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

NCT ID: NCT05640492

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2024-12-31

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).

Conditions

Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MCT Group

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

Group Type: EXPERIMENTAL

Metacognitive Training for Depression in Later Life (MCT-Silver)

Intervention Type: BEHAVIORAL

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).

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

University of Évora

OTHER

Sponsor Role: lead

Responsible Party

Lara Manuela Guedes de Pinho

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lara Manuela Guedes de Pinho

Evora, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Lara Pinho, PhD

Role: CONTACT

lmgp@uevora.pt

00351266740800

Facility Contacts

Lara Pinho, PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 38022953 (View on PubMed)

Other Identifiers

GD/29805/2022

Identifier Type: -

Identifier Source: org_study_id