- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02415426
Metacognitive Training Program With Depression (DMKT)
November 20, 2017 updated by: Prof. Dr. med. Egemen Savaskan, Psychiatric University Hospital, Zurich
The participants of this study have been diagnosed with mild to moderate depression with no evidence of suicidal actions prior to recruitment.
All recruited subjects receive standard therapy and participate in a metacognitive training program (D-MKT) independently of study participation.
Diagnostic and therapeutical interventions are not part of this study.
As part of this study, the change of cognitive and psychosocial achievement/behavior in patients with mild to moderate depression after taking part in the training program is being investigated.
The training program seeks to enable group members to recognize and correct the often automatic and unconscious thought patterns that accompany depression, in part by viewing this depressive thought process at a distance (i.e., depersonalizing).
In addition, dysfunctional assumptions about one's thought processes, as well as dysfunctional coping-strategies (i.e., thought suppression, rumination as problem-solving) are targeted (Lena Jelinek & Steffen Moritz, http://clinical-neuropsychology.de/metacognitive_training_for_depression.html).
Within this study the cognitive and psychosocial behaviour changes are being investigated by neuropsychological assessment as well as questionnaires.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zürich, Switzerland, 8032
- Klinik für Alterspsychiatrie, Gerontopsychiatrisches Zentrum Hegibach
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients from our ambulatorium
Description
Inclusion Criteria:
- Participation in the Metacognitive Training Program
- Subjects with an age over 55 years and a diagnosed mild to moderate depression without psychotic Symptoms (F32, F33)
- Subjects have to be able to understand verbal and written information regarding treatment and procedures of the study.
- Subjects have to be able to understand and perform verbal and written tasks (cognitive tests/questionnaires).
- No evidence of suicidal tendency
Exclusion Criteria:
- Taking of medication or drugs that could influence cognition
- Diseases that prevent the subject from giving consent to this study or affect the collaboration during the examination
- Major and/or unstable physical diseases
- Strongly impaired vision/eye diseases
- Psychotic or manic symptoms
- Benzodiazepine addiction/dependency
- Suicidal tendency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement of depression as measured by Becks Depression Inventory (BDI)
Time Frame: 14 months
|
14 months
|
Improvement of depression as measured by Hamilton Depression Scale (HAMD)
Time Frame: 14 months
|
14 months
|
Improvement of self-esteem as measured by Rosenberg Self-esteem Scale (RSE)
Time Frame: 14 months
|
14 months
|
Improvement of dysfunctional coping strategies as measured by 10-Item-Version of the Response Styles Questionnaire in German (RSQ-D)
Time Frame: 14 months
|
14 months
|
Improvement of dysfunctional coping strategies as measured by Dysfunctional Attitude Scale (DAS)
Time Frame: 14 months
|
14 months
|
Improvement of satisfaction and subjective well-being as measured by World Health Organization Quality of Life - short version (WHOQOL-BREF)
Time Frame: 14 months
|
14 months
|
Improvement of metacognitive thinking as measured by Metacognitions Questionnaire (MCQ)
Time Frame: 14 months
|
14 months
|
Improvement of cognition as measured by Consortium to Establish a Registry for Alzheimer's Disease (CERAD-Plus)
Time Frame: 14 months
|
14 months
|
Improvement of cognition as measured by 5-Point Test
Time Frame: 14 months
|
14 months
|
Improvement of cognition as measured by Regensburger Wortflüssigkeitstest (RWT)
Time Frame: 14 months
|
14 months
|
Improvement of cognition as measured by Tower of London
Time Frame: 14 months
|
14 months
|
Improvement of cognition as measured by Wechsler Memory Scale Revised (WMS-R)
Time Frame: 14 months
|
14 months
|
Improvement of cognition as measured by Trail Making Test (TMT)
Time Frame: 14 months
|
14 months
|
Improvement of cognition as measured by Wechsler Adult Intelligence Scale (WAIS-IV)
Time Frame: 14 months
|
14 months
|
Improvement of cognition as measured by Verbaler Lern- und Merkfähigkeitstest (VLMT)
Time Frame: 14 months
|
14 months
|
Improvement of cognition as measured by Testbatterie zur Aufmerksamkeitsprüfung (TAP)
Time Frame: 14 months
|
14 months
|
Improvement of cognition as measured by MWT
Time Frame: 14 months
|
14 months
|
Improvement of cognition as measured by Cartoon Test
Time Frame: 14 months
|
14 months
|
Improvement of cognition as measured by Faux Pas Test
Time Frame: 14 months
|
14 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
March 26, 2015
First Submitted That Met QC Criteria
April 8, 2015
First Posted (Estimate)
April 14, 2015
Study Record Updates
Last Update Posted (Actual)
November 21, 2017
Last Update Submitted That Met QC Criteria
November 20, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D-MKT - 2014-0421
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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