xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06042283</url>
    </required_header>
    <id_info>
      <org_study_id>01</org_study_id>
      <nct_id>NCT06042283</nct_id>
    </id_info>
    <brief_title>Efficacy of Metacognitive Training in Older Adults With Depression</brief_title>
    <official_title>Assessing the Efficacy of Metacognitive Training on Depressive Symptoms, Dysfunctional Attitudes and Metacognition in Older Adults Diagnosed With Depression</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul University - Cerrahpasa (IUC)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul University - Cerrahpasa (IUC)</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Effective pharmacological and psychological treatments for depression are available. However,&#xD;
        treatment modalities are not accessible to all patients diagnosed with depression.&#xD;
        Furthermore, some individuals who access treatment drop out and relapse after treatment.&#xD;
        Improving treatment modalities for depression is important given the rates of individuals&#xD;
        diagnosed worldwide, and rather than developing new treatments, there is a need to explore&#xD;
        how existing treatment modalities can be improved and implemented in a simpler and more&#xD;
        cost-effective way. To address this need, Metacognitive Training for Depression (DMCT) was&#xD;
        developed as a low-cost, easy-to-implement, cognitive behavioral therapy-based group&#xD;
        intervention. The aim of Metacognitive Training is to reduce depressive symptoms by working&#xD;
        with the patient's cognitive biases from a metacognitive perspective. The effectiveness of&#xD;
        this method, which has been proven effective by studies in the literature, is presented with&#xD;
        a pilot study on older adults in 2018. Since the studies evaluating the effectiveness of the&#xD;
        Metacognitive Training-Silver program are limited and it has not yet been adapted to Turkish&#xD;
        culture, this study aims to evaluate the effectiveness of the Metacognitive Training-Silver&#xD;
        program in older adults diagnosed with depression.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        According to the Global Burden of Disease (GBD-2019) report, mental disorders have been at&#xD;
        the top of the global burden of disease list between 1990 and 2019. Depression ranks first&#xD;
        among mental disorders with disability and psychosocial dependence (GBD 2019 Mental Disorders&#xD;
        Collaborators, 2022). The worldwide prevalence rate of depression is 3.8% and it is a common&#xD;
        disorder. The prevalence rate in adults is 5%, and the prevalence rate in adults aged 60 and&#xD;
        over is 5.7% (IHME, 2022). According to the 2021 data from the US Centers for Disease Control&#xD;
        and Prevention, compared to the general population, the rate of depression is 13.5% higher in&#xD;
        older adults who need home healthcare services and 11.5% higher in hospitalized older adults&#xD;
        (CDC, 2021). A recent systematic review and meta-analysis (2022) found that the global&#xD;
        prevalence rate of depression in older adults was 28.4% and that the prevalence of depression&#xD;
        in older adults is high, although there are variations by geographical location,&#xD;
        diagnostic/screening tools, sample size, representativeness, and study quality (Hu et al.,&#xD;
        2022). The isolation measures taken to prevent the spread of the COVID-19 pandemic have&#xD;
        negative psychological effects on the protection of vulnerable groups, including older adults&#xD;
        (Islam et al., 2020, Skoog, 2020). Therefore, the pandemic is reported to have led to a&#xD;
        significant increase in major depression cases globally, with an estimated 28.1% increase&#xD;
        (COVID-19 Mental Disorders Collaborators, 2021). With the COVID-19 pandemic, there is an&#xD;
        increase in the demand for mental health services due to the increase in the incidence of&#xD;
        depression and anxiety (World Health Statistics, 2022). Depression is more than a short-term&#xD;
        emotional response to mood swings and psychological difficulties experienced in daily life.&#xD;
        Especially recurrent and moderate or severe depression is an important health problem. The&#xD;
        individual's daily life is negatively affected, functionality decreases and/or suicide may&#xD;
        occur (WHO, 2022).&#xD;
  &#xD;
        Depression is a serious mental disorder characterized by symptoms such as depressed mood or&#xD;
        loss of interest/desire. In addition to these important symptoms, DSM-5 (Diagnostic and&#xD;
        Statistical Manual of Mental Disorders) criteria include sleep problems, changes in&#xD;
