Cognitive Control Mechanisms in Older Adults (GOLD-Cog+)

Hebrew University of Jerusalem

Status: Enrolling

Conditions: Depressive Symptoms

Treatments: Other: GOLD-Cog+

Study type: Interventional

Funder types: Other

Identifiers

NCT06631781

GOLD-Cog+

Details and patient eligibility

About

The prevalence of depressive symptoms in older adults is on the rise, affecting 13 to 37% of older adults globally. These symptoms significantly impact health, increasing the risk of dementia and cognitive decline, and impairing daily functioning and quality of life. Reduced cognitive control (CC) is a key factor contributing to depressive symptoms, affecting 40% of adults with such symptoms. Despite this, over half of affected adults do not respond well to available treatments. Computerized cognitive training (CCT) has shown efficacy in improving CC but its impact on daily functioning is limited. The Cognitive Orientation to Occupational Performance (CO-OP) approach has demonstrated promise in improving daily functioning, as measured by occupational performance (OP). We propose a novel intervention, GOLD-Cog+, combining CCT and CO-OP, to address CC and functional deficits in older adults with depressive symptoms.

Full description

The goal of this clinical trial is to investigate the relationship between mood and cognitive control in community-dwelling older adults (65+) with sub-clinical depression and to assess feasibility, efficacy, and sustainability of a proposed combined cognitive intervention, GOLD-Cog+, for this population group. Cognitive control is the mental abilities that underlie our goal-directed behavior. These mental abilities include: the ability to shift our attention, constantly monitoring and updating information provided by our environment and having the ability to inhibit unwanted reactions.

The main questions of this study are:

Question 1: What is the relationship between mood and cognitive control in daily life of older adults with depressive symptoms? Question 2: Can this proposed combined cognitive intervention, GOLD-Cog+ help improve daily functioning, cognitive control, mood, quality of life and subjective cognition in older adults with depressive symptoms? Question 3: Are the participants satisfied with this new proposed intervention?

Participants will participate in a crossover randomized control trial in which they will participate in a 6-week experimental period and a 6-week waiting period. During the experimental period, they will take part in individual computerized cognitive training and functional-based, goal-oriented group sessions.

Enrollment: 42 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Depressive Symptoms based on Patient Health Questionnaire (PHQ-8) ≥ 5
• Healthy Cognition based on Montreal Cognitive Assessment (MoCa) ≥ 20
• Capable of signing and agreeing to participate in the study
• Have the basic technological skills to use a tablet based on self-report
• Adequate sight and hearing abilities (with assistive technology) to be able to use a tablet and fully participate in a small group setting (6 people)
• Ability to fluently read, speak and understand Hebrew or English

Exclusion criteria

• Any neurodegenerative disorder (e.g., Mild Cognitive Impairment (MCI), Dementia, Parkinson's disease) via self-report
• Psychiatric disorders, not including depression or anxiety disorders (specifically: Schizophrenia, Bipolar or Psychotic disorders) via self-report

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

42 participants in 2 patient groups

GOLD-Cog+

Experimental group

Description:

The experimental group receives 6 weeks of combined cognitive intervention (GOLD-Cog+),which includes participation in 9, one hour long Cognitive-Orientation to Occupational Performance(CO-OP)-based group sessions and 24 individual and independent 30-minute computerized cognitive training (CCT) program using the Effectivate platform (Israeli-based CCT developed for older adults. Available in both Hebrew and English).

Treatment:

Other: GOLD-Cog+

Waiting period

No Intervention group

Description:

The same participants will also participate in 6-weeks of no intervention before or after the 6-week experimental period (i.e. crossover study). This will be used as the 'control' group.