Efficacy of Metacognitive Training in Older Adults With Depression

NCT06042283 | Completed DMC

• 1 other identifier: 01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression in Old Age

Keywords

geriatric depression; psychotherapy; metacognitive training-silver; thought distortions

Outcome Measures

Primary Outcomes (12)

• Beck's Depression Inventory (BDI): Time 1

  The purpose of the inventory, developed by Aaron T. Beck et al. in 1978, is to measure the severity and change of depressive symptoms in the individual. The Turkish validity and reliability study was carried out by Hisli Şahin. The scale provides a 4-point Likert-type measurement consisting of 21 items. In the scale, the individual is asked to indicate how he or she has felt in the last week. The high score obtained from the scale shows a high level of depression. (Hisli 1989a; Hisli 1989b). The BDI will be used at the beginning of the Metacognitive Training-Silver.

  BDI will be applied on the first day of Metacognitive Training-Silver to both groups.

• Beck's Depression Inventory (BDI): Time 2

  The purpose of the inventory, developed by Aaron T. Beck et al. in 1978, is to measure the severity and change of depressive symptoms in the individual. The Turkish validity and reliability study was carried out by Hisli Şahin. The scale provides a 4-point Likert-type measurement consisting of 21 items. In the scale, the individual is asked to indicate how he or she has felt in the last week. The high score obtained from the scale shows a high level of depression. (Hisli 1989a; Hisli 1989b). The BDI will be used at the end of the Metacognitive Training-Silver.

  BDI will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.

• Beck's Depression Inventory (BDI): Time 3

  The purpose of the inventory, developed by Aaron T. Beck et al. in 1978, is to measure the severity and change of depressive symptoms in the individual. The Turkish validity and reliability study was carried out by Hisli Şahin. The scale provides a 4-point Likert-type measurement consisting of 21 items. In the scale, the individual is asked to indicate how he or she has felt in the last week. The high score obtained from the scale shows a high level of depression. (Hisli 1989a; Hisli 1989b). The BDI will be used for follow-up evaluation up to 3 months after the final program.

  BDI will be reapplied for a follow up evaluation, up to 3 months after the final program, in both groups.

• Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 1

  It was developed by Weissman and Beck (1987) as A and B forms, each consisting of 40 items, in order to detect intermediate beliefs that cause depression or anxiety in individuals and to learn their frequency (Weissman and Beck, 1978). However, the validity and reliability study of the revised and abbreviated version of the form was conducted by Batmaz and Özdel (2016) in order to be more useful for practitioners and those who filled out the scale. The scale, which consists of 13 items in the 7-Likert type, has two sub-dimensions as "Perfectionism/Achievement" (first 8 items) and "Need for Approval/Dependency" (last 5 items). If the total scores obtained are high, it indicates that individuals have more dysfunctional attitudes (Batmaz and Özdel, 2016). The DAS-R-TR will be used at the beginning of the Metacognitive Training-Silver.

  DAS-R-TR will be applied on the first day of Metacognitive Training-Silver to both groups.

• Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 2

  It was developed by Weissman and Beck (1987) as A and B forms, each consisting of 40 items, in order to detect intermediate beliefs that cause depression or anxiety in individuals and to learn their frequency (Weissman and Beck, 1978). However, the validity and reliability study of the revised and abbreviated version of the form was conducted by Batmaz and Özdel (2016) in order to be more useful for practitioners and those who filled out the scale. The scale, which consists of 13 items in the 7-Likert type, has two sub-dimensions as "Perfectionism/Achievement" (first 8 items) and "Need for Approval/Dependency" (last 5 items). If the total scores obtained are high, it indicates that individuals have more dysfunctional attitudes (Batmaz and Özdel, 2016). The DAS-R-TR will be used at the end of the Metacognitive Training-Silver.

  DAS-R-TR will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.

