The Process Outcome Mindfulness Effects in Trainees (PrOMET)-Study
Condition: Major Depression; Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      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-judgemental,
      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. Consequently, the demand to investigate mindfulness under effectiveness conditions
      in trainee therapists has been highlighted.

      Methods/Design: To fill in this research gap, the investigators designed the PrOMET-Study. In
      this study, the investigators will analyze the effects of brief, audio-tape presented,
      in-session mindfulness interventions conducted by both trainee therapists and their patients
      at the beginning of individual therapy sessions in a randomized, controlled longitudinal
      design under effectiveness conditions in a total of 30 trainee therapists and 150 patients in
      a large outpatient training center. The investigators hypothesize the mindfulness
      intervention will have positive effects on therapeutic processes and outcome in contrast to a
      progressive muscle relaxation and a treatment as usual group. The investigators will conduct
      multilevel modeling to address the nested data structure.

      Discussion: The study results could provide important practical implications, as they could
      inform ideas on how to improve clinical training of psychotherapists that could be
      implemented very, as there is no need for complex infrastructures or additional time
      concerning these brief, in-session mindfulness interventions that are directly implemented in
      treatment sessions.
    

Detailed description: 
      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.

             1. 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.

             2. 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.

      Randomization. A total sample of 150 patients will be assigned to one of the three groups by
      a stratified randomization process. The randomization process will be performed after a five
      session diagnostic stage. Patients will be stratified into one of two categories: one group
      with the main diagnosis of major depression and the other group with the main diagnosis of
      anxiety disorder. Then, an online randomization will be performed by two independent research
      assistants.

      Mindfulness workshop training. In order to prepare the 30 trainee therapists for the
      in-session mindfulness interventions outlined in the next section, the investigators will
      first offer two workshops separated by a six-week home-practice interval to all trainee
      therapists participating in the study. The workshops will be offered once every year when a
      new group of trainee therapists starts their outpatient therapies. The first workshop will
      provide a theoretical background in mindfulness. In the six-week interval between workshops
      one and two, participants will practice formal and informal mindfulness activities at home.
      In the second workshop, specifically addressing the mindfulness experiences of participants
      and suggestions for further improvements will be the focus.

      Experimental Session.The experiment will be conducted at the university training center CPP.
      During the five-minute mindfulness experimental task, both patient and therapist of the TAU+M
      sit at a distance about one meter from the audio recorder. After the initial greeting ritual,
      both patient and therapist perform together the brief mindfulness intervention for the first
      five minutes of the therapy session. While performing the exercise, patient and therapist sit
      upright in their chairs in a comfortable position, with their feet flat on the floor, arms
      and legs uncrossed, and hands resting in their laps. The mindfulness text is standardized and
      spoken by Dr. Thomas Heidenreich, an internationally renowned expert on mindfulness research.
      During the exercise, participants are instructed to observe their body sensations, followed
      by non-judgemental and purposeful acknowledgements of personal problems and resources of the
      patient. After completion of the mindfulness intervention, the regular therapy session
      begins. Following the treatment session, both patient and therapist complete the session
      questionnaire described under "Primary and Secondary Outcomes", which requires about two
      minutes. The TAU+PMR also receives a five-minute audiotaped exercise under basically the same
      conditions; more specifically, they will receive a short version of PMR that is also spoken
      by Dr. Heidenreich. On the one hand, PMR is a broadly accepted and easy to implement
      relaxation exercise that is applied most often as a control intervention when investigating
      mindfulness interventions. On the other hand, it does not include the hypothesized specific
      effective ingredients of the mindfulness intervention (mindful observation of physiological
      and psychological conditions). The wording of the control intervention is as similar to the
      experimental mindfulness intervention as possible. The TAU will conduct standard individual
      therapy sessions as usual at the CPP.

      Recruitment of patients and therapists. Standard procedure at the CPP is that patients are
      listed on a waiting list after a diagnostic screening phone call. After patients are listed
      on the waiting list, they will be contacted by the study team and receive verbal and written
      information on the study. At the beginning of every year, a group of trainee therapists at
      the CPP starts their outpatient therapies. Consequently, trainees receive at the beginning of
      every year verbal and written information on the study. Trainees who participate in the study
      will then participate in the two mindfulness workshops described above that are offered at
      the beginning of every year. The information given to the participants of the study includes
      a precise description of inclusion and exclusion criteria, information concerning the
      interventions and questionnaires as well as the data collection procedure. Further, it will
      be emphasized that study participation is on a voluntary basis and that there is the option
      to revoke consent to participate in the study at any time without having to cite reasons or
      suffering disadvantages. Moreover, participants have the opportunity to instruct the study
      team to delete their data without providing reasons.

      Development and feasibility of the intervention. The mindfulness exercise was developed in an
      iterative process in multiple steps: First, Dr. Heidenreich and Dr. Mander phrased a
      preliminary version based on the breathing space exercise by Michalak, Heidenreich and
      Williams and on the mindfulness centering exercise by Eifert and Forsyth. Further, 10
      therapists and 10 patients conducted this preliminary exercise in one therapy session and
      delivered feedback. After improving the exercise according to these patient and therapist
      feedbacks, five mindfulness experts and two experts in psychotherapy process research
      reviewed the exercise and offered feedbacks for improvement. Based on these feedback
      processes, the final version of the mindfulness intervention was developed.The feasibility of
      the brief in-session mindfulness intervention and of the PMR intervention was tested in a
      pre-study with 12 therapists and 12 patients. Both patients and therapists conducted the
      exercise at the beginning of one therapy session at the CPP and completed the session
      questionnaire after the therapy session. Additionally, they completed questions on a scale
      from 0 (does not apply) to 4 (applies fully) concerning the feasibility of the interventions.
      The results indicated that the interventions could be integrated without problems in the
      everyday therapeutic process, that the instructions were understandable and that the
      exercises generally had a positive impact on the therapy sessions.

      Statistical Analysis. The investigators will apply a multilevel modeling approach to address
      the nested data structure (sessions at level 1 nested within patients at level 2 nested
      within therapists at level 3): Thereby, the investigators will treat time as a within-subject
      factor and treatment condition as a between-subject factor. The investigators will analyze
      main effects, that is, differences in intercepts of TAU+M versus TAU+PMR versus TAU
      concerning process and outcome variables, and interactive effects, that is, differences in
      slopes of TAU+M versus TAU+PMR versus TAU concerning process and outcome variables. The
      investigators statistical hypothesis implies that the intercept is significantly higher in
      the TAU+M than in the TAU+PMR and the TAU concerning both process and outcome variables.
      Additionally, it implies that the slope increases significantly stronger in the TAU+M than in
      the TAU+PMR and the TAU concerning both process and outcome variables. The investigators will
      conduct analyses on the intention-to-treat sample as well as on the completer sample.
      Further, patients and therapists pre-treatment characteristics will be investigated as
      outcome predictors at levels 2 and 3 to control for differential effects on outcome in the
      three treatment arms.
    

Intervention name(s): Cognitive behavior therapy of trainee therapists
Intervention type(s): Behavioral
Intervention description(s): In all three treatment arms, trainee therapists perform a cognitive behavior therapy (CBT) under conditions of the German health care system. This treatment is not a manualized intervention, but rather based on individualized treatment plans that have been developed together with expert supervisors during a five session diagnostic stage. Treatment duration is 25 sessions, while on average every fourth is supervized by an CBT expert therapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychotherapy process; Change mechanisms; Mindfulness; Micro-interventions; Mindfulness interventions; Progressive muscle relaxation