Depression in Old AgeNCT06042283
Efficacy of Metacognitive Training in Older Adults With Depression
A study testing Metacognitive Training-Silver in people with Depression in Old Age, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Effective pharmacological and psychological treatments for depression are available. However, treatment modalities are not accessible to all patients diagnosed with depression. Furthermore, some individuals who access treatment drop out and relapse after treatment. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression in Old Age
- What is being tested?
- Metacognitive Training-Silver
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 30 Oct 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 60 years and over,
- Diagnosis of depression by a psychiatrist according to DSM-V criteria,
- No change in psychopharmacological medications used within 3 months before the Metacognitive Training-Silver program,
- No psychiatric hospitalization in the last 3 months,
- No problems with vision, hearing, and understanding,
- Being literate,
Who cannot join
- Individuals under 60 years of age,
- Comorbid with a diagnosis of depression to the extent that it interferes with the understanding of the Metacognitive Training-Silver program;
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpaşa
Istanbul, Istanbul, 34381
About this study
Official title: Assessing the Efficacy of Metacognitive Training on Depressive Symptoms, Dysfunctional Attitudes and Metacognition in Older Adults Diagnosed With Depression
Effective pharmacological and psychological treatments for depression are available. However, treatment modalities are not accessible to all patients diagnosed with depression. Furthermore, some individuals who access treatment drop out and relapse after treatment. Improving treatment modalities for depression is important given the rates of individuals diagnosed worldwide, and rather than developing new treatments, there is a need to explore how existing treatment modalities can be improved and implemented in a simpler and more cost-effective way. To address this need, Metacognitive Training for Depression (DMCT) was developed as a low-cost, easy-to-implement, cognitive behavioral therapy-based group intervention. The aim of Metacognitive Training is to reduce depressive symptoms by working with the patient's cognitive biases from a metacognitive perspective. The effectiveness of this method, which has been proven effective by studies in the literature, is presented with a pilot study on older adults in 2018. Since the studies evaluating the effectiveness of the Metacognitive Training-Silver program are limited and it has not yet been adapted to Turkish culture, this study aims to evaluate the effectiveness of the Metacognitive Training-Silver program in older adults diagnosed with depression.
Read the detailed description
According to the Global Burden of Disease (GBD-2019) report, mental disorders have been at the top of the global burden of disease list between 1990 and 2019. Depression ranks first among mental disorders with disability and psychosocial dependence. The worldwide prevalence rate of depression is 3.8% and it is a common disorder. The prevalence rate in adults is 5%, and the prevalence rate in adults aged 60 and over is 5.7%. According to the 2021 data from the US Centers for Disease Control and Prevention, compared to the general population, the rate of depression is 13.5% higher in older adults who need home healthcare services and 11.5% higher in hospitalized older adults. A recent systematic review and meta-analysis (2022) found that the global prevalence rate of depression in older adults was 28.4% and that the prevalence of depression in older adults is high, although there are variations by geographical location, diagnostic/screening tools, sample size, representativeness, and study quality. The isolation measures taken to prevent the spread of the COVID-19 pandemic have negative psychological effects on the protection of vulnerable groups, including older adults. Therefore, the pandemic is reported to have led to a significant increase in major depression cases globally, with an estimated 28.1% increase. With the COVID-19 pandemic, there is an increase in the demand for mental health services due to the increase in the incidence of depression and anxiety. Depression is more than a short-term emotional response to mood swings and psychological difficulties experienced in daily life. Especially recurrent and moderate or severe depression is an important health problem. The individual's daily life is negatively affected, functionality decreases and/or suicide may occur.
Depression is a serious mental disorder characterized by symptoms such as depressed mood or loss of interest/desire. In addition to these important symptoms, DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria include sleep problems, changes in appetite/weight, psychomotor restlessness/agitation, loss of energy, concentration problems, feelings of worthlessness or guilt, and recurrent suicidal thoughts. Over time, this illness leads to cognitive and social dysfunction.
In the treatment of depression, multimodal treatment options need to be carried out simultaneously. Although there are known effective treatments for mental disorders, more than 75% of people in low- and middle-income countries do not receive treatment. Barriers to effective care include a lack of financial resources, lack of legal regulations, lack of trained health professionals, and stigma. Therefore, psychotherapeutic interventions in inpatient/outpatient mental health facilities for psychosocial rehabilitation are insufficient, and effective care management is needed to address this problem.
In the treatment of depression, only medication can be used due to various factors such as patient preference and economic reasons. However, despite medication, the disability and decreased functionality seen in patients are not sufficient for the rehabilitation of the patient. Insight into the disease and low compliance with treatment emphasizes the need for psychotherapies and psychosocial interventions. In this sense, cognitive-behavioral therapy approaches and family interventions are an essential complement to psychopharmacology.
Metacognitive Training (MCT) was created by Steffen Moritz (2007) focusing on psychosis. Studies conducted using MCT show that MCT is beneficial in patients with schizophrenia and psychosis, reduces the severity of delusions, and shows a positive effect even after 6 months of follow-up. Following these results, Metacognitive Training for Depression (D-MCT), which focuses on cognitive biases specific to depression, was developed based on the Metacognitive Training for Psychosis program. Metacognitive Training for Depression is a new treatment option for depression and is a variant of cognitive behavioral therapy that adopts a metacognitive perspective by focusing on changing cognitive biases and dysfunctional attitudes. In the first pilot study conducted by Jelinek et al. (2013), it was proven that there was a significant decrease in depressive symptoms, cognitive distortions, and rumination and an increase in self-esteem. In other randomized controlled studies conducted by Jelinek and colleagues, at the end of Metacognitive Training for Depression and at 6-month follow-up, it was determined that there was more improvement in depressive symptoms and a decrease in dysfunctional metacognitive beliefs. In secondary analyses conducted 3.5 years later, it was found that positive effects were still seen in the groups where Metacognitive Training for Depression was applied. The adaptation study of the Metacognitive Training for Depression program to Turkish culture was conducted by Okyay and Taş (2017) and the results of the study show that there is a significant difference in the data of Rumi Positive \& Negative Scales, Ruminative Reactions Scale and Self-Efficacy Scale in depression patients who were administered this program. In another study (2022), after Metacognitive Training for Depression, there was a decrease in the Beck Depression Scale and Cognitive Distortions Scale scores, depression and cognitive distortion levels of patients.
