Mindfulness Interventions in Outpatient Cognitive Behavior Therapy in Trainee Therapists: The Process Outcome Mindfulness Effects in Trainees (PrOMET)-Study

Objectives.The main purpose of this study is to identify whether mindfulness exercises carried out at the beginning of individual therapy sessions help to improve the therapeutic process. More specifically, the investigators will examine the effects of a five minute in-session mindfulness intervention practiced by both outpatient and CBT trainee therapist at the beginning of 25 therapy sessions (duration: about 25 weeks) on the processes of therapeutic change measured with a session questionnaire completed after each of these 25 sessions (duration: about 25 weeks) and on clinical outcome assessed every 10 weeks starting at baseline under effectiveness conditions. Thus, before the start of therapeutic treatment, patients are randomized either to a treatment as usual + mindfulness intervention group (TAU+M), a control group practicing a short form of PMR (TAU+PMR), or a treatment as usual (TAU) group. Before the start of the intervention study, all therapists will participate in a six-week workshop-based mindfulness program. The investigators will examine the following hypotheses:

1. The investigators hypothesize that both patients and therapists of the TAU+M will experience higher levels of therapeutic alliance, as represented by the Working Alliance Inventory - Short Revised (WAI-SR), compared to the TAU+PMR and TAU.

2. The investigators hypothesize that in the TAU+M, there will be stronger reductions in clinical symptomatology of patients compared to the TAU+PMR and TAU.

3. There should be a stronger reduction in clinical symptomatology in the TAU+M versus the TAU+PMR and TAU after the first 25 sessions (duration: about 25 weeks), during which the mindfulness exercise is carried out.

4. This stronger reduction in clinical symptomatology should remain stable until follow-up.

Methods/Design. The study is a randomized controlled trial with three active treatment arms (TAU+M, TAU+PMR and TAU) under effectiveness conditions.It will be performed at the Center for Psychological Psychotherapy (CPP), a large university outpatient-training center for CBT at the University of Heidelberg. Approximately 1000 patients per year with different types of psychiatric disorders (about two-thirds suffering from anxiety and depression) are treated by approximately 100 trainee therapists there. Patients and therapists of the MIG perform together a brief, five-minute mindfulness exercise at the beginning of 25 therapy sessions (sessions performed on a weekly basis). Patients and therapists of the CG perform together a brief, five-minute version of progressive muscle relaxation at the beginning of 25 therapy sessions. In the TAU group, CPP standard psychotherapy procedure without interventions at the beginning of therapy sessions will be performed. Session-quality assessment will be performed after each of 25 therapy sessions from both patient and therapist perspective. Outcome assessment will be performed at baseline, every ten sessions during treatment, at the end of therapy, and at 12-months follow-up. A detailed description of the outcome measures is to be found under the "Primary and Secondary Outcome" sections.

Participants. A total of 30 trainee therapists and 150 patients will be recruited at the CPP. The general inclusion criterion for patients is a primary depressive or anxiety disorder diagnosis in the Structured Clinical Interview for the Diagnostic and Statistical Manual-IV (DSM-IV), German version. The investigators chose these two disorder groups as patients treated at German university therapy-training centers; approximately 40% suffer from a primary major depression as diagnosed, and approximately 30% suffer from a primary anxiety disorder as diagnosed. Hence, the investigators results will be of importance to a majority of outpatient diagnostic groups. General exclusion criteria for patients will be as follows: (1) an age below 18 or above 59 years, (2) insufficient German language skills, (3) suffering from a psychotic disorder. Other comorbidities are not considered as limitations to entering the study. Power analyses with G*Power and clinical considerations resulted in a sample size of 75 patients with depression and 75 patients with anxiety disorders.