        appetite/weight, psychomotor restlessness/agitation, loss of energy, concentration problems,&#xD;
        feelings of worthlessness or guilt, and recurrent suicidal thoughts (APA, 2014). Over time,&#xD;
        this illness leads to cognitive and social dysfunction (Perini et al., 2019).&#xD;
  &#xD;
        In the treatment of depression, multimodal treatment options need to be carried out&#xD;
        simultaneously (Cuijpers et al., 2014). Although there are known effective treatments for&#xD;
        mental disorders, more than 75% of people in low- and middle-income countries do not receive&#xD;
        treatment (Evans-Lacko et al., 2018). Barriers to effective care include a lack of financial&#xD;
        resources, lack of legal regulations, lack of trained health professionals, and stigma (WHO,&#xD;
        2022; Scheiner et al., 2018). Therefore, psychotherapeutic interventions in&#xD;
        inpatient/outpatient mental health facilities for psychosocial rehabilitation are&#xD;
        insufficient, and effective care management is needed to address this problem.&#xD;
  &#xD;
        In the treatment of depression, only medication can be used due to various factors such as&#xD;
        patient preference and economic reasons. However, despite medication, the disability and&#xD;
        decreased functionality seen in patients are not sufficient for the rehabilitation of the&#xD;
        patient. Insight into the disease and low compliance with treatment emphasizes the need for&#xD;
        psychotherapies and psychosocial interventions. In this sense, cognitive-behavioral therapy&#xD;
        approaches and family interventions are an essential complement to psychopharmacology&#xD;
        (Cuijpers et al., 2014; Fansi et al., 2014) Metacognitive Training (MCT) was created by&#xD;
        Steffen Moritz (2007) focusing on psychosis (Moritz et al., 2007). Studies conducted using&#xD;
        MCT show that MCT is beneficial in patients with schizophrenia and psychosis, reduces the&#xD;
        severity of delusions, and shows a positive effect even after 6 months of follow-up (Liu, et&#xD;
        al., 2018; van Oosterhout et al., 2016). Following these results, Metacognitive Training for&#xD;
        Depression (D-MCT), which focuses on cognitive biases specific to depression, was developed&#xD;
        based on the Metacognitive Training for Psychosis program. Metacognitive Training for&#xD;
        Depression is a new treatment option for depression and is a variant of cognitive behavioral&#xD;
        therapy that adopts a metacognitive perspective by focusing on changing cognitive biases and&#xD;
        dysfunctional attitudes (Dietrichkeit et al., 2020). In the first pilot study conducted by&#xD;
        Jelinek et al. (2013), it was proven that there was a significant decrease in depressive&#xD;
        symptoms, cognitive distortions, and rumination and an increase in self-esteem (Jelinek et&#xD;
        al., 2013). In other randomized controlled studies conducted by Jelinek and colleagues, at&#xD;
        the end of Metacognitive Training for Depression and at 6-month follow-up, it was determined&#xD;
        that there was more improvement in depressive symptoms (Jelinek et al., 2016) and a decrease&#xD;
        in dysfunctional metacognitive beliefs (Jelinek et al., 2017). In secondary analyses&#xD;
        conducted 3.5 years later, it was found that positive effects were still seen in the groups&#xD;
        where Metacognitive Training for Depression was applied (Jelinek et al., 2019). The&#xD;
        adaptation study of the Metacognitive Training for Depression program to Turkish culture was&#xD;
        conducted by Okyay and Taş (2017) and the results of the study show that there is a&#xD;
        significant difference in the data of Rumi Positive &amp; Negative Scales, Ruminative Reactions&#xD;
        Scale and Self-Efficacy Scale in depression patients who were administered this program&#xD;
        (Okyay, 2017). In another study (2022), after Metacognitive Training for Depression, there&#xD;
        was a decrease in the Beck Depression Scale and Cognitive Distortions Scale scores,&#xD;
        depression and cognitive distortion levels of patients (Özgüç &amp; Tanrıverdi, 2022).&#xD;
  &#xD;
        The presentation of the positive effects of Metacognitive Training for Depression with high&#xD;
        level of evidence has contributed to the development of the Metacognitive Training for Older&#xD;
        Adults (MCT-Silver) program for depression in older adults. Metacognitive Training-Silver&#xD;
        focuses on helping individuals move away from thought patterns that feed/support depression&#xD;
        and focuses on physical changes that occur during the aging process, coping with loss and&#xD;
        adapting to new social roles. Metacognitive Training-Silver addresses how to identify and&#xD;
