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

NCT02270073 | Completed DMC

• 1 other identifier: MA6526/2-1(DFG)
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depression; Anxiety Disorder

Keywords

Psychotherapy process; Change mechanisms; Mindfulness; Micro-interventions; Mindfulness interventions; Progressive muscle relaxation

Outcome Measures

Primary Outcomes (2)

• Working Alliance Inventory - Short Revised (WAI-SR)

  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

  measured for 25 weeks on weekly basis, starting on first treatment day

• Brief Symptom Inventory (BSI)

  Self-report on general symptom severity of patients

  on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up

Secondary Outcomes (7)

• Beck Depression Inventory (BDI)

  on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up

• Inventory of Interpersonal Problems (IIP)

  on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up

• Kentucky Inventory of Mindfulness Skills (KIMS)

  on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up

• Global Assessment of Functioning (GAF)

  on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up

• Development of Psychotherapists Common Core Questionnaire (DPCCQ) short version

  on first treatment day, then on average: 15 weeks, and 12-months follow-up

Other Outcomes (3)

• Practice Quality-Mindfulness (PQ-M)

  on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up

• General Mindfulness Practice (GMP)

  on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks, and 12-months follow-up

• Therapist Presence Inventory (TPI)

  on average: after 5 weeks, 15 weeks, 25 weeks

Study Arms (3)

TAU + mindfulness intervention

EXPERIMENTAL

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

TAU + progressive muscle relaxation

ACTIVE COMPARATOR

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

Treatment as usual

OTHER

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

Interventions

Cognitive behavior therapy of trainee therapists BEHAVIORAL

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.

TAU + mindfulness intervention; TAU + progressive muscle relaxation; Treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• depressive disorder
• anxiety disorder
• treatment at the Center for Psychological Psychotherapy, University of Heidelberg

You may not qualify if:

• age below 18 or above 65
• insufficient German language skills
• psychotic disorder

Sponsors & Collaborators

• Heidelberg University: lead
• University of Trier: collaborator
• University of Zurich: collaborator
• University of Applied Sciences Esslingen: collaborator

Study Sites (1)

Center for Psychological Psychotherapy - University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69115, Germany

Location

Related Publications (4)

• Mander J, Kroger P, Heidenreich T, Fluckiger C, Lutz W, Bents H, Barnow S. The Process-Outcome Mindfulness Effects in Trainees (PrOMET) study: protocol of a pragmatic randomized controlled trial. BMC Psychol. 2015 Jul 17;3(1):25. doi: 10.1186/s40359-015-0082-3. eCollection 2015.

  PMID: 26185680 BACKGROUND

• Blanck P, Perleth S, Heidenreich T, Kroger P, Ditzen B, Bents H, Mander J. Effects of mindfulness exercises as stand-alone intervention on symptoms of anxiety and depression: Systematic review and meta-analysis. Behav Res Ther. 2018 Mar;102:25-35. doi: 10.1016/j.brat.2017.12.002. Epub 2017 Dec 20.

  PMID: 29291584 BACKGROUND

• Mander, J., Kröger, P., Blanck, P., Call, M., Bents, H., & Heidenreich, T. (2017). Theorie- Praxis-Netzwerke in verhaltenstherapeutischer Ausbildung: Schulung, Selbsterfahrung und Einsatz in der Therapie am Beispiel von Achtsamkeit [Theory- Practice Networks for Training in Behavioral Therapy: Training, Self-Discovery and Integration into Treatment Using Mindfulness as an Example]. Verhaltenstherapie, 27(2), 97-106.

  BACKGROUND

• Mander J, Blanck P, Neubauer AB, Kroger P, Fluckiger C, Lutz W, Barnow S, Bents H, Heidenreich T. Mindfulness and progressive muscle relaxation as standardized session-introduction in individual therapy: A randomized controlled trial. J Clin Psychol. 2019 Jan;75(1):21-45. doi: 10.1002/jclp.22695. Epub 2018 Oct 8.

  PMID: 30295914 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Johannes V Mander, PhD

  Center for Psychological Psychotherapy - University of Heidelberg

  PRINCIPAL INVESTIGATOR

• Hinrich Bents, PhD

  Center for Psychological Psychotherapy - University of Heidelberg

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 21, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 26, 2018

Record last verified: 2018-10

Locations

DE (1)