Major Depression Clinical Trial
— PrOMETOfficial title:
Mindfulness Interventions in Outpatient Cognitive Behavior Therapy in Trainee Therapists: The Process Outcome Mindfulness Effects in Trainees (PrOMET)-Study
NCT number | NCT02270073 |
Other study ID # | MA6526/2-1(DFG) |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | July 2018 |
Verified date | October 2018 |
Source | Heidelberg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | July 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Center for Psychological Psychotherapy - University of Heidelberg | Heidelberg | Baden Wuerttemberg |
Lead Sponsor | Collaborator |
---|---|
Heidelberg University | University of Applied Sciences Esslingen, University of Trier, University of Zurich |
Germany,
Blanck P, Perleth S, Heidenreich T, Kröger 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. — View Citation
Mander J, Blanck P, Neubauer AB, Kröger P, Flückiger 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. 2018 — View Citation
Mander J, Kröger P, Heidenreich T, Flückiger 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. — View Citation
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Practice Quality-Mindfulness (PQ-M) | Measures presence of therapists and patients during the interventions at beginning of therapy sessions | on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up | |
Other | General Mindfulness Practice (GMP) | Instrument to assess therapists personal mindfulness practice, experience before entering study and intensity of mindfulness application in therapy sessions | on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks, and 12-months follow-up | |
Other | Therapist Presence Inventory (TPI) | Instrument to assess general session presence | on average: after 5 weeks, 15 weeks, 25 weeks | |
Primary | 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 | |
Primary | 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 | Beck Depression Inventory (BDI) | Self-report on depressive symptoms of patients | on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up | |
Secondary | Inventory of Interpersonal Problems (IIP) | Self-report on interpersonal problems of patients | on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up | |
Secondary | Kentucky Inventory of Mindfulness Skills (KIMS) | Self-report on patients and therapists mindfulness abilities | on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up | |
Secondary | Global Assessment of Functioning (GAF) | Therapist perspective on patient´s general symptomatology | on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up | |
Secondary | Development of Psychotherapists Common Core Questionnaire (DPCCQ) short version | Self-report on therapists-variables from therapist perspective | on first treatment day, then on average: 15 weeks, and 12-months follow-up | |
Secondary | Scale for the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (SACiP) | Instrument to assess general therapeutic change mechanisms | on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up | |
Secondary | Beck Anxiety Inventory (BAI) | Self-report on anxiety symptoms of patients | on first treatment day, then on average: after 5 weeks, 15 weeks, 25 weeks and 12-months follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03062150 -
Mineralocorticoid Receptor, NMDA Receptor and Cognitive Function in Depression
|
N/A | |
Completed |
NCT04352101 -
Bupropion Versus Escitalopram on Reward Circuitry and Motivational Deficits
|
Phase 4 | |
Completed |
NCT02855918 -
Blood Biomarkers in Suicidal Behaviour
|
N/A | |
Recruiting |
NCT03039387 -
Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients
|
N/A | |
Recruiting |
NCT02213016 -
Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients
|
Phase 4 | |
Completed |
NCT01683539 -
Understanding How Cognitive Remediation Works
|
N/A | |
Completed |
NCT01636791 -
CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care
|
Phase 3 | |
Recruiting |
NCT02237937 -
Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene
|
Phase 4 | |
Completed |
NCT01201148 -
Open Pilot Trial of TES for Depression
|
Phase 2 | |
Completed |
NCT00953108 -
Quetiapine Prolong, Escitalopram and Hypothalamic-pituitary-adrenocortical (HPA) Axis Activity in Depressed Patients
|
Phase 3 | |
Terminated |
NCT00695552 -
The Effect of Exercise on Depressive Symptoms in Unmedicated Patients
|
N/A | |
Terminated |
NCT01244711 -
Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines
|
Phase 4 | |
Completed |
NCT00711737 -
Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months
|
N/A | |
Completed |
NCT00806143 -
Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression
|
Phase 4 | |
Completed |
NCT00466323 -
The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness.
|
N/A | |
Completed |
NCT00532480 -
Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine
|
Phase 4 | |
Completed |
NCT00482482 -
Yoga in Unipolar and Bipolar Disorders
|
N/A | |
Completed |
NCT00616759 -
The Effect on Cognition of Terminating ECT Induced Seizures With Propofol
|
N/A | |
Recruiting |
NCT00209807 -
Effect of Escitalopram vs. Reboxetine on Gastro-intestinal Sensitivity of Patients With Major Depressive Disorder
|
Phase 4 | |
Completed |
NCT00149110 -
Chronos: the Use of Chronobiological Treatment in Depression
|
N/A |