Evaluation of Metacognitive Training for Depression in Later Life (MCT-Silver)

NCT ID: NCT03691402

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-18

Study Completion Date

2020-12-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double blind

Study Groups

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MCT-Silver

Metacognitive training for depression in later life is a cognitive-behaviorally based group therapy, which focuses on helping participants gain (metacognitive) distance from their thought patterns that contribute to depression. Over 8 modules, MCT-Silver addresses issues specific to depression in later life, such as coping with physical changes and loss, as well as adapting to new (social) roles. The program also includes modules on identifying and (re-)defining values in later life and how one may move toward acceptance of situations that cannot be prevented or changed. MCT-Silver addresses cognitive and metacognitive biases that contribute to the onset and maintenance of depression through fun and engaging exercises, as well as using examples from daily life.

Group Type EXPERIMENTAL

MCT-Silver

Intervention Type BEHAVIORAL

Metacognitive training for depression in later life (MCT-Silver) is a cognitive-behaviorally based group therapy, which focuses on helping participants gain (metacognitive) distance from their thought patterns that contribute to depression. Over 8 modules, MCT-Silver addresses issues specific to depression in later life, such as coping with physical changes and loss, as well as adapting to new (social) roles. The program also includes modules on identifying and re-defining values in later life and how one may move toward acceptance of situations that cannot be prevented or changed. MCT-Silver addresses cognitive and metacognitive biases that contribute to the onset and maintenance of depression through fun and engaging exercises, as well as using examples from daily life.

Cognitive Remediation

mybraintraining© is a computer-based cognitive remediation program, which covers a wide range of neuropsychological exercises involving memory, reasoning, selective attention and psychomotor speed. The program is administered individually on personal computers and each session lasts approximately 45-60 min. To match the MCT-Silver group, participants will complete up to eight sessions of cognitive remediation.

Group Type ACTIVE_COMPARATOR

Cognitive Remediation

Intervention Type BEHAVIORAL

mybraintraining© is a computer-based cognitive remediation program, which covers a wide range of neuropsychological exercises involving memory, reasoning, selective attention and psychomotor speed. The program is administered individually on personal computers and each session lasts approximately 45-60 min. To match the MCT-Silver group, participants will complete up to eight sessions of cognitive remediation.

Interventions

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MCT-Silver

Metacognitive training for depression in later life (MCT-Silver) is a cognitive-behaviorally based group therapy, which focuses on helping participants gain (metacognitive) distance from their thought patterns that contribute to depression. Over 8 modules, MCT-Silver addresses issues specific to depression in later life, such as coping with physical changes and loss, as well as adapting to new (social) roles. The program also includes modules on identifying and re-defining values in later life and how one may move toward acceptance of situations that cannot be prevented or changed. MCT-Silver addresses cognitive and metacognitive biases that contribute to the onset and maintenance of depression through fun and engaging exercises, as well as using examples from daily life.

Intervention Type BEHAVIORAL

Cognitive Remediation

mybraintraining© is a computer-based cognitive remediation program, which covers a wide range of neuropsychological exercises involving memory, reasoning, selective attention and psychomotor speed. The program is administered individually on personal computers and each session lasts approximately 45-60 min. To match the MCT-Silver group, participants will complete up to eight sessions of cognitive remediation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Prof Dr. Steffen Moritz

Professor; Head of AG Clinical Neuropsychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steffen Moritz, PhD

Role: PRINCIPAL_INVESTIGATOR

Universtitätsklinikum Hamburg-Eppendorf

Locations

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University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

References

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Schneider BC, Veckenstedt R, Karamatskos E, Scheunemann J, Moritz S, Jelinek L, Miegel F. Change in negative mental filter is associated with depression reduction in metacognitive training for depression in older adults (MCT-Silver). Sci Rep. 2024 Jul 25;14(1):17120. doi: 10.1038/s41598-024-67063-0.

Reference Type DERIVED
PMID: 39054326 (View on PubMed)

Other Identifiers

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LPEK-005

Identifier Type: -

Identifier Source: org_study_id