The impact of session-introducing mindfulness and relaxation interventions in individual psychotherapy for children and adolescents: a randomized controlled trial (MARS-CA).

backgroundThe investigation of mindfulness-based interventions (MBIs) in cognitive-behavioral therapy has greatly increased over the past years. However, most MBI research with youth focuses on structured, manualized group programs, conducted in school settings. Knowledge about the implementation and effects of MBIs in individual psychotherapy with children and adolescents is scarce. To fill this research gap, the "Mindfulness and Relaxation Study - Children and Adolescents" (MARS-CA) is designed. It aims to assess the effects of short session-introducing interventions with mindfulness elements on juvenile patients' symptomatic outcome and therapeutic alliance in individual child and adolescent psychotherapy.

methodsMARS-CA is conducted at a university outpatient training center for cognitive-behavior therapy. Short session-introducing interventions with mindfulness elements will be compared to short session-introducing relaxation interventions and no session-introducing intervention to explore their effects on symptomatic outcome and therapeutic alliance. The session-introducing interventions will take place at the beginning of 24 subsequent therapy sessions. We hypothesize that patients' symptomatic outcome and therapeutic alliance improve more strongly in the mindfulness condition than in the other two conditions and that the mindfulness condition moderates the relationship between therapeutic alliance and symptomatic outcome. Patients and their trainee therapists will be randomized to one of the three treatment arms. Participants aged between 11 and 19 years and having a primary diagnosis of either a depressive disorder, an anxiety disorder, or a hyperkinetic disorder will be included. Therapeutic alliance will be assessed after every therapy session (therapy session 1 to therapy session 24), symptomatic outcome will be assessed before the start of treatment (pre), after the 3rd, the 10th, and the 17th therapy sessions, at the end of treatment (24th therapy session, post), and at a 6-month follow-up. Additionally, mindfulness and mindfulness-related measures as well as demographic data, adherence, allegiance, and therapeutic techniques will be assessed. It is our aim to assess a sample of 135 patients. We will conduct multilevel modeling to address the nested data structure. DISCUSSION: The study can provide information about how add-on MBIs, conducted by trainee therapists, influence therapeutic alliance and symptomatic outcome in individual psychotherapy in children and adolescents.

trial registrationClinicalTrials.gov NCT04034576. Registered on July 17, 2019.