        reinterpret values in life for individuals aged 60 and over and how to move towards accepting&#xD;
        situations that cannot be prevented/changed. In the first pilot study (2018) of the&#xD;
        Metacognitive Training-Silver program, a significant reduction in depressive symptoms and&#xD;
        dysfunctional attitudes was found (Schneider et al., 2018). Therefore, more studies are&#xD;
        needed to prove the effectiveness of the Metacognitive Training-Silver program.&#xD;
  &#xD;
        The Metacognitive Training-Silver program has not yet been adapted to Turkish culture and&#xD;
        studies are needed to prove its effectiveness in Turkey. In this direction, a randomized&#xD;
        controlled trial is planned to evaluate the effectiveness of the Metacognitive&#xD;
        Training-Silver program in older adults diagnosed with depression.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Beck's Depression Inventory (BDI): Time 1</measure>
      <time_frame>BDI will be applied a week before Metacognitive Training-Silver to both groups.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Beck's Depression Inventory (BDI): Time 2</measure>
      <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.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Beck's Depression Inventory (BDI): Time 3</measure>
      <time_frame>BDI will be reapplied for a follow up evaluation, up to 3 months after the final program, in both groups.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 1</measure>
      <time_frame>DAS-R-TR will be applied a week before Metacognitive Training-Silver to both groups.</time_frame>
      <description>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 &quot;Perfectionism/Achievement&quot; (first 8 items) and &quot;Need for Approval/Dependency&quot; (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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 2</measure>
      <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.</time_frame>
      <description>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 &quot;Perfectionism/Achievement&quot; (first 8 items) and &quot;Need for Approval/Dependency&quot; (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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 3</measure>
      <time_frame>DAS-R-TR will be reapplied for a follow up evaluation, up to 3 months after the final program, in both groups.</time_frame>
      <description>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 &quot;Perfectionism/Achievement&quot; (first 8 items) and &quot;Need for Approval/Dependency&quot; (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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Metacognition Questionnaire-30 (MCQ-30): Time 1</measure>
      <time_frame>MCQ-30 will be applied a week before Metacognitive Training-Silver to both groups.</time_frame>
      <description>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 &amp; Wells (65 items, 1997) and was shortened by Wells &amp; Cartwright-Hatton (30 items, 2004). The Turkish study was carried out by Yılmaz et al. and Tosun &amp; Irak in 2008 (Yılmaz et al., 2008; Tosun and Irak, 2008). According to the study of Tosun &amp; 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 &amp; Irak, 2008). The MCQ-30 will be used at the beginning of the Metacognitive Training-Silver.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Metacognition Questionnaire-30 (MCQ-30): Time 2</measure>
      <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.</time_frame>
      <description>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 &amp; Wells (65 items, 1997) and was shortened by Wells &amp; Cartwright-Hatton (30 items, 2004). The Turkish study was carried out by Yılmaz et al. and Tosun &amp; Irak in 2008 (Yılmaz et al., 2008; Tosun and Irak, 2008). According to the study of Tosun &amp; 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 &amp; Irak, 2008). The MCQ-30 will be used at the end of the Metacognitive Training-Silver.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Metacognition Questionnaire-30 (MCQ-30): Time 3</measure>
      <time_frame>MCQ-30 will be applied a week before Metacognitive Training-Silver to both groups.</time_frame>
      <description>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 &amp; Wells (65 items, 1997) and was shortened by Wells &amp; Cartwright-Hatton (30 items, 2004). The Turkish study was carried out by Yılmaz et al. and Tosun &amp; Irak in 2008 (Yılmaz et al., 2008; Tosun and Irak, 2008). According to the study of Tosun &amp; 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 &amp; Irak, 2008). The MCQ-30 will be used for follow-up evaluation up to 3 months after the final program.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 1</measure>
      <time_frame>EAAQ will be applied a week before Metacognitive Training-Silver to both groups.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 2</measure>
