Clinical trial NCT06042283: Efficacy of Metacognitive Training in Older Adults With Depression
Official title: Assessing the Efficacy of Metacognitive Training on Depressive Symptoms, Dysfunctional Attitudes and Metacognition in Older Adults Diagnosed With Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression in Old Age
Keywords: geriatric depression
psychotherapy
metacognitive training-silver
thought distortions
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Beck's Depression Inventory (BDI): Time 1
timeFrame: BDI will be applied on the first day of Metacognitive Training-Silver to both groups.
measure: Beck's Depression Inventory (BDI): Time 2
timeFrame: BDI will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.
measure: Beck's Depression Inventory (BDI): Time 3
timeFrame: BDI will be reapplied for a follow up evaluation, up to 3 months after the final program, in both groups.
measure: Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 1
timeFrame: DAS-R-TR will be applied on the first day of Metacognitive Training-Silver to both groups.
measure: Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 2
timeFrame: 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.
measure: Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 3
timeFrame: DAS-R-TR will be reapplied for a follow up evaluation, up to 3 months after the final program, in both groups.
measure: Metacognition Questionnaire-30 (MCQ-30): Time 1
timeFrame: MCQ-30 will be applied on the first day of Metacognitive Training-Silver to both groups.
measure: Metacognition Questionnaire-30 (MCQ-30): Time 2
timeFrame: 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.
measure: Metacognition Questionnaire-30 (MCQ-30): Time 3
timeFrame: MCQ-30 will be applied on the first day of Metacognitive Training-Silver to both groups.
measure: The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 1
timeFrame: EAAQ will be applied on the first day of Metacognitive Training-Silver to both groups.
measure: The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 2
timeFrame: EAAQ will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.
measure: The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 3
timeFrame: EAAQ will be applied on the first day of Metacognitive Training-Silver to both groups.
Secondary outcomes:
measure: Personal Information Form (Sociodemographic Characteristics and Clinical Data)
timeFrame: Personal Information Form will be applied on the first day of the first session of Metacognitive Training-Silver on both groups.
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Merve Murat, MSN,RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Sevim Buzlu, Prof,PhD
role: STUDY_CHAIR
affiliation: University of Évora
name: Lara Guedes de Pinho, AsstProf,PhD
role: STUDY_CHAIR
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