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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02415426
Other study ID # D-MKT - 2014-0421
Secondary ID
Status Terminated
Phase N/A
First received March 26, 2015
Last updated November 20, 2017
Start date June 2015
Est. completion date June 2017

Study information

Verified date November 2017
Source Psychiatric University Hospital, Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Metacognitive Training Program during mild to moderate depression
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).

Locations

Country Name City State
Switzerland Klinik für Alterspsychiatrie, Gerontopsychiatrisches Zentrum Hegibach Zürich

Sponsors (1)

Lead Sponsor Collaborator
Psychiatric University Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement of depression as measured by Becks Depression Inventory (BDI) 14 months
Primary Improvement of depression as measured by Hamilton Depression Scale (HAMD) 14 months
Primary Improvement of self-esteem as measured by Rosenberg Self-esteem Scale (RSE) 14 months
Primary Improvement of dysfunctional coping strategies as measured by 10-Item-Version of the Response Styles Questionnaire in German (RSQ-D) 14 months
Primary Improvement of dysfunctional coping strategies as measured by Dysfunctional Attitude Scale (DAS) 14 months
Primary Improvement of satisfaction and subjective well-being as measured by World Health Organization Quality of Life - short version (WHOQOL-BREF) 14 months
Primary Improvement of metacognitive thinking as measured by Metacognitions Questionnaire (MCQ) 14 months
Primary Improvement of cognition as measured by Consortium to Establish a Registry for Alzheimer's Disease (CERAD-Plus) 14 months
Primary Improvement of cognition as measured by 5-Point Test 14 months
Primary Improvement of cognition as measured by Regensburger Wortflüssigkeitstest (RWT) 14 months
Primary Improvement of cognition as measured by Tower of London 14 months
Primary Improvement of cognition as measured by Wechsler Memory Scale Revised (WMS-R) 14 months
Primary Improvement of cognition as measured by Trail Making Test (TMT) 14 months
Primary Improvement of cognition as measured by Wechsler Adult Intelligence Scale (WAIS-IV) 14 months
Primary Improvement of cognition as measured by Verbaler Lern- und Merkfähigkeitstest (VLMT) 14 months
Primary Improvement of cognition as measured by Testbatterie zur Aufmerksamkeitsprüfung (TAP) 14 months
Primary Improvement of cognition as measured by MWT 14 months
Primary Improvement of cognition as measured by Cartoon Test 14 months
Primary Improvement of cognition as measured by Faux Pas Test 14 months
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