Clinical trial NCT05640492: 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
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: University of Évora
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2022-12-07
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Hamilton Depression Rating Scale (HRSD-24)
timeFrame: Baseline
measure: Hamilton Depression Rating Scale (HRSD-24)
timeFrame: immediately after the intervention
measure: Hamilton Depression Rating Scale (HRSD-24)
timeFrame: Follow-up (6 months after the intervention)
Secondary outcomes:
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
measure: Beck-Depressions-Inventar II (BDI-II)
timeFrame: Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
measure: Mini Mental State Examination (MMSE)
timeFrame: Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
measure: Dysfunctional Attitudes Scale Form 18B (DAS-18B)
timeFrame: Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
measure: Metacognitions Questionnaire (MCQ-30)
timeFrame: Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
measure: Rosenberg Self-Esteem Scale
timeFrame: Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
measure: Ruminative Responses Scale
timeFrame: Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
measure: Attitudes to Ageing Questionnaire (AAQ)
timeFrame: Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
measure: ICF Core Set for Depression
timeFrame: Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
measure: World Health Organization Quality of Life-BREF - Item 1
timeFrame: Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)]
Other outcomes:
Locations:
city: Évora
country: Portugal
facility: Lara Manuela Guedes de Pinho
Study officials:
References: