Depressive SymptomsNCT05640492
Metacognitive Training in the Older Adults With Depressive Symptoms (MCT-Silver)
A study testing Metacognitive Training for Depression in Later Life (MCT-Silver) in people with Depressive Symptoms, run by University of Évora at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 105 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Metacognitive Training for Depression in Later Life (MCT-Silver)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Jan 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active psychotic symptoms (i.e., hallucinations, delusions, or manias)
- Acute suicidal ideation
- Cognitive impairment
- Dementia or other neurological disease
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Lara Manuela Guedes de Pinho
Evora
Lara Pinho, PhD
About this study
Official title: 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).
- Conditions
- Depressive Symptoms
- Being tested
- Metacognitive Training for Depression in Later Life (MCT-Silver)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Training for Depression in Later Life (MCT-Silver)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| MCT Group | Experimental | Older adults (more than 59 years old) with depressive symptoms Receives: Behavioral: Metacognitive Training for Depression in Later Life (MCT-Silver) |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Hamilton Depression Rating Scale (HRSD-24)
The 24-item version of the Hamilton Depression Rating Scale is an established clinician-
Measured: immediately after the intervention
Hamilton Depression Rating Scale (HRSD-24)
The 24-item version of the Hamilton Depression Rating Scale is an established clinician-
Measured: Follow-up (6 months after the intervention)
Secondary outcomes (10)
Patient Health Questionnaire 9 (PHQ-9)
9-item scale developed to assess depressive symptoms and to evaluate the symptoms of depression.
Measured: 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)
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.
Measured: 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)
Developed by Folstein et al, 1975 to assess cognitive deficits.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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).
Measured: Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start5 Jan 2023
- Primary completionSep 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, Lara Manuela Guedes de Pinho, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640492
- Sponsor's protocol ID
- GD/29805/2022
- Status last verified
- Aug 2023
- First submitted
- 6 Oct 2022
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Pinho LG, Silva C, Fonseca C, Morgado B, Lopes M, Moritz S, Jelinek L, Schneider BC. A randomized controlled trial to evaluate the efficacy of metacognitive training for older adults with depression (MCT-Silver) in Portugal: study protocol. Front Psychol. 2023 Oct 31;14:1167860. doi: 10.3389/fpsyg.2023.1167860. eCollection 2023.
PubMed 38022953
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Training in the Older Adults With Depressive Symptoms
- ClinicalTrials.gov ID
- NCT05640492
- Acronym / sponsor ID
- GD/29805/2022
- Conditions
- Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCT Group | Experimental | Behavioral: Metacognitive Training for Depression in Later Life (MCT-Silver)Older adults (more than 59 years old) with depressive symptoms |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 60 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Active psychotic symptoms (i.e., hallucinations, delusions, or manias)
- Acute suicidal ideation
- Cognitive impairment
- Dementia or other neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | MCT Group |
Primary outcome
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.
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-
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-
10 secondary outcomes
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)]
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)]
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)]
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)]
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)]
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)]
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)]
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)]
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)]
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)]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Derived from this study: PubMed 38022953de Pinho LG, Silva C, Fonseca C, Morgado B, Lopes M, Moritz S, Jelinek L, Schneider BC. A randomized controlled trial to evaluate the efficacy of metacognitive training for older adults with depression (MCT-Silver) in Portugal: study protocol. Front Psychol. 2023 Oct 31;14:1167860. doi: 10.3389/fpsyg.2023.1167860. eCollection 2023.
Related trials for Depressive Symptoms
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Training for Depression in Later Life (MCT-Silver) in people with Depressive Symptoms, run by University of Évora at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lara Pinho, PhD (00351266740800, lmgp@uevora.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HRSD-24) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05640492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.