• Dysfunctional Attitude Scale (Revised and Abbreviated Turkish Version- DAS-R-TR): Time 3

  It was developed by Weissman and Beck (1987) as A and B forms, each consisting of 40 items, in order to detect intermediate beliefs that cause depression or anxiety in individuals and to learn their frequency (Weissman and Beck, 1978). However, the validity and reliability study of the revised and abbreviated version of the form was conducted by Batmaz and Özdel (2016) in order to be more useful for practitioners and those who filled out the scale. The scale, which consists of 13 items in the 7-Likert type, has two sub-dimensions as "Perfectionism/Achievement" (first 8 items) and "Need for Approval/Dependency" (last 5 items). If the total scores obtained are high, it indicates that individuals have more dysfunctional attitudes (Batmaz and Özdel, 2016). The DAS-R-TR will be used for follow-up evaluation up to 3 months after the final program.

  DAS-R-TR will be reapplied for a follow up evaluation, up to 3 months after the final program, in both groups.

• Metacognition Questionnaire-30 (MCQ-30): Time 1

  The MCQ-30 assesses individual differences in unhelpful metacognitions which may contribute to obsessive and compulsive symptoms, pathological worry, and underpin trait anxiety. The scale was developed based on the metacognitive model by Cartwright-Hatton \& Wells (65 items, 1997) and was shortened by Wells \& Cartwright-Hatton (30 items, 2004). The Turkish study was carried out by Yılmaz et al. and Tosun \& Irak in 2008 (Yılmaz et al., 2008; Tosun and Irak, 2008). According to the study of Tosun \& Irak (2008), a 4-point Likert-type scale consists five sub-dimensions: (Lack of) Cognitive Confidence, Positive Beliefs about Worry, Cognitive Self-Consciousness, Negative Beliefs about Uncontrollability and Danger, and Need to Control Thoughts. An increase in the score indicates an increase in pathological metacognitive activity (Tosun \& Irak, 2008). The MCQ-30 will be used at the beginning of the Metacognitive Training-Silver.

  MCQ-30 will be applied on the first day of Metacognitive Training-Silver to both groups.

• Metacognition Questionnaire-30 (MCQ-30): Time 2

  The MCQ-30 assesses individual differences in unhelpful metacognitions which may contribute to obsessive and compulsive symptoms, pathological worry, and underpin trait anxiety. The scale was developed based on the metacognitive model by Cartwright-Hatton \& Wells (65 items, 1997) and was shortened by Wells \& Cartwright-Hatton (30 items, 2004). The Turkish study was carried out by Yılmaz et al. and Tosun \& Irak in 2008 (Yılmaz et al., 2008; Tosun and Irak, 2008). According to the study of Tosun \& Irak (2008), a 4-point Likert-type scale consists five sub-dimensions: (Lack of) Cognitive Confidence, Positive Beliefs about Worry, Cognitive Self-Consciousness, Negative Beliefs about Uncontrollability and Danger, and Need to Control Thoughts. An increase in the score indicates an increase in pathological metacognitive activity (Tosun \& Irak, 2008). The MCQ-30 will be used at the end of the Metacognitive Training-Silver.

  MCQ-30 will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.

• Metacognition Questionnaire-30 (MCQ-30): Time 3

  The MCQ-30 assesses individual differences in unhelpful metacognitions which may contribute to obsessive and compulsive symptoms, pathological worry, and underpin trait anxiety. The scale was developed based on the metacognitive model by Cartwright-Hatton \& Wells (65 items, 1997) and was shortened by Wells \& Cartwright-Hatton (30 items, 2004). The Turkish study was carried out by Yılmaz et al. and Tosun \& Irak in 2008 (Yılmaz et al., 2008; Tosun and Irak, 2008). According to the study of Tosun \& Irak (2008), a 4-point Likert-type scale consists five sub-dimensions: (Lack of) Cognitive Confidence, Positive Beliefs about Worry, Cognitive Self-Consciousness, Negative Beliefs about Uncontrollability and Danger, and Need to Control Thoughts. An increase in the score indicates an increase in pathological metacognitive activity (Tosun \& Irak, 2008). The MCQ-30 will be used for follow-up evaluation up to 3 months after the final program.

  MCQ-30 will be applied on the first day of Metacognitive Training-Silver to both groups.

