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

NCT05640492 | Unknown DMC

• 1 other identifier: GD/29805/2022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline

• Hamilton Depression Rating Scale (HRSD-24)

  The 24-item version of the Hamilton Depression Rating Scale is an established clinician-

  immediately after the intervention

• Hamilton Depression Rating Scale (HRSD-24)

  The 24-item version of the Hamilton Depression Rating Scale is an established clinician-

  Follow-up (6 months after the intervention)

Secondary Outcomes (10)

• Patient Health Questionnaire 9 (PHQ-9)

  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)

  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)

  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)

  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)

  Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]

Study Arms (2)

MCT Group

EXPERIMENTAL

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

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

Control Group

NO INTERVENTION

Interventions

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

MCT Group

Eligibility Criteria

• Age: 60 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active psychotic symptoms (i.e., hallucinations, delusions, or manias)
• Acute suicidal ideation
• Cognitive impairment
• Dementia or other neurological disease

Sponsors & Collaborators

• University of Évora: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (1)

Lara Manuela Guedes de Pinho

Evora, Portugal

RECRUITING

Related Publications (1)

• 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.

  PMID: 38022953 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Lara Pinho, PhD

CONTACT

00351266740800; lmgp@uevora.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: December 7, 2022
• Study Start: January 5, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2024
• Last Updated: August 9, 2023

Record last verified: 2023-08

Locations

PT (1)