Efficacy of Metacognitive Training in Older Adults With Depression

Depression in Old Age Clinical Trial

Official title:

Assessing the Efficacy of Metacognitive Training on Depressive Symptoms, Dysfunctional Attitudes and Metacognition in Older Adults Diagnosed With Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06042283
• Other study ID #: 01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: September 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Merve Murat, MSN,RN
• Phone: +905074424196
• Email: merve.murat[@]ogr.iuc.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: March 1, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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,

Exclusion Criteria:

• 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;

Related Conditions & MeSH terms

• Depression
• Depression in Old Age
• Depressive Disorder

Intervention

Behavioral:
• Metacognitive Training-Silver
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

References & Publications (30)

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Jelinek L, Hauschildt M, Wittekind CE, Schneider BC, Kriston L, Moritz S. Efficacy of Metacognitive Training for Depression: A Randomized Controlled Trial. Psychother Psychosom. 2016;85(4):231-4. doi: 10.1159/000443699. Epub 2016 May 27. No abstract available. — View Citation

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Sahin. 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.	BDI will be applied on the first day of Metacognitive Training-Silver to both groups.
Primary	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 Sahin. 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.	BDI will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.
Primary	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 Sahin. 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.	BDI will be reapplied for a follow up evaluation, up to 3 months after the final program, in both groups.
Primary	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.	DAS-R-TR will be applied on the first day of Metacognitive Training-Silver to both groups.
Primary	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.	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.
Primary	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.	DAS-R-TR will be reapplied for a follow up evaluation, up to 3 months after the final program, in both groups.
Primary	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 Yilmaz et al. and Tosun & Irak in 2008 (Yilmaz 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.	MCQ-30 will be applied on the first day of Metacognitive Training-Silver to both groups.
Primary	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 Yilmaz et al. and Tosun & Irak in 2008 (Yilmaz 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.	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.
Primary	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 Yilmaz et al. and Tosun & Irak in 2008 (Yilmaz 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.	MCQ-30 will be applied on the first day of Metacognitive Training-Silver to both groups.
Primary	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.	EAAQ will be applied on the first day of Metacognitive Training-Silver to both groups.
Primary	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.	EAAQ will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.
Primary	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.	EAAQ will be applied on the first day of Metacognitive Training-Silver to both groups.
Secondary	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.	Personal Information Form will be applied on the first day of the first session of Metacognitive Training-Silver on both groups.

External Links

•   Centers for Disease Control and Prevention (CDC), 2021, Depression is not a normal part of growing older
•   Institute of Health Metrics and Evaluation, 2022, Global health data exchange results
•   World Health Organization, 2021, Depression
•   World Health Organization, 2022, World Health Statistics 2022