Game-Based Meditation Therapy to Improve Posttraumatic Stress and Neurobiological Stress Systems in Traumatized Adolescents: Protocol for a Randomized Controlled Trial

Abstract

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 relaxation abilities. 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 resting parameters. 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 International Registered Report Identifier (IRRID) DERR1-10.2196/19881

Alterations of autonomic nervous system and HPA axis basal activity and reactivity to acute stress: a comparison of traumatized adolescents and healthy controls

“…This study was part of a project that included two studies: the current comparison study and a RCT (Schuurmans et al, 2020). Both studies were evaluated by the medical ethical committee Arnhem-Nijmegen which provided ethical review and approval under protocol NL58674.091.16.…”

“…Participants had 30 s to choose a song and had to sing the song aloud for 30 s. At the end of the testing session, participants received a gift voucher of e15. For detailed information on the measurement procedures, see Schuurmans et al (2020).…”

“…These participants (N ¼ 77) were recruited in residential youth care institutions in the Netherlands. For detailed information on this study see Schuurmans et al (2020).…”

“…An a priori power analysis for repeated measures ANOVA with a small-to-medium effect size of d ¼ .30 estimated a sample size of 72 with 36 participants in each condition (Schuurmans et al, 2020). In total, 77 clinical participants were recruited for the RCT and used as a convenience sample for the current study.…”

Role of meditation to improve children's health: Time to look at other strategies

“…There are currently a number of protocols available for studies that are in the process of investigating meditation and mindfulness in specific populations of children and adolescents, including those with post‐traumatic stress disorder, 35 ADHD, 36 polycystic ovary syndrome, 37 inflammatory bowel disease 38 and other chronic health conditions 39 . These studies may be promising additions to the current body of evidence and will continue to provide a basis for implementing meditation and mindfulness in medical practice for those with the health conditions described.…”