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

NCT03691402 | Completed

• 1 other identifier: LPEK-005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HRSD-24)

  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.

  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)

Secondary Outcomes (13)

• 16-item Quick Inventory for Depression (QIDS-C16)

  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)

• Beck Depression Inventory (BDI)

  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)

• Dysfunctional Attitudes Scale Form 18B (DAS-18B)

  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)

• Metacognitions Questionnaire (MCQ-30)

  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)

• Rosenberg Self-Esteem Scale

  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)

Study Arms (2)

MCT-Silver

EXPERIMENTAL

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.

Behavioral: MCT-Silver

Cognitive Remediation

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Remediation

Interventions

MCT-Silver 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.

MCT-Silver

Cognitive Remediation 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.

Cognitive Remediation

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• lifetime psychotic symptoms (i.e., hallucinations, delusions or mania)
• acute suicidal tendency
• intellectual disability (estimated IQ \< 70)
• dementia or other neurological illness

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

• 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.

  PMID: 39054326 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Steffen Moritz, PhD

  Universtitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Head of AG Clinical Neuropsychology

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 1, 2018
• Study Start: November 18, 2018
• Primary Completion: December 22, 2020
• Study Completion: December 22, 2020
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)