Cognitive Control Mechanisms in Older Adults

NCT06631781 | Recruiting

• 1 other identifier: GOLD-Cog+
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (2)

• Adaptive Cognitive Evaluation (ACE) Battery

  An online assessment tool, comprised of 6 sub-tasks based on standardized tests to assess cognitive control (inhibition, shifting, monitoring) in an immersive and user-friendly interface

  Pre-test, post-test (7-weeks after pre-test)

• Canadian Occupational Performance Measure (COPM)

  Used to measure functioning by measuring occupational performance. The COPM is a semi-structured interview rating clients' self-perception of performance and satisfaction in their five most important functional problems. Importance, performance, and satisfaction for each goal are rated on a 10-point Likert scale, with 1 denoting not important at all, not satisfied at all and not able to do it at all, and 10 denoting extremely important, able to do it extremely well and extremely satisfied, respective of the scale used

  Pre-test, post-test (7-weeks after pre-test)

Secondary Outcomes (3)

• Beck Depression Scale (BDI-II)

  Pre-test, post-test (7-weeks after pre-test)

• State Trait Anxiety Inventory (STAI) tool

  Pre-test, post-test (7-weeks after pre-test)

• The Older People's Quality of Life (OPQoL-35)

  Pre-test, post-test (7-weeks after pre-test)

Other Outcomes (6)

• Cognitive Orientation to Occupational Performance (CO-OP) fidelity checklist

  Post-intervention (7-weeks after pre-test)

• Ruminative Response Scale (RRS-22)

  Pre-test, post-test (7-weeks after pre-test), follow-up (14 weeks after pre-test)

• Performance Quality Rating Scale (PQRS)

  Pre-test, post-test (7-weeks after pre-test), follow-up (14 weeks after pre-test)

Study Arms (2)

GOLD-Cog+

EXPERIMENTAL

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).

Other: GOLD-Cog+

Waiting period

NO INTERVENTION

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.

Interventions

GOLD-Cog+ OTHER

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).

Also known as: CCT + functional-based approach (CO-OP)

GOLD-Cog+

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebrew University of Jerusalem: lead
• University of Melbourne: collaborator

Study Sites (1)

Computerized Neurotherapy Lab, School of OT, Hebrew University, Mt. Scopus Campus

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Eliane Gefen, MsC

CONTACT

0548075722; eliane.lavon@mail.huji.ac.il

Mor Nahum, Professor

CONTACT

mor.nahum@mail.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will participate in both a 6-week experimental period and a 6-week waiting period

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: October 8, 2024
• Study Start: February 2, 2024
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)