||Background: Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence,
neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral
outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular
on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations.
An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse
is a game-based meditation intervention that makes use of adolescents’intrinsic motivation. The neurofeedback element reinforces
Objective: This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness
of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized
adolescents in residential care.
Methods: This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be
adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either
the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3
measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms
(self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters
under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also
include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological
Results: The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The
study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected
to be published in spring or summer 2021.
Conclusions: Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and
neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents.
Trial Registration: Netherlands Trial Register NL6689 (NTR6859); https://www.trialregister.nl/trial/6689