We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Process Outcome Mindfulness Effects in Trainees (PrOMET)-Study (PrOMET)

This study is currently recruiting participants.
Verified October 2016 by Heidelberg University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02270073
First Posted: October 21, 2014
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Trier
University of Zurich
University of Applied Sciences Esslingen
Information provided by (Responsible Party):
Heidelberg University
  Purpose

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.


Condition Intervention
Major Depression Anxiety Disorder Behavioral: Cognitive behavior therapy of trainee therapists

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness Interventions in Outpatient Cognitive Behavior Therapy in Trainee Therapists: The Process Outcome Mindfulness Effects in Trainees (PrOMET)-Study

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Working Alliance Inventory - Short Revised (WAI-SR) [ Time Frame: measured for 25 weeks on weekly basis, starting on first treatment day ]
    The WAI-SR is a self-report of therapeutic alliance measuring Bond, Goals and Tasks in psychotherapy based on feedback of both patients and therapists concerning the current therapy session

  • Brief Symptom Inventory (BSI) [ Time Frame: on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up ]
    Self-report on general symptom severity of patients


Secondary Outcome Measures:
  • Beck Depression Inventory (BDI) [ Time Frame: on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up ]
    Self-report on depressive symptoms of patients

  • Inventory of Interpersonal Problems (IIP) [ Time Frame: on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up ]
    Self-report on interpersonal problems of patients

  • Kentucky Inventory of Mindfulness Skills (KIMS) [ Time Frame: on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up ]
    Self-report on patients and therapists mindfulness abilities

  • Global Assessment of Functioning (GAF) [ Time Frame: on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up ]
    Therapist perspective on patient´s general symptomatology

  • Development of Psychotherapists Common Core Questionnaire (DPCCQ) short version [ Time Frame: on first treatment day, then on average: 15 weeks, and 12-months follow-up ]
    Self-report on therapists-variables from therapist perspective

  • Scale for the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (SACiP) [ Time Frame: on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up ]
    Instrument to assess general therapeutic change mechanisms

  • Beck Anxiety Inventory (BAI) [ Time Frame: on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up ]
    Self-report on anxiety symptoms of patients


Other Outcome Measures:
  • Practice Quality-Mindfulness (PQ-M) [ Time Frame: on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up ]
    Measures presence of therapists and patients during the interventions at beginning of therapy sessions

  • General Mindfulness Practice (GMP) [ Time Frame: on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks, and 12-months follow-up ]
    Instrument to assess therapists personal mindfulness practice, experience before entering study and intensity of mindfulness application in therapy sessions

  • Therapist Presence Inventory (TPI) [ Time Frame: on average: after 5 weeks, 15 weeks, 25 weeks ]
    Instrument to assess general session presence


Estimated Enrollment: 150
Study Start Date: October 2014
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAU + mindfulness intervention

In the first five minutes of each of 25 therapy sessions (duration: about 25 weeks), both patient and therapist perform together the brief intervention with mindfulness elements. Participants sit upright in their chairs in a comfortable position at a distance about one meter from the audio recorder. The text is standardized and spoken by Dr. Thomas Heidenreich. During the exercise, participants are instructed to observe their breathing and body sensations. After completion of the mindfulness intervention, the regular therapy session begins.

Intervention: Cognitive behavior therapy of trainee therapists

Behavioral: Cognitive behavior therapy of trainee therapists
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.
Active Comparator: TAU + progressive muscle relaxation

In the first five minutes of each of 25 therapy sessions (duration: about 25 weeks), both patient and therapist perform together a short version of progressive muscle relaxation (PMR). Both patient and therapist sit upright in their chairs in a comfortable position at a distance about one meter from the audio recorder. The PMR text is standardized and spoken by Dr. Thomas Heidenreich. Wording is as similar as possible to the mindfulness interventions.During the exercise, participants are instructed to tense and relax arms, face, body and legs. After completion of PMR, the regular therapy session begins.

Intervention: Cognitive behavior therapy of trainee therapists

Behavioral: Cognitive behavior therapy of trainee therapists
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.
Treatment as usual

No specific intervention is conducted at the beginning of therapy sessions. Standard cognitive behavior therapy treatment, based on the individualized case conception of the trainee therapist, is conducted during the whole treatment sessions.

Intervention: Cognitive behavior therapy of trainee therapists

Behavioral: Cognitive behavior therapy of trainee therapists
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270073


Contacts
Contact: Johannes V Mander, PhD 00496221547902 johannes.mander@zpp.uni-hd.de

Locations
Germany
Center for Psychological Psychotherapy - University of Heidelberg Recruiting
Heidelberg, Baden Wuerttemberg, Germany, 69115
Contact: Johannes V Mander, PhD    00496223547902    johannes.mander@zpp.uni-hd.de   
Sponsors and Collaborators
Heidelberg University
University of Trier
University of Zurich
University of Applied Sciences Esslingen
Investigators
Principal Investigator: Johannes V Mander, PhD Center for Psychological Psychotherapy - University of Heidelberg
Study Director: Hinrich Bents, PhD Center for Psychological Psychotherapy - University of Heidelberg
Study Chair: Sven Barnow, PhD Department of Clinical Psychology and Psychotherapy - University of Heidelberg
Study Chair: Christoph Flueckiger, PhD Department of Clinical Psychology and Psychotherapy - University of Zuerich
Study Chair: Thomas Heidenreich, PhD Faculty of Social Work, Health and Nursing - University of Applied Sciences Esslingen
Study Chair: Wolfgang Lutz, PhD Department of Clinical Psychology and Psychotherapy - University of Trier
  More Information

Publications:
Responsible Party: Heidelberg University
ClinicalTrials.gov Identifier: NCT02270073     History of Changes
Other Study ID Numbers: MA6526/2-1(DFG)
First Submitted: October 6, 2014
First Posted: October 21, 2014
Last Update Posted: October 27, 2016
Last Verified: October 2016

Keywords provided by Heidelberg University:
Psychotherapy process
Change mechanisms
Mindfulness
Micro-interventions
Mindfulness interventions
Progressive muscle relaxation

Additional relevant MeSH terms:
Anxiety Disorders
Depressive Disorder, Major
Mental Disorders
Depressive Disorder
Mood Disorders