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Metacognitive Training in the Older Adults With Depressive Symptoms (MCT-Silver)

Primary Purpose

Depressive Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Metacognitive Training for Depression in Later Life (MCT-Silver)
Sponsored by
University of Évora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms

Eligibility Criteria

60 Years - 105 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ability to give informed consent Age: 60 years or older Sufficient command of the Portuguese language Willingness to participate in the intervention for a period of 4 to 8 weeks (participants who do not participate in the intervention will also be included in the analysis) Adequate visual and hearing acuity for neuropsychological testing and participation in the group sessions Values above 10 on the Hamilton Depression Scale Exclusion Criteria: Active psychotic symptoms (i.e., hallucinations, delusions, or manias) Acute suicidal ideation Cognitive impairment Dementia or other neurological disease

Sites / Locations

  • Lara Manuela Guedes de PinhoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MCT Group

Control Group

Arm Description

Older adults (more than 59 years old) with depressive symptoms

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HRSD-24)
The 24-item version of the Hamilton Depression Rating Scale is an established clinician-rated assessment of depressive symptom severity and assesses psychological as well as somatic symptoms (scores range from 0-2 or 0-4) of depression. The clinician rates the severity of these symptoms based on the patient's report and his or her own observation. Scores range from 0-54. Based on the first 17 items, a score of 8-13 indicates mild depression, 14-18 indicates moderate depression, 19-22 indicates severe depression and scores greater than 23 indicate very severe depression. The scale has demonstrated good sensitivity and specificity among older adults (Mottram, Wilson & Copeland, 2001). The reliability and validity among older adult samples has also been confirmed (Korner et al., 2006). In terms of assessing change for the current trial, a greater reduction in depressive symptoms (i.e., change score) indicates better outcome.
Hamilton Depression Rating Scale (HRSD-24)
The 24-item version of the Hamilton Depression Rating Scale is an established clinician-
Hamilton Depression Rating Scale (HRSD-24)
The 24-item version of the Hamilton Depression Rating Scale is an established clinician-

Secondary Outcome Measures

Patient Health Questionnaire 9 (PHQ-9)
9-item scale developed to assess depressive symptoms and to evaluate the symptoms of depression.
Beck-Depressions-Inventar II (BDI-II)
Change in self-assessed depression as measured by the Beck Depression Inventory (BDI) total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The BDI is a 21-item self-report measure of depression symptoms. Total scores range from 0-63 with higher scores indicating more severe levels of depression.
Mini Mental State Examination (MMSE)
Developed by Folstein et al, 1975 to assess cognitive deficits.
Dysfunctional Attitudes Scale Form 18B (DAS-18B)
Change in dysfunctional attitudes as measured by change in the Dysfunctional Attitudes Scale Form 18B (DAS-18B) total score and subscale scores from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). Each item is endorsed on a 7-point scale (Range: 0-7) such that a total score of 126 is possible with higher scores indicating dysfunctional beliefs which are held more strongly. The total score is comprised of two subscales (perfectionism (Range 0-56); need for social approval (Range 0-21)), which are summed along with 7 other items to calculate the total scale score.
Metacognitions Questionnaire (MCQ-30)
Change in metacognitive beliefs as measured by change in the Metacognitions Questionnaire (MCQ-30) total score and subscale scores from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The 30-item scale has a range of 30-120. The scale is comprised of five subscales (range for each = 6-24): (1) Positive Beliefs (PB) about worry (6 items); (2) Negative Beliefs (NB) about thoughts concerning uncontrollability and danger (6 items), and (3) beliefs about the need to control thoughts (Need for Control [NFC],6 items); (4) Cognitive Confidence (6 items) and Cognitive Self-Consciousness (6 items). Higher scores indicate more strongly held metacognitive beliefs.
Rosenberg Self-Esteem Scale
Change in self-esteem as measured by change in the Rosenberg Self-Esteem scale total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The scale is comprised of 10 items and scores range from 10-40 with higher scores indicating higher self-esteem.
Ruminative Responses Scale
Change in rumination as measured by the Ruminative Responses Scale total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The scale is comprised of 10 items and scores range from 10-40 with higher scores indicating higher self-esteem.
Attitudes to Ageing Questionnaire (AAQ)
The attitudes to ageing questionnaire (AAQ) [12] was developed to provide a standard way of measuring attitudes to ageing from the perspective of older people.
ICF Core Set for Depression
was developed through the WHO International Classification of Functioning, Disability and Health (Cieza et al., 2004), and criteria are being developed to make the assessment more objective, through the modified e-Delphi technique.
World Health Organization Quality of Life-BREF - Item 1
Change in global quality of life as measured by change on item 1 on the World Health Organization Quality of Life-BREF from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). Responses on the item range from 1 (very bad quality of life) to 5 (very good quality of life).

