Metacognitive Training-Silver BeWell in Older Adults

NCT ID: NCT06312241

Last Updated: 2024-03-15

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

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-21

Study Completion Date

2025-12-31

Brief Summary

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The present study seeks to examine the feasibility, acceptance and efficacy of Metacognitive Training-Silver (MCT-Silver) BeWell among older adults (ages 60 years and older) delivered in a community setting (e.g., social-psychiatric community center, nursing homes, etc.).

Detailed Description

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Up to 20% of older adults have major depression and up to 30% have subclinical depressive symptoms (e.g., symptoms of depression that do not fulfill criteria for a major depressive episode). Given that depression in later life is associated with the onset of dementia and disability and that older adults have a higher risk of suicide and a longer time to remission, prompt treatment of subclinical depression and prevention of depression in later life is of importance. However, there is a lack of empirically-based, low-threshold and cost-effective group interventions for older adults, which can be delivered in community settings (e.g., community centers or nursing homes) by community mental health workers.

To fill this gap, the present study seeks to examine the feasibility, acceptance and efficacy of Metacognitive Training-Silver (MCT-Silver) BeWell among older adults (ages 60 years and older) delivered in a community setting (e.g., social-psychiatric community center, nursing homes, etc.). MCT-Silver BeWell is a standardized, cognitive-behavioral therapy based group intervention, which aims to improve insight for and reduce negative (meta)cognitive beliefs (e.g., negative mental filter), unhelpful behaviors (e.g., social withdrawal) and emotion-regulation (ER) strategies (e.g. rumination, avoidance of negative feelings) associated with the onset of depression. Like its forerunners, metacognitive training for psychosis (MCT) and depression in younger and middle-aged adults (D-MCT), MCT-Silver BeWell also aims at correcting information-processing biases (e.g., mood-congruent memory) associated with reduced mood and psychological well-being. In MCT-Silver BeWell sessions, psychoeducation regarding the association between negative (meta)cognitive beliefs and information-processing biases, ER strategies and behaviors with psychological well-being is presented and alternative, more helpful thoughts, strategies and skills are introduced and practiced with the aim of improving overall psychological well-being.

MCT-Silver for depression yielded significant effects beyond an active control group on self-reported depression, rumination and self-reported health in an outpatient setting with older adults with affective disorders, A pilot study of D-MCT among older adults also demonstrated the feasibility of the depression intervention in an inpatient setting and randomized clinical trials of D-MCT with adult sample have demonstrated the short and mid-term efficacy of D-MCT as well as session-specific effects, acceptance and (minimal) side effects.

In the current study, the investigator examine the acceptance, feasibility and efficacy of MCT-Silver BeWell among older adults. The number of sessions attended will serve as the primary outcome. Group attendance is expected to be high. Further outcomes include participants' acceptance (subjective ratings) as well as negative side effects of the intervention. It is expected that participants will rate the intervention positively and will report few negative side effects of the intervention. Other secondary outcomes include depression, resilience, loneliness, self-reported health, dysfunctional beliefs, and rumination

Conditions

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Depressive Symptoms Well-Being, Psychological

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metacognitive Training-Silver BeWell

MCT-Silver BeWell is a cognitive-behavioral therapy based group intervention, which aims to improve insight for and change negative (meta)cognitive beliefs (e.g., negative mental filter), information-processing biases (e.g., mood-congruent memory), unhelpful behaviors (e.g., social withdrawal) and emotion-regulation (ER) strategies (e.g. rumination, avoidance of negative feelings) associated with the onset of depression. The training represents a variant of MCT-Silver for depression in later life developed for older adults without clinical depression.

Group Type EXPERIMENTAL

Metacognitive Training-Silver BeWell

Intervention Type BEHAVIORAL

Metacognitive Training- Silver BeWell is a cognitive behavioral based group intervention, which focuses on helping participants gain (metacognitive) distance from thought and behavioral patterns as well as behaviors and ER-strategies that are implicated in the onset of depression and reduced overall mental well-being. In 10 modules, MCT-Silver addresses issues specific to 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, acceptance of negative feelings and resilience. In the training participants are made aware of information processing biases that have been shown to contribute to the onset of depression through engaging exercises using examples from daily life. Groups are comprised of up to 10 participants. Each session is 90 minutes.

Interventions

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Metacognitive Training-Silver BeWell

Metacognitive Training- Silver BeWell is a cognitive behavioral based group intervention, which focuses on helping participants gain (metacognitive) distance from thought and behavioral patterns as well as behaviors and ER-strategies that are implicated in the onset of depression and reduced overall mental well-being. In 10 modules, MCT-Silver addresses issues specific to 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, acceptance of negative feelings and resilience. In the training participants are made aware of information processing biases that have been shown to contribute to the onset of depression through engaging exercises using examples from daily life. Groups are comprised of up to 10 participants. Each session is 90 minutes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Informed consent
* Age 60 years or older
* Sufficient command of the German language
* Willingness to participate in intervention over a period of 10 weeks (participants who do not attend the intervention, but complete questionnaires will also be included in the analysis)
* Visual and auditory acuity adequate for participation in group sessions
* Ability to participate in the group setting (ability to participate in the group setting will be assessed during a screening interview (e.g., adequate social skills)).

