The Process Outcome Mindfulness Effects in Trainees (PrOMET)-Study
Information source: Heidelberg University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression; Anxiety Disorder
Intervention: Cognitive behavior therapy of trainee therapists (Behavioral)
Phase: N/A
Status: Recruiting
Sponsored by: Heidelberg University Official(s) and/or principal investigator(s): Johannes V Mander, PhD, Principal Investigator, Affiliation: Center for Psychological Psychotherapy - University of Heidelberg Hinrich Bents, PhD, Study Director, Affiliation: Center for Psychological Psychotherapy - University of Heidelberg Sven Barnow, PhD, Study Chair, Affiliation: Department of Clinical Psychology and Psychotherapy - University of Heidelberg Christoph Flueckiger, PhD, Study Chair, Affiliation: Department of Clinical Psychology and Psychotherapy - University of Zuerich Thomas Heidenreich, PhD, Study Chair, Affiliation: Faculty of Social Work, Health and Nursing - University of Applied Sciences Esslingen Wolfgang Lutz, PhD, Study Chair, Affiliation: Department of Clinical Psychology and Psychotherapy - University of Trier
Overall contact: Johannes V Mander, PhD, Phone: 00496221547902, Email: johannes.mander@zpp.uni-hd.de
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.
Clinical Details
Official title: Mindfulness Interventions in Outpatient Cognitive Behavior Therapy in Trainee Therapists: The Process Outcome Mindfulness Effects in Trainees (PrOMET)-Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Working Alliance Inventory - Short Revised (WAI-SR)Brief Symptom Inventory (BSI)
Secondary outcome: Beck Depression Inventory (BDI)Inventory of Interpersonal Problems (IIP) Kentucky Inventory of Mindfulness Skills (KIMS) Global Assessment of Functioning (GAF) Development of Psychotherapists Common Core Questionnaire (DPCCQ) short version Scale for the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (SACiP) Beck Anxiety Inventory (BAI)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- depressive disorder
- anxiety disorder
- treatment at the Center for Psychological Psychotherapy, University of Heidelberg
Exclusion Criteria:
- age below 18 or above 65
- insufficient German language skills
- psychotic disorder
Locations and Contacts
Johannes V Mander, PhD, Phone: 00496221547902, Email: johannes.mander@zpp.uni-hd.de
Center for Psychological Psychotherapy - University of Heidelberg, Heidelberg, Baden Wuerttemberg 69115, Germany; Recruiting Johannes V Mander, PhD, Phone: 00496223547902, Email: johannes.mander@zpp.uni-hd.de
Additional Information
Starting date: October 2014
Last updated: June 17, 2015
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