The presentation of the positive effects of Metacognitive Training for Depression with high level of evidence has contributed to the development of the Metacognitive Training for Older Adults (MCT-Silver) program for depression in older adults. Metacognitive Training-Silver focuses on helping individuals move away from thought patterns that feed/support depression and focuses on physical changes that occur during the aging process, coping with loss and adapting to new social roles. Metacognitive Training-Silver addresses how to identify and reinterpret values in life for individuals aged 60 and over and how to move towards accepting situations that cannot be prevented/changed. In the first pilot study (2018) of the Metacognitive Training-Silver program, a significant reduction in depressive symptoms and dysfunctional attitudes was found. Therefore, more studies are needed to prove the effectiveness of the Metacognitive Training-Silver program.
The Metacognitive Training-Silver program has not yet been adapted to Turkish culture and studies are needed to prove its effectiveness in Turkey. In this direction, a randomized controlled trial is planned to evaluate the effectiveness of the Metacognitive Training-Silver program in older adults diagnosed with depression.
- Conditions
- Depression in Old Age
- Being tested
- Metacognitive Training-Silver
- Keywords
- geriatric depression, psychotherapy, metacognitive training-silver, thought distortions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Training-SilverBehavioural
The Metacognitive Training-Silver program includes the following topics: Thinking and Reasoning 1 (module 1), Memory (module 2), Thinking and Reasoning 2 (module 3), Self-Esteem (module 4), Thinking and Reasoning 3 (module 5), Behaviors and Strategies (module 6), Thinking and Reasoning 4 (module 7) and Perception of Feelings (module 8).
Each session is planned to last 45-60 minutes. Materials will be used in the Metacognitive Training-Silver program are PPT (Power Point Presentations) slides, videos, homework exercises, and yellow-red cards.
Metacognitive Training-Silver is planned to be applied face-to-face in 3 groups (12, 10, and 10 people) at scheduled times in a quiet room suitable for the group. In order to increase compliance with the Metacognitive Training-Silver program, the sessions will be applied during the routine treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in this group will have Metacognitive Training-Silver program. Metacognitive Training-Silver program is an eight-module training that focuses on common cognitive problems and dysfunctional attitudes, beliefs and prejudices in solving problems seen in depression. The purpose of the sessions is to convey information about false beliefs and cognitive distortions, and to help sick individuals think critically, convey their thoughts, and acquire new problem-solving strategies through exercises. Receives: Behavioral: Metacognitive Training-Silver |
| Control group | No intervention | All participants in the control group will continue the treatment process determined in the routine. In this process, the patient participates in counseling and/or psychotherapy, ECT (electroconvulsive therapy) sessions, and psychopharmacological drugs. The control group will not participate in the Metacognitive Training-Silver program, an interview consisting of one session is planned considering for the placebo effect. At the end of the study, the Metacognitive Training-Silver program will be carried out with the voluntary participants in the control group, taking into account the ethics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck's Depression Inventory (BDI): Time 1
The purpose of the inventory, developed by Aaron T. Beck et al. in 1978, is to measure the severity and change of depressive symptoms in the individual. The Turkish validity and reliability study was carried out by Hisli Şahin. The scale provides a 4-point Likert-type measurement consisting of 21 items. In the scale, the individual is asked to indicate how he or she has felt in the last week. The high score obtained from the scale shows a high level of depression. (Hisli 1989a; Hisli 1989b). The BDI will be used at the beginning of the Metacognitive Training-Silver.
Measured: BDI will be applied on the first day of Metacognitive Training-Silver to both groups.
Beck's Depression Inventory (BDI): Time 2
The purpose of the inventory, developed by Aaron T. Beck et al. in 1978, is to measure the severity and change of depressive symptoms in the individual. The Turkish validity and reliability study was carried out by Hisli Şahin. The scale provides a 4-point Likert-type measurement consisting of 21 items. In the scale, the individual is asked to indicate how he or she has felt in the last week. The high score obtained from the scale shows a high level of depression. (Hisli 1989a; Hisli 1989b). The BDI will be used at the end of the Metacognitive Training-Silver.
Measured: BDI will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.
Beck's Depression Inventory (BDI): Time 3
The purpose of the inventory, developed by Aaron T. Beck et al. in 1978, is to measure the severity and change of depressive symptoms in the individual. The Turkish validity and reliability study was carried out by Hisli Şahin. The scale provides a 4-point Likert-type measurement consisting of 21 items. In the scale, the individual is asked to indicate how he or she has felt in the last week. The high score obtained from the scale shows a high level of depression. (Hisli 1989a; Hisli 1989b). The BDI will be used for follow-up evaluation up to 3 months after the final program.
Measured: BDI will be reapplied for a follow up evaluation, up to 3 months after the final program, in both groups.
Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 1
It was developed by Weissman and Beck (1987) as A and B forms, each consisting of 40 items, in order to detect intermediate beliefs that cause depression or anxiety in individuals and to learn their frequency (Weissman and Beck, 1978). However, the validity and reliability study of the revised and abbreviated version of the form was conducted by Batmaz and Özdel (2016) in order to be more useful for practitioners and those who filled out the scale. The scale, which consists of 13 items in the 7-Likert type, has two sub-dimensions as "Perfectionism/Achievement" (first 8 items) and "Need for Approval/Dependency" (last 5 items). If the total scores obtained are high, it indicates that individuals have more dysfunctional attitudes (Batmaz and Özdel, 2016). The DAS-R-TR will be used at the beginning of the Metacognitive Training-Silver.
Measured: DAS-R-TR will be applied on the first day of Metacognitive Training-Silver to both groups.
Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 2
It was developed by Weissman and Beck (1987) as A and B forms, each consisting of 40 items, in order to detect intermediate beliefs that cause depression or anxiety in individuals and to learn their frequency (Weissman and Beck, 1978). However, the validity and reliability study of the revised and abbreviated version of the form was conducted by Batmaz and Özdel (2016) in order to be more useful for practitioners and those who filled out the scale. The scale, which consists of 13 items in the 7-Likert type, has two sub-dimensions as "Perfectionism/Achievement" (first 8 items) and "Need for Approval/Dependency" (last 5 items). If the total scores obtained are high, it indicates that individuals have more dysfunctional attitudes (Batmaz and Özdel, 2016). The DAS-R-TR will be used at the end of the Metacognitive Training-Silver.
