Metacognitive Training-Silver BeWell in Older Adults

March 6, 2024 updated by: BViertel, Universitätsklinikum Hamburg-Eppendorf

Feasibility, Acceptance and Efficacy of Metacognitive Training-Silver BeWell in Older Adults

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.).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Brooke Viertel, PhD
  • Phone Number: 040 7410 24014
  • Email: b.viertel@uke.de

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of sessions attended
Time Frame: 10 weeks (pre (t0)- to post (t1))
The total number of sessions attended (of 10) will be used to assess the feasibility of the intervention
10 weeks (pre (t0)- to post (t1))

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' appraisal of the training
Time Frame: after each session weeks 1 through 10; post (10 weeks; t1) and follow-up (3 months; t2)
Participant's acceptance of the training as measured by a self-developed questionnaire; single items assessing patients' acceptance of the training (1 = low acceptance; 5 = high acceptance); high scores indicate better appraisal of the intervention
after each session weeks 1 through 10; post (10 weeks; t1) and follow-up (3 months; t2)
Negative effects questionnaire (NEQ)
Time Frame: post (10 weeks; t1) and follow-up (3 months; t2)
Negative effects of the intervention will be assessed by the Negative Effects Questionnaire "negative effects of treatment" score (minimum = 0; maximum = 128); higher scores indicate more negative side effects
post (10 weeks; t1) and follow-up (3 months; t2)
Depression (Beck Depression Inventory - II)
Time Frame: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
Change in self-assessed depression as measured by the Beck Depression Inventory-II (BDI-II) from baseline to post-assessment (t0 to t1) and follow-up (t0 to t2); 21 items are assessed on a 4-point Likert scale; higher scores indicate more depressive symptoms; (minimum score = 0; maximum score = 63)
baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
Dysfunctional beliefs (18-item Dysfunctional Attitudes Scale)
Time Frame: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
Change in dysfunctional beliefs as measured by the 18-item Dysfunctional Attitude Scale (DAS-18B) from baseline to post-assessment (t0 to t1) and follow-up (t0 to t2); 18 items are assessed on a 7-point Likert scale; high score indicates more dysfunctional beliefs (minimum = 18; maximum = 126)
baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
Mental Well-Being (Warwick-Edinburgh Mental Well-being Scale)
Time Frame: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
Change in mental well-being as measured by the short version of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) from baseline to post-assessment (t0 to t1) and follow-up (t0 to t2); 14 items assessed on a 5-point Likert scale (minimum = 14; maximum = 70). Higher scores indicate better well-being.
baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
Resilience (Resilience Scale)
Time Frame: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
Change in resilience as measured by the 13-item Resilience Scale from baseline to post-assessment (t0 to t1) and follow-up (t0 to t2); 13 items assessed on a 7-point Likert scale (minimum = 13; maximum = 91). Higher scores indicate more resilience.
baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
Rumination (Ruminative Responses Scale)
Time Frame: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
Change in rumination measured by the Ruminative Response Scale (RRS) from baseline to post-assessment (t0 to t1) and follow-up (t0 to t2); 10 items assessed on a 4-point Likert scale (minimum = 10; maximum = 40). Higher scores indicate more ruminative behaviors.
baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
Loneliness (UCLA Loneliness scale)
Time Frame: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
Change in loneliness as measured by the 3-item UCLA Loneliness scale from baseline to post-assessment (t0 to t1) and follow-up (t0 to t2); 3-items assessed on a 4-point Likert scale (minimum = 4; maximum = 12). Higher scores indicate more loneliness.
baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
Self-rated health (EQ5D5L Visual Analog Scale )
Time Frame: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
Change in self-rated health as measured by the EQ5D5L Visual Analog Scale from baseline to post-assessment (t0 to t1) and follow-up (t0 to t2); Rating Scale 0 (worst health possible) - 100 (best health possible).
baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
Session-specific effects
Time Frame: Before and after each session weeks 1 through 10
Before and after each session during weeks 1 through 10, participants will complete a 40-item questionnaire regarding changes in depressive symptoms, negative (meta)cognitive beliefs and attitudes associated with depression, which are targeted in the MCT-Silver BeWell. Items are assessed on a 6-point LIkert scale (minimum = 40; maximum = 240); high scores indicate more negative beliefs / attitudes
Before and after each session weeks 1 through 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Brooke Viertel, PhD, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCT-Silver BeWell

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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