Full Information

First Posted
October 6, 2022
Last Updated
August 8, 2023
Sponsor
University of Évora
Collaborators
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT05640492
Brief Title
Metacognitive Training in the Older Adults With Depressive Symptoms (MCT-Silver)
Official Title
Metacognitive Training in the Older Adults With Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Évora
Collaborators
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Depression is one of the most common mental disorders in older adults and a major cause of years lived with disability. Depression does not always respond to antidepressants, and non-pharmacological interventions are recommended by international guidelines. The Metacognitive Training for Depression in Later Life (MCT-Silver) is a creative and innovative group intervention that aims to reduce depressive symptoms by challenging the cognitive and metacognitive beliefs characteristic of this disorder, that intends to enable participants to recognize and correct their automatic and dysfunctional thinking patterns and behavior. It was developed by the partner institution's team, and has already demonstrated positive results. This project aims to extend the research study to Portugal, through cultural adaptation, pilot study, and a Randomized Controlled Trial (RCT). To this end, we defined the following aims: To plan and conduct a pilot study to assess the efficacy of the MCT-Silver in the Portuguese population; To conduct a multicenter randomized controlled trial (RCT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MCT Group
Arm Type
Experimental
Arm Description
Older adults (more than 59 years old) with depressive symptoms
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Metacognitive Training for Depression in Later Life (MCT-Silver)
Intervention Description
MCT-Silver consists of eight modules, each of which begins with psychoeducational and "normalizing" elements. A mastery is presented through examples and exercises, and the fallibility of human cognition is discussed and illustrated. In a second phase, the pathological extremes of each cognitive bias are highlighted and the participant is shown how the exacerbation of (normal) thinking biases can lead to problems in daily life. It is intended with this exercise that participants learn how to identify and mitigate cognitive "traps". Dysfunctional coping strategies (social isolation and negative thoughts) are highlighted, and suggestions for replacing them with adaptive strategies are given. Homework assignments are distributed at the end of each session (Schneider et al., 2018).
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HRSD-24)
Description
The 24-item version of the Hamilton Depression Rating Scale is an established clinician-rated assessment of depressive symptom severity and assesses psychological as well as somatic symptoms (scores range from 0-2 or 0-4) of depression. The clinician rates the severity of these symptoms based on the patient's report and his or her own observation. Scores range from 0-54. Based on the first 17 items, a score of 8-13 indicates mild depression, 14-18 indicates moderate depression, 19-22 indicates severe depression and scores greater than 23 indicate very severe depression. The scale has demonstrated good sensitivity and specificity among older adults (Mottram, Wilson & Copeland, 2001). The reliability and validity among older adult samples has also been confirmed (Korner et al., 2006). In terms of assessing change for the current trial, a greater reduction in depressive symptoms (i.e., change score) indicates better outcome.
Time Frame
Baseline
Title
Hamilton Depression Rating Scale (HRSD-24)
Description
The 24-item version of the Hamilton Depression Rating Scale is an established clinician-
Time Frame
immediately after the intervention
Title
Hamilton Depression Rating Scale (HRSD-24)
Description
The 24-item version of the Hamilton Depression Rating Scale is an established clinician-
Time Frame
Follow-up (6 months after the intervention)
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire 9 (PHQ-9)
Description
9-item scale developed to assess depressive symptoms and to evaluate the symptoms of depression.
Time Frame
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Title
Beck-Depressions-Inventar II (BDI-II)
Description
Change in self-assessed depression as measured by the Beck Depression Inventory (BDI) total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The BDI is a 21-item self-report measure of depression symptoms. Total scores range from 0-63 with higher scores indicating more severe levels of depression.
