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

August 8, 2023 updated by: Lara Manuela Guedes de Pinho, University of Évora

Metacognitive Training in the Older Adults With Depressive Symptoms

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Lara Pinho, PhD
  • Phone Number: 00351266740800
  • Email: lmgp@uevora.pt

Study Locations

  • Portugal
      • Évora, Portugal
        • Recruiting
        • Lara Manuela Guedes de Pinho
        • Contact:
          • Lara Pinho, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 105 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
Experimental: MCT Group
Older adults (more than 59 years old) with depressive symptoms
Behavioral: Metacognitive Training for Depression in Later Life (MCT-Silver)
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hamilton Depression Rating Scale (HRSD-24)
Time Frame: Baseline
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.
Baseline
Hamilton Depression Rating Scale (HRSD-24)
Time Frame: immediately after the intervention
The 24-item version of the Hamilton Depression Rating Scale is an established clinician-
immediately after the intervention
Hamilton Depression Rating Scale (HRSD-24)
Time Frame: Follow-up (6 months after the intervention)
The 24-item version of the Hamilton Depression Rating Scale is an established clinician-
Follow-up (6 months after the intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire 9 (PHQ-9)
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)]
9-item scale developed to assess depressive symptoms and to evaluate the symptoms of depression.
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Beck-Depressions-Inventar II (BDI-II)
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)]
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.
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Mini Mental State Examination (MMSE)
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)]
Developed by Folstein et al, 1975 to assess cognitive deficits.
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Dysfunctional Attitudes Scale Form 18B (DAS-18B)
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)]
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.
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Metacognitions Questionnaire (MCQ-30)
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)]
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.
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Rosenberg Self-Esteem Scale
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)]
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.
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Ruminative Responses Scale
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)]
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.
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Attitudes to Ageing Questionnaire (AAQ)
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)]
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.
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
ICF Core Set for 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)]
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.
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
World Health Organization Quality of Life-BREF - Item 1
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)]
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).
Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Évora

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GD/29805/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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