Exclusion Criteria

* Acute suicidality as assessed by BDI-II Item 9
* Dementia (MMSE \< 24) or evidence of severe organic brain dysfunction
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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BViertel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brooke Viertel, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Brooke Viertel, PhD

Role: CONTACT

040 7410 24014

Facility Contacts

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Brooke Viertel, PhD

Role: primary

040 7410 24014

References

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Moritz S, Menon M, Balzan R, Woodward TS. Metacognitive training for psychosis (MCT): past, present, and future. Eur Arch Psychiatry Clin Neurosci. 2023 Jun;273(4):811-817. doi: 10.1007/s00406-022-01394-9. Epub 2022 Mar 25.

Reference Type BACKGROUND
PMID: 35338378 (View on PubMed)

Miegel F, Rubel J, Dietrichkeit M, Hagemann-Goebel M, Yassari AH, Balzar A, Scheunemann J, Jelinek L. Exploring mechanisms of change in the metacognitive training for depression. Eur Arch Psychiatry Clin Neurosci. 2024 Apr;274(3):739-753. doi: 10.1007/s00406-023-01604-y. Epub 2023 Apr 17.

Reference Type BACKGROUND
PMID: 37067579 (View on PubMed)

Jelinek L, Hauschildt M, Wittekind CE, Schneider BC, Kriston L, Moritz S. Efficacy of Metacognitive Training for Depression: A Randomized Controlled Trial. Psychother Psychosom. 2016;85(4):231-4. doi: 10.1159/000443699. Epub 2016 May 27. No abstract available.

Reference Type BACKGROUND
PMID: 27230865 (View on PubMed)

Wu JJ, Wang HX, Yao W, Yan Z, Pei JJ. Late-life depression and the risk of dementia in 14 countries: a 10-year follow-up study from the Survey of Health, Ageing and Retirement in Europe. J Affect Disord. 2020 Sep 1;274:671-677. doi: 10.1016/j.jad.2020.05.059. Epub 2020 May 26.

Reference Type BACKGROUND
PMID: 32664001 (View on PubMed)

Yip PSF, Zheng Y, Wong C. Demographic and epidemiological decomposition analysis of global changes in suicide rates and numbers over the period 1990-2019. Inj Prev. 2022 Apr;28(2):117-124. doi: 10.1136/injuryprev-2021-044263. Epub 2021 Aug 16.

Reference Type BACKGROUND
PMID: 34400542 (View on PubMed)

Schaakxs R, Comijs HC, Lamers F, Kok RM, Beekman ATF, Penninx BWJH. Associations between age and the course of major depressive disorder: a 2-year longitudinal cohort study. Lancet Psychiatry. 2018 Jul;5(7):581-590. doi: 10.1016/S2215-0366(18)30166-4. Epub 2018 Jun 18.

Reference Type BACKGROUND
PMID: 29887519 (View on PubMed)

Reynolds CF 3rd, Jeste DV, Sachdev PS, Blazer DG. Mental health care for older adults: recent advances and new directions in clinical practice and research. World Psychiatry. 2022 Oct;21(3):336-363. doi: 10.1002/wps.20996.

Reference Type BACKGROUND
PMID: 36073714 (View on PubMed)

Schneider BC, Veckenstedt R, Karamatskos E, Ahlf-Schumacher J, Gehlenborg J, Schultz J, Moritz S, Jelinek L. Efficacy and moderators of metacognitive training for depression in older adults (MCT-Silver): A randomized controlled trial. J Affect Disord. 2024 Jan 15;345:320-334. doi: 10.1016/j.jad.2023.10.118. Epub 2023 Oct 19.

Reference Type BACKGROUND
PMID: 37865342 (View on PubMed)

Schneider BC, Bücker L, Riker S, Karamatskos E, Jelinek L. A pilot study of metacognitive training (D-MCT) for older adults with depression. Zeitschrift für Neuropsychologie. 2018; 29.

Reference Type BACKGROUND

Volz HP, Stirnweiss J, Kasper S, Moller HJ, Seifritz E. Subthreshold depression - concept, operationalisation and epidemiological data. A scoping review. Int J Psychiatry Clin Pract. 2023 Mar;27(1):92-106. doi: 10.1080/13651501.2022.2087530. Epub 2022 Jun 23.

Reference Type BACKGROUND
PMID: 35736807 (View on PubMed)

Hauschildt M, Arlt S, Moritz S, Yassari AH, Jelinek L. Efficacy of metacognitive training for depression as add-on intervention for patients with depression in acute intensive psychiatric inpatient care: A randomized controlled trial. Clin Psychol Psychother. 2022 Sep;29(5):1542-1555. doi: 10.1002/cpp.2733. Epub 2022 Mar 21.

Reference Type BACKGROUND
PMID: 35274407 (View on PubMed)

Other Identifiers

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MCT-Silver BeWell

Identifier Type: -

Identifier Source: org_study_id

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