Measured: DAS-R-TR will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.
Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 3
It was developed by Weissman and Beck (1987) as A and B forms, each consisting of 40 items, in order to detect intermediate beliefs that cause depression or anxiety in individuals and to learn their frequency (Weissman and Beck, 1978). However, the validity and reliability study of the revised and abbreviated version of the form was conducted by Batmaz and Özdel (2016) in order to be more useful for practitioners and those who filled out the scale. The scale, which consists of 13 items in the 7-Likert type, has two sub-dimensions as "Perfectionism/Achievement" (first 8 items) and "Need for Approval/Dependency" (last 5 items). If the total scores obtained are high, it indicates that individuals have more dysfunctional attitudes (Batmaz and Özdel, 2016). The DAS-R-TR will be used for follow-up evaluation up to 3 months after the final program.
Measured: DAS-R-TR will be reapplied for a follow up evaluation, up to 3 months after the final program, in both groups.
Metacognition Questionnaire-30 (MCQ-30): Time 1
The MCQ-30 assesses individual differences in unhelpful metacognitions which may contribute to obsessive and compulsive symptoms, pathological worry, and underpin trait anxiety. The scale was developed based on the metacognitive model by Cartwright-Hatton \& Wells (65 items, 1997) and was shortened by Wells \& Cartwright-Hatton (30 items, 2004). The Turkish study was carried out by Yılmaz et al. and Tosun \& Irak in 2008 (Yılmaz et al., 2008; Tosun and Irak, 2008). According to the study of Tosun \& Irak (2008), a 4-point Likert-type scale consists five sub-dimensions: (Lack of) Cognitive Confidence, Positive Beliefs about Worry, Cognitive Self-Consciousness, Negative Beliefs about Uncontrollability and Danger, and Need to Control Thoughts. An increase in the score indicates an increase in pathological metacognitive activity (Tosun \& Irak, 2008). The MCQ-30 will be used at the beginning of the Metacognitive Training-Silver.
Measured: MCQ-30 will be applied on the first day of Metacognitive Training-Silver to both groups.
Metacognition Questionnaire-30 (MCQ-30): Time 2
The MCQ-30 assesses individual differences in unhelpful metacognitions which may contribute to obsessive and compulsive symptoms, pathological worry, and underpin trait anxiety. The scale was developed based on the metacognitive model by Cartwright-Hatton \& Wells (65 items, 1997) and was shortened by Wells \& Cartwright-Hatton (30 items, 2004). The Turkish study was carried out by Yılmaz et al. and Tosun \& Irak in 2008 (Yılmaz et al., 2008; Tosun and Irak, 2008). According to the study of Tosun \& Irak (2008), a 4-point Likert-type scale consists five sub-dimensions: (Lack of) Cognitive Confidence, Positive Beliefs about Worry, Cognitive Self-Consciousness, Negative Beliefs about Uncontrollability and Danger, and Need to Control Thoughts. An increase in the score indicates an increase in pathological metacognitive activity (Tosun \& Irak, 2008). The MCQ-30 will be used at the end of the Metacognitive Training-Silver.
Measured: MCQ-30 will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.
Metacognition Questionnaire-30 (MCQ-30): Time 3
The MCQ-30 assesses individual differences in unhelpful metacognitions which may contribute to obsessive and compulsive symptoms, pathological worry, and underpin trait anxiety. The scale was developed based on the metacognitive model by Cartwright-Hatton \& Wells (65 items, 1997) and was shortened by Wells \& Cartwright-Hatton (30 items, 2004). The Turkish study was carried out by Yılmaz et al. and Tosun \& Irak in 2008 (Yılmaz et al., 2008; Tosun and Irak, 2008). According to the study of Tosun \& Irak (2008), a 4-point Likert-type scale consists five sub-dimensions: (Lack of) Cognitive Confidence, Positive Beliefs about Worry, Cognitive Self-Consciousness, Negative Beliefs about Uncontrollability and Danger, and Need to Control Thoughts. An increase in the score indicates an increase in pathological metacognitive activity (Tosun \& Irak, 2008). The MCQ-30 will be used for follow-up evaluation up to 3 months after the final program.
Measured: MCQ-30 will be applied on the first day of Metacognitive Training-Silver to both groups.
The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 1
The attitudes to ageing questionnaire was developed to provide a standard way of measuring attitudes to ageing from the perspective of older people. The scale was developed within the scope of a multi-center project supported by the EU 5th Framework Program to determine the perception level to aging of elderly. The Turkish adaptation and psychometric properties of the scale were studied by Eser et al. in 2011. The scale is a 5-point Likert-type scale consisting of three sub-dimensions (Psychosocial Loss; Physical Change and Psychological Growth) and a total of 24 items. As the total score of the scale increases, the attitude towards the related dimension also increases positively. (Eser et al. 2011). The EAAQ will be used at the beginning of the Metacognitive Training-Silver.
Measured: EAAQ will be applied on the first day of Metacognitive Training-Silver to both groups.
The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 2
The attitudes to ageing questionnaire was developed to provide a standard way of measuring attitudes to ageing from the perspective of older people. The scale was developed within the scope of a multi-center project supported by the EU 5th Framework Program to determine the perception level to aging of elderly. The Turkish adaptation and psychometric properties of the scale were studied by Eser et al. in 2011. The scale is a 5-point Likert-type scale consisting of three sub-dimensions (Psychosocial Loss; Physical Change and Psychological Growth) and a total of 24 items. As the total score of the scale increases, the attitude towards the related dimension also increases positively. (Eser et al. 2011). The EAAQ will be used at the end of the Metacognitive Training-Silver.
Measured: EAAQ will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.
