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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Switzerland
      • Zürich, Switzerland, 8032
        • Klinik für Alterspsychiatrie, Gerontopsychiatrisches Zentrum Hegibach

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Psychiatric University Hospital, Zurich

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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