Clinical trial NCT02415426: Metacognitive Training Program With Depression
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Depression
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 2
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from our ambulatorium

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Improvement of depression as measured by Becks Depression Inventory (BDI)
timeFrame: 14 months
measure: Improvement of depression as measured by Hamilton Depression Scale (HAMD)
timeFrame: 14 months
measure: Improvement of self-esteem as measured by Rosenberg Self-esteem Scale (RSE)
timeFrame: 14 months
measure: Improvement of dysfunctional coping strategies as measured by 10-Item-Version of the Response Styles Questionnaire in German (RSQ-D)
timeFrame: 14 months
measure: Improvement of dysfunctional coping strategies as measured by Dysfunctional Attitude Scale (DAS)
timeFrame: 14 months
measure: Improvement of satisfaction and subjective well-being as measured by World Health Organization Quality of Life - short version (WHOQOL-BREF)
timeFrame: 14 months
measure: Improvement of metacognitive thinking as measured by Metacognitions Questionnaire (MCQ)
timeFrame: 14 months
measure: Improvement of cognition as measured by Consortium to Establish a Registry for Alzheimer's Disease (CERAD-Plus)
timeFrame: 14 months
measure: Improvement of cognition as measured by 5-Point Test
timeFrame: 14 months
measure: Improvement of cognition as measured by Regensburger Wortflüssigkeitstest (RWT)
timeFrame: 14 months
measure: Improvement of cognition as measured by Tower of London
timeFrame: 14 months
measure: Improvement of cognition as measured by Wechsler Memory Scale Revised (WMS-R)
timeFrame: 14 months
measure: Improvement of cognition as measured by Trail Making Test (TMT)
timeFrame: 14 months
measure: Improvement of cognition as measured by Wechsler Adult Intelligence Scale (WAIS-IV)
timeFrame: 14 months
measure: Improvement of cognition as measured by Verbaler Lern- und Merkfähigkeitstest (VLMT)
timeFrame: 14 months
measure: Improvement of cognition as measured by Testbatterie zur Aufmerksamkeitsprüfung (TAP)
timeFrame: 14 months
measure: Improvement of cognition as measured by MWT
timeFrame: 14 months
measure: Improvement of cognition as measured by Cartoon Test
timeFrame: 14 months
measure: Improvement of cognition as measured by Faux Pas Test
timeFrame: 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Klinik für Alterspsychiatrie, Gerontopsychiatrisches Zentrum Hegibach
Study officials:
References: