title: The Process-Outcome Mindfulness Effects in Trainees (PrOMET) study: protocol of a pragmatic randomized controlled trial.
abstract: BACKGROUND
  Mindfulness has its origins in an Eastern Buddhist tradition that is over 2500 years old and can be defined as a specific form of attention that is non-judgmental, purposeful, and focused on the present moment. It has been well established in cognitive-behavior therapy in the last decades, while it has been investigated in manualized group settings such as mindfulness-based stress reduction and mindfulness-based cognitive therapy. However, there is scarce research evidence on the effects of mindfulness as a treatment element in individual therapy. Consequently, the demand to investigate mindfulness under effectiveness conditions in trainee therapists has been highlighted.
  
  
  METHODS
  To fill in this research gap, we designed the PrOMET Study. In our study, we will investigate the effects of brief, audiotape-presented, session-introducing interventions with mindfulness elements conducted by trainee therapists and their patients at the beginning of individual therapy sessions in a prospective, randomized, controlled design under naturalistic conditions with a total of 30 trainee therapists and 150 patients with depression and anxiety disorders in a large outpatient training center. We hypothesize that the primary outcomes of the session-introducing intervention with mindfulness elements will be positive effects on therapeutic alliance (Working Alliance Inventory) and general clinical symptomatology (Brief Symptom Checklist) in contrast to the session-introducing progressive muscle relaxation and treatment-as-usual control conditions. Treatment duration is 25 therapy sessions. Therapeutic alliance will be assessed on a session-to-session basis. Clinical symptomatology will be assessed at baseline, session 5, 15 and 25. We will conduct multilevel modeling to address the nested data structure. The secondary outcome measures include depression, anxiety, interpersonal functioning, mindful awareness, and mindfulness during the sessions.
  
  
  CONCLUSIONS
  The study results could provide important practical implications because they could inform ideas on how to improve the clinical training of psychotherapists that could be implemented very easily; this is because there is no need for complex infrastructures or additional time concerning these brief session-introducing interventions with mindfulness elements that are directly implemented in the treatment sessions.
  
  
  BACKGROUND
  From ClinicalTrials.gov, Identifier: NCT02270073 (registered October 6, 2014).
authors.affiliation: University of Heidelberg, Center for Psychological Psychotherapy, Bergheimer Str. 58a, 69115 Heidelberg, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Mander
authors.affiliation: University of Heidelberg, Center for Psychological Psychotherapy, Bergheimer Str. 58a, 69115 Heidelberg, Germany.
authors.forename: Paula
authors.initials: P
authors.lastname: Kröger
authors.affiliation: Department of Social Work, Health and Nursing, University of Applied Sciences Esslingen, Esslingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Heidenreich
authors.affiliation: Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Flückiger
authors.affiliation: Department of Clinical Psychology and Psychotherapy, University of Trier, Trier, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Lutz
authors.affiliation: University of Heidelberg, Center for Psychological Psychotherapy, Bergheimer Str. 58a, 69115 Heidelberg, Germany.
authors.forename: Hinrich
authors.initials: H
authors.lastname: Bents
authors.affiliation: Department of Clinical Psychology and Psychotherapy, University of Heidelberg, Heidelberg, Germany.
authors.forename: Sven
authors.initials: S
authors.lastname: Barnow
keywords: Mindfulness; Multilevel models; Psychotherapy; Randomized controlled trial; Therapeutic alliance