      <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.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 3</measure>
      <time_frame>EAAQ will be applied a week before Metacognitive Training-Silver to both groups.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Personal Information Form (Sociodemographic Characteristics and Clinical Data)</measure>
      <time_frame>Personal Information Form will be applied a week before the first session of Metacognitive Training-Silver on both groups.</time_frame>
      <description>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 a week before the program to all participants and will be collected once.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Depression in Old Age</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Metacognitive Training-Silver</intervention_name>
      <description>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).&#xD;
  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.&#xD;
  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.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals aged 60 years and over,&#xD;
  &#xD;
            -  Diagnosis of depression by a psychiatrist according to DSM-V criteria,&#xD;
  &#xD;
            -  No change in psychopharmacological medications used within 3 months before the&#xD;
               Metacognitive Training-Silver program,&#xD;
  &#xD;
            -  No psychiatric hospitalization in the last 3 months,&#xD;
  &#xD;
            -  No problems with vision, hearing, and understanding,&#xD;
  &#xD;
            -  Being literate,&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals under 60 years of age,&#xD;
  &#xD;
            -  Comorbid with a diagnosis of depression to the extent that it interferes with the&#xD;
               understanding of the Metacognitive Training-Silver program;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Merve Murat, MSN,RN</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sevim Buzlu, Prof,PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Lara Guedes de Pinho, AsstProf,PhD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Évora</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Merve Murat, MSN,RN</last_name>
      <phone>+905074424196</phone>
      <email>merve.murat@ogr.iuc.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sevim Buzlu, Prof,PhD,RN</last_name>
      <phone>+905327934366</phone>
      <email>sevim.buzlu@iuc.edu.tr</email>
    </overall_contact_backup>
    <link>
      <url>http://ghdx.healthdata.org/gbd-results-tool?params=gbd-api-2019-permalink/d780dffbe8a381b25e1416884959e88b</url>
      <description>Institute of Health Metrics and Evaluation, 2022, Global health data exchange results</description>
    </link>
    <link>
      <url>https://www.who.int/news/item/20-05-2022-world-health-statistics-2022</url>
      <description>World Health Organization, 2022, World Health Statistics 2022</description>
    </link>
    <link>
      <url>https://www.who.int/news-room/fact-sheets/detail/depression</url>
      <description>World Health Organization, 2021, Depression</description>
    </link>
    <link>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
      <investigator_full_name>Lect. Merve MURAT, Ph.D.(c), MSN, RN</investigator_full_name>
      <investigator_title>Lecturer &amp; Ph.D. Student at Psychiatric Mental Health Nursing Department</investigator_title>
    </responsible_party>
    <keyword>geriatric depression</keyword>
    <keyword>psychotherapy</keyword>
    <keyword>metacognitive training-silver</keyword>
    <keyword>thought distortions</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>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.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06042283
  org study id: 01
  nct id: NCT06042283
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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 (GBD 2019 Mental Disorders
        Collaborators, 2022). 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% (IHME, 2022). 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
        (CDC, 2021). 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 (Hu et al.,
        2022). 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
        (Islam et al., 2020, Skoog, 2020). Therefore, the pandemic is reported to have led to a
        significant increase in major depression cases globally, with an estimated 28.1% increase
        (COVID-19 Mental Disorders Collaborators, 2021). 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 (World Health Statistics, 2022). 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 (WHO, 2022).
  
        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 (APA, 2014). Over time,
        this illness leads to cognitive and social dysfunction (Perini et al., 2019).