The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 3
The attitudes to ageing questionnaire was developed to provide a standard way of measuring attitudes to ageing from the perspective of older people. The scale was developed within the scope of a multi-center project supported by the EU 5th Framework Program to determine the perception level to aging of elderly. The Turkish adaptation and psychometric properties of the scale were studied by Eser et al. in 2011. The scale is a 5-point Likert-type scale consisting of three sub-dimensions (Psychosocial Loss; Physical Change and Psychological Growth) and a total of 24 items. As the total score of the scale increases, the attitude towards the related dimension also increases positively. (Eser et al. 2011). The EAAQ will be used for follow-up evaluation up to 3 months after the final program.
Measured: EAAQ will be applied on the first day of Metacognitive Training-Silver to both groups.
Secondary outcomes (1)
Personal Information Form (Sociodemographic Characteristics and Clinical Data)
The personal information form prepared by the researchers is a 16-question form containing sociodemographic characteristics such as age, gender, marital status, educational status, and depression-related clinical data such as diagnosis time, and treatment method (pharmacotherapy and/or psychotherapy) etc. This form will be applied on the first day of the program to all participants and will be collected once.
Measured: Personal Information Form will be applied on the first day of the first session of Metacognitive Training-Silver on both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start15 Sep 2023
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Depression in Old AgeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lect. Merve MURAT MEHMED ALİ, Ph.D.(c), MSN, RN, Istanbul University - Cerrahpasa
- Investigators
- Merve MURAT MEHMED ALİ, MSc, RN, Principal investigator, Istanbul University - CerrahpasaSevim BUZLU, Prof, PhD, RN, Study chair, Istanbul University - CerrahpasaLara Guedes de Pinho, Assoc Prof, PhD, RN, Study chair, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042283
- Sponsor's protocol ID
- 01
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2023
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD (Individual Participant Data) available. After the study is completed, the publication which includes the data results will be available.
Publications
Batmaz S, Ozdel K. Psychometric Properties of the Revised and Abbreviated form of the Turkish Version of the Dysfunctional Attitude Scale. Psychol Rep. 2016 Feb;118(1):180-198. doi: 10.1177/0033294116628349.
PubMed 29693528COVID-19 Mental Disorders Collaborators. Global prevalence and burden of depressive and anxiety disorders in 204 countries and territories in 2020 due to the COVID-19 pandemic. Lancet. 2021 Nov 6;398(10312):1700-1712. doi: 10.1016/S0140-6736(21)02143-7. Epub 2021 Oct 8.
PubMed 34634250Cuijpers P, Sijbrandij M, Koole SL, Andersson G, Beekman AT, Reynolds CF 3rd. Adding psychotherapy to antidepressant medication in depression and anxiety disorders: a meta-analysis. World Psychiatry. 2014 Feb;13(1):56-67. doi: 10.1002/wps.20089.
PubMed 24497254Evans-Lacko S, Aguilar-Gaxiola S, Al-Hamzawi A, Alonso J, Benjet C, Bruffaerts R, Chiu WT, Florescu S, de Girolamo G, Gureje O, Haro JM, He Y, Hu C, Karam EG, Kawakami N, Lee S, Lund C, Kovess-Masfety V, Levinson D, Navarro-Mateu F, Pennell BE, Sampson NA, Scott KM, Tachimori H, Ten Have M, Viana MC, Williams DR, Wojtyniak BJ, Zarkov Z, Kessler RC, Chatterji S, Thornicroft G. Socio-economic variations in the mental health treatment gap for people with anxiety, mood, and substance use disorders: results from the WHO World Mental Health (WMH) surveys. Psychol Med. 2018 Jul;48(9):1560-1571. doi: 10.1017/S0033291717003336. Epub 2017 Nov 27.
PubMed 29173244GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022 Feb;9(2):137-150. doi: 10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10.
PubMed 35026139Hu T, Zhao X, Wu M, Li Z, Luo L, Yang C, Yang F. Prevalence of depression in older adults: A systematic review and meta-analysis. Psychiatry Res. 2022 May;311:114511. doi: 10.1016/j.psychres.2022.114511. Epub 2022 Mar 16.
PubMed 35316691Islam N, Sharp SJ, Chowell G, Shabnam S, Kawachi I, Lacey B, Massaro JM, D'Agostino RB Sr, White M. Physical distancing interventions and incidence of coronavirus disease 2019: natural experiment in 149 countries. BMJ. 2020 Jul 15;370:m2743. doi: 10.1136/bmj.m2743.
PubMed 32669358Jelinek 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 27230865Jelinek L, Van Quaquebeke N, Moritz S. Cognitive and Metacognitive Mechanisms of Change in Metacognitive Training for Depression. Sci Rep. 2017 Jun 14;7(1):3449. doi: 10.1038/s41598-017-03626-8.
PubMed 28615651Jelinek L, Faissner M, Moritz S, Kriston L. Long-term efficacy of Metacognitive Training for Depression (D-MCT): A randomized controlled trial. Br J Clin Psychol. 2019 Sep;58(3):245-259. doi: 10.1111/bjc.12213. Epub 2018 Dec 16.
PubMed 30556583Liu YC, Tang CC, Hung TT, Tsai PC, Lin MF. The Efficacy of Metacognitive Training for Delusions in Patients With Schizophrenia: A Meta-Analysis of Randomized Controlled Trials Informs Evidence-Based Practice. Worldviews Evid Based Nurs. 2018 Apr;15(2):130-139. doi: 10.1111/wvn.12282. Epub 2018 Feb 28.
PubMed 29489070Moritz S, Woodward TS. Metacognitive training in schizophrenia: from basic research to knowledge translation and intervention. Curr Opin Psychiatry. 2007 Nov;20(6):619-25. doi: 10.1097/YCO.0b013e3282f0b8ed.
PubMed 17921766Perini G, Cotta Ramusino M, Sinforiani E, Bernini S, Petrachi R, Costa A. Cognitive impairment in depression: recent advances and novel treatments. Neuropsychiatr Dis Treat. 2019 May 10;15:1249-1258. doi: 10.2147/NDT.S199746. eCollection 2019.
PubMed 31190831Skoog I. COVID-19 and mental health among older people in Sweden. Int Psychogeriatr. 2020 Oct;32(10):1173-1175. doi: 10.1017/S104161022000143X. Epub 2020 Jul 8. No abstract available.
