteem transdiagnostically in youth exposed to childhood adversity. If this trial provides evidence on the efficacy of SELFIE, it has significant potential to contribute to minimizing the deleterious impact of childhood adversity and, thereby, preventing the development of mental disorder later in life.
KW - SELFIE
KW - Ecological momentary intervention
KW - mHealth
KW - Experience Sampling Method
KW - Self-esteem
KW - Childhood trauma
KW - Childhood adversity
KW - MENTAL-HEALTH-SERVICES
KW - ULTRA-HIGH RISK
KW - AGE-OF-ONSET
KW - SEXUAL-ABUSE
KW - PSYCHIATRIC-DISORDERS
KW - PSYCHOMETRIC PROPERTIES
KW - HIERARCHICAL TAXONOMY
KW - PSYCHOPATHOLOGY HITOP
KW - TRAUMA QUESTIONNAIRE
KW - GLOBAL BURDEN
U2 - 10.1186/s13063-021-05585-y
DO - 10.1186/s13063-021-05585-y
M3 - Article
C2 - 34538272
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 641
ER -