Metacognitive Training-Silver BeWell in Older Adults

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312241
• Other study ID #: MCT-Silver BeWell
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Brooke Viertel, PhD
• Phone: 040 7410 24014
• Email: b.viertel[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

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.

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. 2023 Apr 17. doi: 10.1007/s00406-023-01604-y. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Lancet Psychiatry. 2018 Oct;5(10):e24. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of sessions attended	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	Participants' appraisal of the training	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)
Secondary	Negative effects questionnaire (NEQ)	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)
Secondary	Depression (Beck Depression Inventory - II)	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)
Secondary	Dysfunctional beliefs (18-item Dysfunctional Attitudes Scale)	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)
Secondary	Mental Well-Being (Warwick-Edinburgh Mental Well-being Scale)	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)
Secondary	Resilience (Resilience Scale)	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)
Secondary	Rumination (Ruminative Responses Scale)	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)
Secondary	Loneliness (UCLA Loneliness scale)	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)
Secondary	Self-rated health (EQ5D5L Visual Analog Scale )	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)
Secondary	Session-specific effects	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