PubMed 32635950van Oosterhout B, Smit F, Krabbendam L, Castelein S, Staring AB, van der Gaag M. Metacognitive training for schizophrenia spectrum patients: a meta-analysis on outcome studies. Psychol Med. 2016 Jan;46(1):47-57. doi: 10.1017/S0033291715001105. Epub 2015 Jul 20.
PubMed 26190517
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Metacognitive Training on Depressive Symptoms, Dysfunctional Attitudes and Metacognition in Older Adults Diagnosed With Depression
- ClinicalTrials.gov ID
- NCT06042283
- Acronym / sponsor ID
- 01
- Conditions
- Depression in Old Age
- Keywords
- geriatric depression, psychotherapy, metacognitive training-silver, thought distortions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 18 Sep 2023 (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.
Effective pharmacological and psychological treatments for depression are available. However, treatment modalities are not accessible to all patients diagnosed with depression. Furthermore, some individuals who access treatment drop out and relapse after treatment. Improving treatment modalities for depression is important given the rates of individuals diagnosed worldwide, and rather than developing new treatments, there is a need to explore how existing treatment modalities can be improved and implemented in a simpler and more cost-effective way. To address this need, Metacognitive Training for Depression (DMCT) was developed as a low-cost, easy-to-implement, cognitive behavioral therapy-based group intervention. The aim of Metacognitive Training is to reduce depressive symptoms by working with the patient's cognitive biases from a metacognitive perspective. The effectiveness of this method, which has been proven effective by studies in the literature, is presented with a pilot study on older adults in 2018. Since the studies evaluating the effectiveness of the Metacognitive Training-Silver program are limited and it has not yet been adapted to Turkish culture, this study aims to evaluate the effectiveness of the Metacognitive Training-Silver program in older adults diagnosed with depression.
Detailed description
According to the Global Burden of Disease (GBD-2019) report, mental disorders have been at the top of the global burden of disease list between 1990 and 2019. Depression ranks first among mental disorders with disability and psychosocial dependence. The worldwide prevalence rate of depression is 3.8% and it is a common disorder. The prevalence rate in adults is 5%, and the prevalence rate in adults aged 60 and over is 5.7%. According to the 2021 data from the US Centers for Disease Control and Prevention, compared to the general population, the rate of depression is 13.5% higher in older adults who need home healthcare services and 11.5% higher in hospitalized older adults. A recent systematic review and meta-analysis (2022) found that the global prevalence rate of depression in older adults was 28.4% and that the prevalence of depression in older adults is high, although there are variations by geographical location, diagnostic/screening tools, sample size, representativeness, and study quality. The isolation measures taken to prevent the spread of the COVID-19 pandemic have negative psychological effects on the protection of vulnerable groups, including older adults. Therefore, the pandemic is reported to have led to a significant increase in major depression cases globally, with an estimated 28.1% increase. With the COVID-19 pandemic, there is an increase in the demand for mental health services due to the increase in the incidence of depression and anxiety. Depression is more than a short-term emotional response to mood swings and psychological difficulties experienced in daily life. Especially recurrent and moderate or severe depression is an important health problem. The individual's daily life is negatively affected, functionality decreases and/or suicide may occur.
Depression is a serious mental disorder characterized by symptoms such as depressed mood or loss of interest/desire. In addition to these important symptoms, DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria include sleep problems, changes in appetite/weight, psychomotor restlessness/agitation, loss of energy, concentration problems, feelings of worthlessness or guilt, and recurrent suicidal thoughts. Over time, this illness leads to cognitive and social dysfunction.
In the treatment of depression, multimodal treatment options need to be carried out simultaneously. Although there are known effective treatments for mental disorders, more than 75% of people in low- and middle-income countries do not receive treatment. Barriers to effective care include a lack of financial resources, lack of legal regulations, lack of trained health professionals, and stigma. Therefore, psychotherapeutic interventions in inpatient/outpatient mental health facilities for psychosocial rehabilitation are insufficient, and effective care management is needed to address this problem.
In the treatment of depression, only medication can be used due to various factors such as patient preference and economic reasons. However, despite medication, the disability and decreased functionality seen in patients are not sufficient for the rehabilitation of the patient. Insight into the disease and low compliance with treatment emphasizes the need for psychotherapies and psychosocial interventions. In this sense, cognitive-behavioral therapy approaches and family interventions are an essential complement to psychopharmacology.
Metacognitive Training (MCT) was created by Steffen Moritz (2007) focusing on psychosis. Studies conducted using MCT show that MCT is beneficial in patients with schizophrenia and psychosis, reduces the severity of delusions, and shows a positive effect even after 6 months of follow-up. Following these results, Metacognitive Training for Depression (D-MCT), which focuses on cognitive biases specific to depression, was developed based on the Metacognitive Training for Psychosis program. Metacognitive Training for Depression is a new treatment option for depression and is a variant of cognitive behavioral therapy that adopts a metacognitive perspective by focusing on changing cognitive biases and dysfunctional attitudes. In the first pilot study conducted by Jelinek et al. (2013), it was proven that there was a significant decrease in depressive symptoms, cognitive distortions, and rumination and an increase in self-esteem. In other randomized controlled studies conducted by Jelinek and colleagues, at the end of Metacognitive Training for Depression and at 6-month follow-up, it was determined that there was more improvement in depressive symptoms and a decrease in dysfunctional metacognitive beliefs. In secondary analyses conducted 3.5 years later, it was found that positive effects were still seen in the groups where Metacognitive Training for Depression was applied. The adaptation study of the Metacognitive Training for Depression program to Turkish culture was conducted by Okyay and Taş (2017) and the results of the study show that there is a significant difference in the data of Rumi Positive \& Negative Scales, Ruminative Reactions Scale and Self-Efficacy Scale in depression patients who were administered this program. In another study (2022), after Metacognitive Training for Depression, there was a decrease in the Beck Depression Scale and Cognitive Distortions Scale scores, depression and cognitive distortion levels of patients.
