DepressionDMKTNCT02415426
Metacognitive Training Program With Depression
An observational study of Depression, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Metacognitive Training Program during mild to moderate depression
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients from our ambulatorium
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik für Alterspsychiatrie, Gerontopsychiatrisches Zentrum Hegibach
Zurich, 8032
About this study
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.
- Conditions
- Depression
- Being tested
- Metacognitive Training Program during mild to moderate depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Training Program during mild to moderate depressionBehavioural
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of depression as measured by Becks Depression Inventory (BDI)
Measured: 14 months
Improvement of depression as measured by Hamilton Depression Scale (HAMD)
Measured: 14 months
Improvement of self-esteem as measured by Rosenberg Self-esteem Scale (RSE)
Measured: 14 months
Improvement of dysfunctional coping strategies as measured by 10-Item-Version of the Response Styles Questionnaire in German (RSQ-D)
Measured: 14 months
Improvement of dysfunctional coping strategies as measured by Dysfunctional Attitude Scale (DAS)
Measured: 14 months
Improvement of satisfaction and subjective well-being as measured by World Health Organization Quality of Life - short version (WHOQOL-BREF)
Measured: 14 months
Improvement of metacognitive thinking as measured by Metacognitions Questionnaire (MCQ)
Measured: 14 months
Improvement of cognition as measured by Consortium to Establish a Registry for Alzheimer's Disease (CERAD-Plus)
Measured: 14 months
Improvement of cognition as measured by 5-Point Test
Measured: 14 months
Improvement of cognition as measured by Regensburger Wortflüssigkeitstest (RWT)
Measured: 14 months
Improvement of cognition as measured by Tower of London
Measured: 14 months
Improvement of cognition as measured by Wechsler Memory Scale Revised (WMS-R)
Measured: 14 months
Improvement of cognition as measured by Trail Making Test (TMT)
Measured: 14 months
Improvement of cognition as measured by Wechsler Adult Intelligence Scale (WAIS-IV)
Measured: 14 months
Improvement of cognition as measured by Verbaler Lern- und Merkfähigkeitstest (VLMT)
Measured: 14 months
Improvement of cognition as measured by Testbatterie zur Aufmerksamkeitsprüfung (TAP)
Measured: 14 months
Improvement of cognition as measured by MWT
Measured: 14 months
Improvement of cognition as measured by Cartoon Test
Measured: 14 months
Improvement of cognition as measured by Faux Pas Test
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric University Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Egemen Savaskan, Psychiatric University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415426
- Sponsor's protocol ID
- D-MKT - 2014-0421
- Acronym
- DMKT
- Status last verified
- Nov 2017
- First submitted
- 26 Mar 2015
- Last updated
- 21 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Training Program With Depression
- ClinicalTrials.gov ID
- NCT02415426
- Acronym / sponsor ID
- DMKT / D-MKT - 2014-0421
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Psychiatric University Hospital, ZurichUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from our ambulatorium
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive Training Program during mild to moderate depressionDiagnostic 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). | Behavioural | – |
Primary outcome
Improvement of depression as measured by Becks Depression Inventory (BDI)
Time frame: 14 months
Improvement of depression as measured by Hamilton Depression Scale (HAMD)
Time frame: 14 months
Improvement of self-esteem as measured by Rosenberg Self-esteem Scale (RSE)
Time frame: 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
Improvement of dysfunctional coping strategies as measured by Dysfunctional Attitude Scale (DAS)
Time frame: 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
Improvement of metacognitive thinking as measured by Metacognitions Questionnaire (MCQ)
Time frame: 14 months
Improvement of cognition as measured by Consortium to Establish a Registry for Alzheimer's Disease (CERAD-Plus)
Time frame: 14 months
Improvement of cognition as measured by 5-Point Test
Time frame: 14 months
Improvement of cognition as measured by Regensburger Wortflüssigkeitstest (RWT)
Time frame: 14 months
Improvement of cognition as measured by Tower of London
Time frame: 14 months
Improvement of cognition as measured by Wechsler Memory Scale Revised (WMS-R)
Time frame: 14 months
Improvement of cognition as measured by Trail Making Test (TMT)
Time frame: 14 months
Improvement of cognition as measured by Wechsler Adult Intelligence Scale (WAIS-IV)
Time frame: 14 months
Improvement of cognition as measured by Verbaler Lern- und Merkfähigkeitstest (VLMT)
Time frame: 14 months
Improvement of cognition as measured by Testbatterie zur Aufmerksamkeitsprüfung (TAP)
Time frame: 14 months
Improvement of cognition as measured by MWT
Time frame: 14 months
Improvement of cognition as measured by Cartoon Test
Time frame: 14 months
Improvement of cognition as measured by Faux Pas Test
Time frame: 14 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of depression as measured by Becks Depression Inventory (BDI) (time frame: 14 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.