The Process Outcome Mindfulness Effects in Trainees (PrOMET)-Study (PrOMET)
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ClinicalTrials.gov Identifier: NCT02270073 |
Recruitment Status :
Completed
First Posted : October 21, 2014
Last Update Posted : October 26, 2018
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Major Depression Anxiety Disorder | Behavioral: Cognitive behavior therapy of trainee therapists | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
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 |
Actual Study Start Date : | October 2014 |
Actual Primary Completion Date : | January 2018 |
Actual Study Completion Date : | July 2018 |
Arm | Intervention/treatment |
---|---|
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. |
- 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
- 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
- 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
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Germany | |
Center for Psychological Psychotherapy - University of Heidelberg | |
Heidelberg, Baden Wuerttemberg, Germany, 69115 |
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 |
Other Publications:
Responsible Party: | Johannes Mander, Dr, Heidelberg University |
ClinicalTrials.gov Identifier: | NCT02270073 |
Other Study ID Numbers: |
MA6526/2-1(DFG) |
First Posted: | October 21, 2014 Key Record Dates |
Last Update Posted: | October 26, 2018 |
Last Verified: | October 2018 |
Psychotherapy process Change mechanisms Mindfulness |
Micro-interventions Mindfulness interventions Progressive muscle relaxation |
Anxiety Disorders Mental Disorders |