• The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 1

  The attitudes to ageing questionnaire was developed to provide a standard way of measuring attitudes to ageing from the perspective of older people. The scale was developed within the scope of a multi-center project supported by the EU 5th Framework Program to determine the perception level to aging of elderly. The Turkish adaptation and psychometric properties of the scale were studied by Eser et al. in 2011. The scale is a 5-point Likert-type scale consisting of three sub-dimensions (Psychosocial Loss; Physical Change and Psychological Growth) and a total of 24 items. As the total score of the scale increases, the attitude towards the related dimension also increases positively. (Eser et al. 2011). The EAAQ will be used at the beginning of the Metacognitive Training-Silver.

  EAAQ will be applied on the first day of Metacognitive Training-Silver to both groups.

• The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 2

  The attitudes to ageing questionnaire was developed to provide a standard way of measuring attitudes to ageing from the perspective of older people. The scale was developed within the scope of a multi-center project supported by the EU 5th Framework Program to determine the perception level to aging of elderly. The Turkish adaptation and psychometric properties of the scale were studied by Eser et al. in 2011. The scale is a 5-point Likert-type scale consisting of three sub-dimensions (Psychosocial Loss; Physical Change and Psychological Growth) and a total of 24 items. As the total score of the scale increases, the attitude towards the related dimension also increases positively. (Eser et al. 2011). The EAAQ will be used at the end of the Metacognitive Training-Silver.

  EAAQ will be applied after the 8 sessions of Metacognitive Training-Silver completed to both groups. The training will be completed in 8 weeks.

• The WHO-Europe Attitudes of Aging Questionnaire (EAAQ): Time 3

  The attitudes to ageing questionnaire was developed to provide a standard way of measuring attitudes to ageing from the perspective of older people. The scale was developed within the scope of a multi-center project supported by the EU 5th Framework Program to determine the perception level to aging of elderly. The Turkish adaptation and psychometric properties of the scale were studied by Eser et al. in 2011. The scale is a 5-point Likert-type scale consisting of three sub-dimensions (Psychosocial Loss; Physical Change and Psychological Growth) and a total of 24 items. As the total score of the scale increases, the attitude towards the related dimension also increases positively. (Eser et al. 2011). The EAAQ will be used for follow-up evaluation up to 3 months after the final program.

  EAAQ will be applied on the first day of Metacognitive Training-Silver to both groups.

Secondary Outcomes (1)

• Personal Information Form (Sociodemographic Characteristics and Clinical Data)

  Personal Information Form will be applied on the first day of the first session of Metacognitive Training-Silver on both groups.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in this group will have Metacognitive Training-Silver program. Metacognitive Training-Silver program is an eight-module training that focuses on common cognitive problems and dysfunctional attitudes, beliefs and prejudices in solving problems seen in depression. The purpose of the sessions is to convey information about false beliefs and cognitive distortions, and to help sick individuals think critically, convey their thoughts, and acquire new problem-solving strategies through exercises.

Behavioral: Metacognitive Training-Silver

Control group

NO INTERVENTION

All participants in the control group will continue the treatment process determined in the routine. In this process, the patient participates in counseling and/or psychotherapy, ECT (electroconvulsive therapy) sessions, and psychopharmacological drugs. The control group will not participate in the Metacognitive Training-Silver program, an interview consisting of one session is planned considering for the placebo effect. At the end of the study, the Metacognitive Training-Silver program will be carried out with the voluntary participants in the control group, taking into account the ethics.

Interventions

Metacognitive Training-Silver 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.

Intervention Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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;

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University - Cerrahpaşa

Istanbul, Istanbul, 34381, Turkey (Türkiye)

Location

Related Publications (30)

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  BACKGROUND

Related Links

• Institute of Health Metrics and Evaluation, 2022, Global health data exchange results
• World Health Organization, 2022, World Health Statistics 2022
• World Health Organization, 2021, Depression

Study Officials

• Merve MURAT MEHMED ALİ, MSc, RN

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Sevim BUZLU, Prof, PhD, RN

  Istanbul University - Cerrahpasa

  STUDY CHAIR

• Lara Guedes de Pinho, Assoc Prof, PhD, RN

  University of Évora

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer & Ph.D. Student at Psychiatric Mental Health Nursing Department

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 18, 2023
• Study Start: September 15, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)