Evaluation of Metacognitive Training for Depression in Later Life (MCT-Silver)
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborators:
Information provided by (Responsible Party):
Prof Dr. Steffen Moritz,Universitätsklinikum Hamburg-Eppendorf
Tracking Information | |||
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First Submitted Date ICMJE | September 25, 2018 | ||
First Posted Date ICMJE | October 1, 2018 | ||
Last Update Posted Date | October 1, 2018 | ||
Actual Study Start Date ICMJE | October 2018 | ||
Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Hamilton Depression Rating Scale (HRSD-24)[ Time Frame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) ] The 24-item version of the Hamilton Depression Rating Scale is an established clinician-rated assessment of depressive symptom severity and assesses psychological as well as somatic symptoms (scores range from 0-2 or 0-4) of depression. The clinician rates the severity of these symptoms based on the patient's report and his or her own observation. Scores range from 0-54. Based on the first 17 items, a score of 8-13 indicates mild depression, 14-18 indicates moderate depression, 19-22 indicates severe depression and scores greater than 23 indicate very severe depression. The scale has demonstrated good sensitivity and specificity among older adults (Mottram, Wilson & Copeland, 2001). The reliability and validity among older adult samples has also been confirmed (Korner et al., 2006). In terms of assessing change for the current trial, a greater reduction in depressive symptoms (i.e., change score) indicates better outcome. |
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Original Primary Outcome Measures ICMJE | Same as current | ||
Current Secondary Outcome Measures ICMJE |
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Descriptive Information | |||
Brief Title ICMJE | Evaluation of Metacognitive Training for Depression in Later Life (MCT-Silver) |
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Official Title ICMJE | A Randomized Controlled Trial Examining the Efficacy of Metacognitive Training for Depression in Later Life (MCT-Silver) |
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Brief Summary | The study will evaluate the efficacy of metacognitive training for depression in later life (MCT-Silver) vs. cognitive remediation (mybraintraining©) in reducing depressive symptoms among older adults. |
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Detailed Description | The study examines the efficacy of Metacognitive Training for depression in later life (MCT-Silver). The study intends to investigate the extent to which MCT-Silver leads to a significant reduction in depressive symptoms compared to an active control group (mybraintraining©) (primary outcome: change in clinician-assessed depressive symptoms from t0 to t1 and t2). Secondary outcomes include change in self-reported depressive symptoms and dysfunctional (meta) cognitive beliefs, as well as quality of life, rumination, self-reported anxiety, attitudes toward aging and neuropsychological functioning from t0 to t1 and t2. The study design is a randomized-controlled trial with one intervention group and one active control group. | ||
Study Type ICMJE | Interventional | ||
Study Phase | N/A | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional Masking Description:Double blind Primary Purpose: Treatment |
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Condition ICMJE | |||
Intervention ICMJE |
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Study Arms |
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Recruitment Information | |||
Recruitment Status ICMJE | Not yet recruiting | ||
Estimated Enrollment ICMJE |
86 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Estimated Study Completion Date | September 2020 | ||
Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria: - Able to give informed consent - age 60 years or older - diagnosis of a single episode or recurrent major depressive disorder (MDD) or dysthymia (verified by the MINI) - sufficient command of the German language - willingness to participate in intervention over a period of 8 weeks (participants who do not attend the intervention will also be included in the analysis) - Visual and auditory acuity adequate for neuropsychological testing and participation in group sessions Exclusion Criteria: - lifetime psychotic symptoms (i.e., hallucinations, delusions or mania) - acute suicidal tendency - intellectual disability (estimated IQ < 70) - dementia or other neurological illness | ||
Sex/Gender |
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Ages | 60 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers | No | ||
Listed Location Countries ICMJE | |||
Removed Location Countries | |||
Administrative Information | Has Data Monitoring Committee | No | |
U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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IPD Sharing Statement |
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Responsible Party | Prof Dr. Steffen Moritz,Universitätsklinikum Hamburg-Eppendorf | ||
Study Sponsor ICMJE | Universitätsklinikum Hamburg-Eppendorf | ||
Collaborators ICMJE | |||
Investigators ICMJE |
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PRS Account | Universitätsklinikum Hamburg-Eppendorf | ||
Verification Date | September 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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