Depressive SymptomsNCT06312241
Metacognitive Training-Silver BeWell in Older Adults
A study testing Metacognitive Training-Silver BeWell in people with Depressive Symptoms and Well-Being, Psychological, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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.). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Well-Being, Psychological
- What is being tested?
- Metacognitive Training-Silver BeWell
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 21 Feb 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)).
Who cannot join
- Acute suicidality as assessed by BDI-II Item 9
- Dementia (MMSE < 24) or evidence of severe organic brain dysfunction
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Brooke Viertel, PhD, 040 7410 24014, b.viertel@uke.de
About this study
Official title: 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.).
Read the 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
- Conditions
- Depressive Symptoms, Well-Being, Psychological
- Being tested
- Metacognitive Training-Silver BeWell
- Keywords
- Metacognitive Training, intervention, older adults, cognitive-behavioral therapy, MCT-Silver
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Training-Silver BeWellBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive Training-Silver BeWell | Experimental | 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. Receives: Behavioral: Metacognitive Training-Silver BeWell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sessions attended
The total number of sessions attended (of 10) will be used to assess the feasibility of the intervention
Measured: 10 weeks (pre (t0)- to post (t1))
Secondary outcomes (10)
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
Measured: after each session weeks 1 through 10; post (10 weeks; t1) and follow-up (3 months; t2)
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
Measured: post (10 weeks; t1) and follow-up (3 months; t2)
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)
Measured: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
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)
Measured: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
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.
Measured: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
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.
Measured: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
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.
Measured: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
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.
Measured: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
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).
Measured: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
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
Measured: Before and after each session weeks 1 through 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start21 Feb 2024
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BViertel, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Brooke Viertel, PhD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312241
- Sponsor's protocol ID
- MCT-Silver BeWell
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35338378Miegel 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.
PubMed 37067579Jelinek 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.
PubMed 27230865Wu 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.
PubMed 32664001Yip 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.
PubMed 34400542Schaakxs 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.
PubMed 29887519Reynolds 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.
PubMed 36073714Schneider 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.
PubMed 37865342Schneider 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.
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.
PubMed 35736807Hauschildt 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.
PubMed 35274407
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptance and Efficacy of Metacognitive Training-Silver BeWell in Older Adults
- ClinicalTrials.gov ID
- NCT06312241
- Acronym / sponsor ID
- MCT-Silver BeWell
- Conditions
- Depressive Symptoms, Well-Being, Psychological
- Keywords
- Metacognitive Training, intervention, older adults, cognitive-behavioral therapy, MCT-Silver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metacognitive Training-Silver BeWell | Experimental | Behavioral: Metacognitive Training-Silver BeWellMCT-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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Acute suicidality as assessed by BDI-II Item 9
- Dementia (MMSE < 24) or evidence of severe organic brain dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive Training-Silver BeWellMetacognitive 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. | Behavioural | Metacognitive Training-Silver BeWell |
Primary outcome
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 secondary outcomes
Participants' appraisal of the training
Time frame: 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)
Depression (Beck Depression Inventory - II)
Time frame: 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)
Mental Well-Being (Warwick-Edinburgh Mental Well-being Scale)
Time frame: 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)
Rumination (Ruminative Responses Scale)
Time frame: 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)
Self-rated health (EQ5D5L Visual Analog Scale )
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 35338378Moritz 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.
- Background: PubMed 37067579Miegel 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.
- Background: PubMed 27230865Jelinek 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.
- Background: PubMed 32664001Wu 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.
- Background: PubMed 34400542Yip 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.
- Background: PubMed 29887519Schaakxs 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.
- Background: PubMed 36073714Reynolds 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.
- Background: PubMed 37865342Schneider 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.
- BackgroundSchneider 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.
- Background: PubMed 35736807Volz 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.
- Background: PubMed 35274407Hauschildt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brooke Viertel, PhD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Training-Silver BeWell in people with Depressive Symptoms and Well-Being, Psychological, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brooke Viertel, PhD (040 7410 24014, b.viertel@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sessions attended (time frame: 10 weeks (pre (t0)- to post (t1))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06312241, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.