The presentation of the positive effects of Metacognitive Training for Depression with high level of evidence has contributed to the development of the Metacognitive Training for Older Adults (MCT-Silver) program for depression in older adults. Metacognitive Training-Silver focuses on helping individuals move away from thought patterns that feed/support depression and focuses on physical changes that occur during the aging process, coping with loss and adapting to new social roles. Metacognitive Training-Silver addresses how to identify and reinterpret values in life for individuals aged 60 and over and how to move towards accepting situations that cannot be prevented/changed. In the first pilot study (2018) of the Metacognitive Training-Silver program, a significant reduction in depressive symptoms and dysfunctional attitudes was found. Therefore, more studies are needed to prove the effectiveness of the Metacognitive Training-Silver program.
The Metacognitive Training-Silver program has not yet been adapted to Turkish culture and studies are needed to prove its effectiveness in Turkey. In this direction, a randomized controlled trial is planned to evaluate the effectiveness of the Metacognitive Training-Silver program in older adults diagnosed with depression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Metacognitive Training-SilverParticipants in this group will have Metacognitive Training-Silver program. Metacognitive Training-Silver program is an eight-module training that focuses on common cognitive problems and dysfunctional attitudes, beliefs and prejudices in solving problems seen in depression. The purpose of the sessions is to convey information about false beliefs and cognitive distortions, and to help sick individuals think critically, convey their thoughts, and acquire new problem-solving strategies through exercises. |
| Control group | No intervention | –All participants in the control group will continue the treatment process determined in the routine. In this process, the patient participates in counseling and/or psychotherapy, ECT (electroconvulsive therapy) sessions, and psychopharmacological drugs. The control group will not participate in the Metacognitive Training-Silver program, an interview consisting of one session is planned considering for the placebo effect. At the end of the study, the Metacognitive Training-Silver program will be carried out with the voluntary participants in the control group, taking into account the ethics. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals aged 60 years and over,
- Diagnosis of depression by a psychiatrist according to DSM-V criteria,
- No change in psychopharmacological medications used within 3 months before the Metacognitive Training-Silver program,
- No psychiatric hospitalization in the last 3 months,
- No problems with vision, hearing, and understanding,
Key exclusion criteria (2 listed)
- Individuals under 60 years of age,
- Comorbid with a diagnosis of depression to the extent that it interferes with the understanding of the Metacognitive Training-Silver program;
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-SilverThe Metacognitive Training-Silver program includes the following topics: Thinking and Reasoning 1 (module 1), Memory (module 2), Thinking and Reasoning 2 (module 3), Self-Esteem (module 4), Thinking and Reasoning 3 (module 5), Behaviors and Strategies (module 6), Thinking and Reasoning 4 (module 7) and Perception of Feelings (module 8). Each session is planned to last 45-60 minutes. Materials will be used in the Metacognitive Training-Silver program are PPT (Power Point Presentations) slides, videos, homework exercises, and yellow-red cards. Metacognitive Training-Silver is planned to be applied face-to-face in 3 groups (12, 10, and 10 people) at scheduled times in a quiet room suitable for the group. In order to increase compliance with the Metacognitive Training-Silver program, the sessions will be applied during the routine treatment period. | Behavioural | Intervention Group |
Primary outcome
Beck's Depression Inventory (BDI): Time 1
Time frame: BDI will be applied on the first day of Metacognitive Training-Silver to both groups.
The purpose of the inventory, developed by Aaron T. Beck et al. in 1978, is to measure the severity and change of depressive symptoms in the individual. The Turkish validity and reliability study was carried out by Hisli Şahin. The scale provides a 4-point Likert-type measurement consisting of 21 items. In the scale, the individual is asked to indicate how he or she has felt in the last week. The high score obtained from the scale shows a high level of depression. (Hisli 1989a; Hisli 1989b). The BDI will be used at the beginning of the Metacognitive Training-Silver.
Beck's Depression Inventory (BDI): Time 2
Time frame: BDI will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.
The purpose of the inventory, developed by Aaron T. Beck et al. in 1978, is to measure the severity and change of depressive symptoms in the individual. The Turkish validity and reliability study was carried out by Hisli Şahin. The scale provides a 4-point Likert-type measurement consisting of 21 items. In the scale, the individual is asked to indicate how he or she has felt in the last week. The high score obtained from the scale shows a high level of depression. (Hisli 1989a; Hisli 1989b). The BDI will be used at the end of the Metacognitive Training-Silver.
Beck's Depression Inventory (BDI): Time 3
Time frame: BDI will be reapplied for a follow up evaluation, up to 3 months after the final program, in both groups.
The purpose of the inventory, developed by Aaron T. Beck et al. in 1978, is to measure the severity and change of depressive symptoms in the individual. The Turkish validity and reliability study was carried out by Hisli Şahin. The scale provides a 4-point Likert-type measurement consisting of 21 items. In the scale, the individual is asked to indicate how he or she has felt in the last week. The high score obtained from the scale shows a high level of depression. (Hisli 1989a; Hisli 1989b). The BDI will be used for follow-up evaluation up to 3 months after the final program.
Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 1
Time frame: DAS-R-TR will be applied on the first day of Metacognitive Training-Silver to both groups.
It was developed by Weissman and Beck (1987) as A and B forms, each consisting of 40 items, in order to detect intermediate beliefs that cause depression or anxiety in individuals and to learn their frequency (Weissman and Beck, 1978). However, the validity and reliability study of the revised and abbreviated version of the form was conducted by Batmaz and Özdel (2016) in order to be more useful for practitioners and those who filled out the scale. The scale, which consists of 13 items in the 7-Likert type, has two sub-dimensions as "Perfectionism/Achievement" (first 8 items) and "Need for Approval/Dependency" (last 5 items). If the total scores obtained are high, it indicates that individuals have more dysfunctional attitudes (Batmaz and Özdel, 2016). The DAS-R-TR will be used at the beginning of the Metacognitive Training-Silver.
Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 2
Time frame: DAS-R-TR will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.
It was developed by Weissman and Beck (1987) as A and B forms, each consisting of 40 items, in order to detect intermediate beliefs that cause depression or anxiety in individuals and to learn their frequency (Weissman and Beck, 1978). However, the validity and reliability study of the revised and abbreviated version of the form was conducted by Batmaz and Özdel (2016) in order to be more useful for practitioners and those who filled out the scale. The scale, which consists of 13 items in the 7-Likert type, has two sub-dimensions as "Perfectionism/Achievement" (first 8 items) and "Need for Approval/Dependency" (last 5 items). If the total scores obtained are high, it indicates that individuals have more dysfunctional attitudes (Batmaz and Özdel, 2016). The DAS-R-TR will be used at the end of the Metacognitive Training-Silver.
Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 3
Time frame: DAS-R-TR will be reapplied for a follow up evaluation, up to 3 months after the final program, in both groups.
It was developed by Weissman and Beck (1987) as A and B forms, each consisting of 40 items, in order to detect intermediate beliefs that cause depression or anxiety in individuals and to learn their frequency (Weissman and Beck, 1978). However, the validity and reliability study of the revised and abbreviated version of the form was conducted by Batmaz and Özdel (2016) in order to be more useful for practitioners and those who filled out the scale. The scale, which consists of 13 items in the 7-Likert type, has two sub-dimensions as "Perfectionism/Achievement" (first 8 items) and "Need for Approval/Dependency" (last 5 items). If the total scores obtained are high, it indicates that individuals have more dysfunctional attitudes (Batmaz and Özdel, 2016). The DAS-R-TR will be used for follow-up evaluation up to 3 months after the final program.
Metacognition Questionnaire-30 (MCQ-30): Time 1
Time frame: MCQ-30 will be applied on the first day of Metacognitive Training-Silver to both groups.
The MCQ-30 assesses individual differences in unhelpful metacognitions which may contribute to obsessive and compulsive symptoms, pathological worry, and underpin trait anxiety. The scale was developed based on the metacognitive model by Cartwright-Hatton \& Wells (65 items, 1997) and was shortened by Wells \& Cartwright-Hatton (30 items, 2004). The Turkish study was carried out by Yılmaz et al. and Tosun \& Irak in 2008 (Yılmaz et al., 2008; Tosun and Irak, 2008). According to the study of Tosun \& Irak (2008), a 4-point Likert-type scale consists five sub-dimensions: (Lack of) Cognitive Confidence, Positive Beliefs about Worry, Cognitive Self-Consciousness, Negative Beliefs about Uncontrollability and Danger, and Need to Control Thoughts. An increase in the score indicates an increase in pathological metacognitive activity (Tosun \& Irak, 2008). The MCQ-30 will be used at the beginning of the Metacognitive Training-Silver.
Metacognition Questionnaire-30 (MCQ-30): Time 2
Time frame: MCQ-30 will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.
The MCQ-30 assesses individual differences in unhelpful metacognitions which may contribute to obsessive and compulsive symptoms, pathological worry, and underpin trait anxiety. The scale was developed based on the metacognitive model by Cartwright-Hatton \& Wells (65 items, 1997) and was shortened by Wells \& Cartwright-Hatton (30 items, 2004). The Turkish study was carried out by Yılmaz et al. and Tosun \& Irak in 2008 (Yılmaz et al., 2008; Tosun and Irak, 2008). According to the study of Tosun \& Irak (2008), a 4-point Likert-type scale consists five sub-dimensions: (Lack of) Cognitive Confidence, Positive Beliefs about Worry, Cognitive Self-Consciousness, Negative Beliefs about Uncontrollability and Danger, and Need to Control Thoughts. An increase in the score indicates an increase in pathological metacognitive activity (Tosun \& Irak, 2008). The MCQ-30 will be used at the end of the Metacognitive Training-Silver.
Metacognition Questionnaire-30 (MCQ-30): Time 3
Time frame: MCQ-30 will be applied on the first day of Metacognitive Training-Silver to both groups.
The MCQ-30 assesses individual differences in unhelpful metacognitions which may contribute to obsessive and compulsive symptoms, pathological worry, and underpin trait anxiety. The scale was developed based on the metacognitive model by Cartwright-Hatton \& Wells (65 items, 1997) and was shortened by Wells \& Cartwright-Hatton (30 items, 2004). The Turkish study was carried out by Yılmaz et al. and Tosun \& Irak in 2008 (Yılmaz et al., 2008; Tosun and Irak, 2008). According to the study of Tosun \& Irak (2008), a 4-point Likert-type scale consists five sub-dimensions: (Lack of) Cognitive Confidence, Positive Beliefs about Worry, Cognitive Self-Consciousness, Negative Beliefs about Uncontrollability and Danger, and Need to Control Thoughts. An increase in the score indicates an increase in pathological metacognitive activity (Tosun \& Irak, 2008). The MCQ-30 will be used for follow-up evaluation up to 3 months after the final program.
The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 1
Time frame: EAAQ will be applied on the first day of Metacognitive Training-Silver to both groups.
The attitudes to ageing questionnaire was developed to provide a standard way of measuring attitudes to ageing from the perspective of older people. The scale was developed within the scope of a multi-center project supported by the EU 5th Framework Program to determine the perception level to aging of elderly. The Turkish adaptation and psychometric properties of the scale were studied by Eser et al. in 2011. The scale is a 5-point Likert-type scale consisting of three sub-dimensions (Psychosocial Loss; Physical Change and Psychological Growth) and a total of 24 items. As the total score of the scale increases, the attitude towards the related dimension also increases positively. (Eser et al. 2011). The EAAQ will be used at the beginning of the Metacognitive Training-Silver.
The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 2
Time frame: EAAQ will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.
The attitudes to ageing questionnaire was developed to provide a standard way of measuring attitudes to ageing from the perspective of older people. The scale was developed within the scope of a multi-center project supported by the EU 5th Framework Program to determine the perception level to aging of elderly. The Turkish adaptation and psychometric properties of the scale were studied by Eser et al. in 2011. The scale is a 5-point Likert-type scale consisting of three sub-dimensions (Psychosocial Loss; Physical Change and Psychological Growth) and a total of 24 items. As the total score of the scale increases, the attitude towards the related dimension also increases positively. (Eser et al. 2011). The EAAQ will be used at the end of the Metacognitive Training-Silver.
The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 3
Time frame: EAAQ will be applied on the first day of Metacognitive Training-Silver to both groups.
