Efficacy of Metacognitive Training in Older Adults With Depression

NCT ID: NCT06042283

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-10-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Metacognitive Training-Silver

Intervention Type: BEHAVIORAL

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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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;

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Lect. Merve MURAT MEHMED ALİ, Ph.D.(c), MSN, RN

Lecturer & Ph.D. Student at Psychiatric Mental Health Nursing Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Merve MURAT MEHMED ALİ, MSc, RN

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Sevim BUZLU, Prof, PhD, RN

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Lara Guedes de Pinho, Assoc Prof, PhD, RN

Role: STUDY_CHAIR

University of Évora

Locations

Istanbul University - Cerrahpaşa

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Related Links

http://ghdx.healthdata.org/gbd-results-tool?params=gbd-api-2019-permalink/d780dffbe8a381b25e1416884959e88b

Institute of Health Metrics and Evaluation, 2022, Global health data exchange results

https://www.who.int/news/item/20-05-2022-world-health-statistics-2022

World Health Organization, 2022, World Health Statistics 2022

https://www.who.int/news-room/fact-sheets/detail/depression

World Health Organization, 2021, Depression

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id