  
        In the treatment of depression, multimodal treatment options need to be carried out
        simultaneously (Cuijpers et al., 2014). Although there are known effective treatments for
        mental disorders, more than 75% of people in low- and middle-income countries do not receive
        treatment (Evans-Lacko et al., 2018). Barriers to effective care include a lack of financial
        resources, lack of legal regulations, lack of trained health professionals, and stigma (WHO,
        2022; Scheiner et al., 2018). 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
        (Cuijpers et al., 2014; Fansi et al., 2014) Metacognitive Training (MCT) was created by
        Steffen Moritz (2007) focusing on psychosis (Moritz et al., 2007). 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 (Liu, et
        al., 2018; van Oosterhout et al., 2016). 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 (Dietrichkeit et al., 2020). 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 (Jelinek et
        al., 2013). 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 (Jelinek et al., 2016) and a decrease
        in dysfunctional metacognitive beliefs (Jelinek et al., 2017). 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 (Jelinek et al., 2019). 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
        (Okyay, 2017). 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 (Özgüç & Tanrıverdi, 2022).
  
        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 (Schneider et al., 2018). 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Beck's Depression Inventory (BDI): Time 1
  time frame: BDI will be applied a week before Metacognitive Training-Silver to both groups.
  description: 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.
  measure: 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.
  description: 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.
  measure: 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.
  description: 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.
  measure: Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 1
  time frame: DAS-R-TR will be applied a week before Metacognitive Training-Silver to both groups.
  description: 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.
  measure: 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.
  description: 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.
  measure: 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.
  description: 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.
  measure: Metacognition Questionnaire-30 (MCQ-30): Time 1
  time frame: MCQ-30 will be applied a week before Metacognitive Training-Silver to both groups.
  description: 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.
  measure: 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.
  description: 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.
  measure: Metacognition Questionnaire-30 (MCQ-30): Time 3
  time frame: MCQ-30 will be applied a week before Metacognitive Training-Silver to both groups.
  description: 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.
  measure: The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 1
  time frame: EAAQ will be applied a week before Metacognitive Training-Silver to both groups.
  description: 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.
  measure: 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.
  description: 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.
  measure: The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 3
  time frame: EAAQ will be applied a week before Metacognitive Training-Silver to both groups.
  description: 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.
  measure: Personal Information Form (Sociodemographic Characteristics and Clinical Data)
  time frame: Personal Information Form will be applied a week before the first session of Metacognitive Training-Silver on both groups.
  description: 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 a week before the program to all participants and will be collected once.
  arm group label: Intervention Group
  arm group type: Experimental
  description: 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.
  arm group label: Control group
  arm group type: No Intervention
  description: 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.
  intervention type: Behavioral
  intervention name: Metacognitive Training-Silver
  description: 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.
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Merve Murat, MSN,RN
  role: Principal Investigator
  affiliation: Istanbul University - Cerrahpasa (IUC)
  last name: Sevim Buzlu, Prof,PhD
  role: Study Chair
  affiliation: Istanbul University - Cerrahpasa (IUC)
  last name: Lara Guedes de Pinho, AsstProf,PhD
  role: Study Chair
  affiliation: University of Évora
  last name: Merve Murat, MSN,RN
  phone: +905074424196
  email: merve.murat@ogr.iuc.edu.tr
  last name: Sevim Buzlu, Prof,PhD,RN
  phone: +905327934366
  email: sevim.buzlu@iuc.edu.tr
  url: http://ghdx.healthdata.org/gbd-results-tool?params=gbd-api-2019-permalink/d780dffbe8a381b25e1416884959e88b
  description: Institute of Health Metrics and Evaluation, 2022, Global health data exchange results
  url: https://www.who.int/news/item/20-05-2022-world-health-statistics-2022
  description: World Health Organization, 2022, World Health Statistics 2022
  url: https://www.who.int/news-room/fact-sheets/detail/depression
  description: World Health Organization, 2021, Depression
  url: https://www.cdc.gov/aging/depression/index.html#:~:text=The%20good%20news%20is%20that,11.5%25%20in%20older%20hospitalized%20patients
  description: Centers for Disease Control and Prevention (CDC), 2021, Depression is not a normal part of growing older
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  responsible party type: Principal Investigator
  investigator affiliation: Istanbul University - Cerrahpasa (IUC)
  investigator full name: Lect. Merve MURAT, Ph.D.(c), MSN, RN
  investigator title: Lecturer & Ph.D. Student at Psychiatric Mental Health Nursing Department
  mesh term: Depression
  mesh term: Depressive Disorder
  sharing ipd: No
  ipd description: 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.