The attitudes to ageing questionnaire was developed to provide a standard way of measuring attitudes to ageing from the perspective of older people. The scale was developed within the scope of a multi-center project supported by the EU 5th Framework Program to determine the perception level to aging of elderly. The Turkish adaptation and psychometric properties of the scale were studied by Eser et al. in 2011. The scale is a 5-point Likert-type scale consisting of three sub-dimensions (Psychosocial Loss; Physical Change and Psychological Growth) and a total of 24 items. As the total score of the scale increases, the attitude towards the related dimension also increases positively. (Eser et al. 2011). The EAAQ will be used for follow-up evaluation up to 3 months after the final program.
1 secondary outcome
Personal Information Form (Sociodemographic Characteristics and Clinical Data)
Time frame: Personal Information Form will be applied on the first day of the first session of Metacognitive Training-Silver on both groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Background: PubMed 29693528Batmaz S, Ozdel K. Psychometric Properties of the Revised and Abbreviated form of the Turkish Version of the Dysfunctional Attitude Scale. Psychol Rep. 2016 Feb;118(1):180-198. doi: 10.1177/0033294116628349.
- Background: PubMed 34634250COVID-19 Mental Disorders Collaborators. Global prevalence and burden of depressive and anxiety disorders in 204 countries and territories in 2020 due to the COVID-19 pandemic. Lancet. 2021 Nov 6;398(10312):1700-1712. doi: 10.1016/S0140-6736(21)02143-7. Epub 2021 Oct 8.
- Background: PubMed 24497254Cuijpers P, Sijbrandij M, Koole SL, Andersson G, Beekman AT, Reynolds CF 3rd. Adding psychotherapy to antidepressant medication in depression and anxiety disorders: a meta-analysis. World Psychiatry. 2014 Feb;13(1):56-67. doi: 10.1002/wps.20089.
- Background: PubMed 29173244Evans-Lacko S, Aguilar-Gaxiola S, Al-Hamzawi A, Alonso J, Benjet C, Bruffaerts R, Chiu WT, Florescu S, de Girolamo G, Gureje O, Haro JM, He Y, Hu C, Karam EG, Kawakami N, Lee S, Lund C, Kovess-Masfety V, Levinson D, Navarro-Mateu F, Pennell BE, Sampson NA, Scott KM, Tachimori H, Ten Have M, Viana MC, Williams DR, Wojtyniak BJ, Zarkov Z, Kessler RC, Chatterji S, Thornicroft G. Socio-economic variations in the mental health treatment gap for people with anxiety, mood, and substance use disorders: results from the WHO World Mental Health (WMH) surveys. Psychol Med. 2018 Jul;48(9):1560-1571. doi: 10.1017/S0033291717003336. Epub 2017 Nov 27.
- Background: PubMed 35026139GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022 Feb;9(2):137-150. doi: 10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10.
- Background: PubMed 35316691Hu T, Zhao X, Wu M, Li Z, Luo L, Yang C, Yang F. Prevalence of depression in older adults: A systematic review and meta-analysis. Psychiatry Res. 2022 May;311:114511. doi: 10.1016/j.psychres.2022.114511. Epub 2022 Mar 16.
- Background: PubMed 32669358Islam N, Sharp SJ, Chowell G, Shabnam S, Kawachi I, Lacey B, Massaro JM, D'Agostino RB Sr, White M. Physical distancing interventions and incidence of coronavirus disease 2019: natural experiment in 149 countries. BMJ. 2020 Jul 15;370:m2743. doi: 10.1136/bmj.m2743.
- 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 28615651Jelinek L, Van Quaquebeke N, Moritz S. Cognitive and Metacognitive Mechanisms of Change in Metacognitive Training for Depression. Sci Rep. 2017 Jun 14;7(1):3449. doi: 10.1038/s41598-017-03626-8.
- Background: PubMed 30556583Jelinek L, Faissner M, Moritz S, Kriston L. Long-term efficacy of Metacognitive Training for Depression (D-MCT): A randomized controlled trial. Br J Clin Psychol. 2019 Sep;58(3):245-259. doi: 10.1111/bjc.12213. Epub 2018 Dec 16.
- Background: PubMed 29489070Liu YC, Tang CC, Hung TT, Tsai PC, Lin MF. The Efficacy of Metacognitive Training for Delusions in Patients With Schizophrenia: A Meta-Analysis of Randomized Controlled Trials Informs Evidence-Based Practice. Worldviews Evid Based Nurs. 2018 Apr;15(2):130-139. doi: 10.1111/wvn.12282. Epub 2018 Feb 28.
- Background: PubMed 17921766Moritz S, Woodward TS. Metacognitive training in schizophrenia: from basic research to knowledge translation and intervention. Curr Opin Psychiatry. 2007 Nov;20(6):619-25. doi: 10.1097/YCO.0b013e3282f0b8ed.
- Institute of Health Metrics and Evaluation, 2022, Global health data exchange resultsLink provided by the sponsor.
- World Health Organization, 2022, World Health Statistics 2022Link provided by the sponsor.
- World Health Organization, 2021, DepressionLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make IPD (Individual Participant Data) available. After the study is completed, the publication which includes the data results will be available.
Related trials for Depression in Old Age
RecruitingPhase 3
A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
Depressive Disorder, Major
RecruitingPhase 3
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Depressive Disorder, Major
Not yet recruiting
Cognitive Enhancement in Recurrent Depression (The COG-D-R Study)
Aging, Depression
Recruiting
Effectiveness of Health Communication on Depression Elderly in Ho Chi Minh City
Depression - Major Depressive Disorder
Active, not recruiting
Neurophysiological RCT of Qigong in Elderly With Depression
Depression
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.
Merve MURAT MEHMED ALİ, MSc, RN principal investigator
Istanbul University - Cerrahpasa
Sevim BUZLU, Prof, PhD, RN study chair
Istanbul University - Cerrahpasa
Lara Guedes de Pinho, Assoc Prof, PhD, RN study chair
University of Évora
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 in people with Depression in Old Age, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 26 Aug 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck's Depression Inventory (BDI): Time 1 (time frame: BDI will be applied on the first day of Metacognitive Training-Silver to both groups.). The study lists 12 primary outcomes in all. 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 NCT06042283, which also lists 30 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 26 Aug 2025.