Time Frame
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Title
Mini Mental State Examination (MMSE)
Description
Developed by Folstein et al, 1975 to assess cognitive deficits.
Time Frame
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Title
Dysfunctional Attitudes Scale Form 18B (DAS-18B)
Description
Change in dysfunctional attitudes as measured by change in the Dysfunctional Attitudes Scale Form 18B (DAS-18B) total score and subscale scores from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). Each item is endorsed on a 7-point scale (Range: 0-7) such that a total score of 126 is possible with higher scores indicating dysfunctional beliefs which are held more strongly. The total score is comprised of two subscales (perfectionism (Range 0-56); need for social approval (Range 0-21)), which are summed along with 7 other items to calculate the total scale score.
Time Frame
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Title
Metacognitions Questionnaire (MCQ-30)
Description
Change in metacognitive beliefs as measured by change in the Metacognitions Questionnaire (MCQ-30) total score and subscale scores from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The 30-item scale has a range of 30-120. The scale is comprised of five subscales (range for each = 6-24): (1) Positive Beliefs (PB) about worry (6 items); (2) Negative Beliefs (NB) about thoughts concerning uncontrollability and danger (6 items), and (3) beliefs about the need to control thoughts (Need for Control [NFC],6 items); (4) Cognitive Confidence (6 items) and Cognitive Self-Consciousness (6 items). Higher scores indicate more strongly held metacognitive beliefs.
Time Frame
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Title
Rosenberg Self-Esteem Scale
Description
Change in self-esteem as measured by change in the Rosenberg Self-Esteem scale total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The scale is comprised of 10 items and scores range from 10-40 with higher scores indicating higher self-esteem.
Time Frame
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Title
Ruminative Responses Scale
Description
Change in rumination as measured by the Ruminative Responses Scale total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The scale is comprised of 10 items and scores range from 10-40 with higher scores indicating higher self-esteem.
Time Frame
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Title
Attitudes to Ageing Questionnaire (AAQ)
Description
The attitudes to ageing questionnaire (AAQ) [12] was developed to provide a standard way of measuring attitudes to ageing from the perspective of older people.
Time Frame
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Title
ICF Core Set for Depression
Description
was developed through the WHO International Classification of Functioning, Disability and Health (Cieza et al., 2004), and criteria are being developed to make the assessment more objective, through the modified e-Delphi technique.
Time Frame
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Title
World Health Organization Quality of Life-BREF - Item 1
Description
Change in global quality of life as measured by change on item 1 on the World Health Organization Quality of Life-BREF from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). Responses on the item range from 1 (very bad quality of life) to 5 (very good quality of life).
Time Frame
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to give informed consent Age: 60 years or older Sufficient command of the Portuguese language Willingness to participate in the intervention for a period of 4 to 8 weeks (participants who do not participate in the intervention will also be included in the analysis) Adequate visual and hearing acuity for neuropsychological testing and participation in the group sessions Values above 10 on the Hamilton Depression Scale Exclusion Criteria: Active psychotic symptoms (i.e., hallucinations, delusions, or manias) Acute suicidal ideation Cognitive impairment Dementia or other neurological disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lara Pinho, PhD
Phone
00351266740800
Email
lmgp@uevora.pt
Facility Information:
Facility Name
Lara Manuela Guedes de Pinho
City
Évora
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lara Pinho, PhD

12. IPD Sharing Statement

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Metacognitive Training in the Older Adults With Depressive Symptoms (MCT-Silver)

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