Metacognitive Training-Silver BeWell in Older Adults

Not Applicable

Recruiting

• Conditions: Depressive Symptoms; Well-Being, Psychological
• Interventions: Behavioral: Metacognitive Training-Silver BeWell

• Registration Number: NCT06312241
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-02-19
• Study Start: 2024-02-21
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-06
• Last Update Submitted: 2024-03-06
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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)).

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Exclusion Criteria

• Acute suicidality as assessed by BDI-II Item 9
• Dementia (MMSE < 24) or evidence of severe organic brain dysfunction

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metacognitive Training-Silver BeWell	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.

Primary Outcome Measures

Name	Time	Method
Number of sessions attended	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

Secondary Outcome Measures

Name	Time	Method
Dysfunctional beliefs (18-item Dysfunctional Attitudes Scale)	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)
Participants' appraisal of the training	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
Resilience (Resilience Scale)	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.
Rumination (Ruminative Responses Scale)	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.
Loneliness (UCLA Loneliness scale)	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.
Depression (Beck Depression Inventory - II)	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)
Negative effects questionnaire (NEQ)	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
Mental Well-Being (Warwick-Edinburgh Mental Well-being Scale)	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.
Self-rated health (EQ5D5L Visual Analog Scale )	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).
Session-specific effects	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

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany