Clinical trial NCT06631781: Cognitive Control Mechanisms in Older Adults
Official title: Cognitive Control Amongst Older Adults with Depressive Symptom: Mechanisms and Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
Collaborators: name: University of Melbourne
First posted: 2024-10-08
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will participate in both a 6-week experimental period and a 6-week waiting period
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adaptive Cognitive Evaluation (ACE) Battery
timeFrame: Pre-test, post-test (7-weeks after pre-test)
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Pre-test, post-test (7-weeks after pre-test)
Secondary outcomes:
measure: Beck Depression Scale (BDI-II)
timeFrame: Pre-test, post-test (7-weeks after pre-test)
measure: State Trait Anxiety Inventory (STAI) tool
timeFrame: Pre-test, post-test (7-weeks after pre-test)
measure: The Older People's Quality of Life (OPQoL-35)
timeFrame: Pre-test, post-test (7-weeks after pre-test)
Other outcomes:
measure: Cognitive Orientation to Occupational Performance (CO-OP) fidelity checklist
timeFrame: Post-intervention (7-weeks after pre-test)
measure: Ruminative Response Scale (RRS-22)
timeFrame: Pre-test, post-test (7-weeks after pre-test), follow-up (14 weeks after pre-test)
measure: Performance Quality Rating Scale (PQRS)
timeFrame: Pre-test, post-test (7-weeks after pre-test), follow-up (14 weeks after pre-test)
measure: Intrinsic Motivation Inventory (IMI)
timeFrame: Post-intervention (7-weeks after pre-test)
measure: Cognitive Failures Questionnaire (CFQ)
timeFrame: Pre-test, post-test (7-weeks after pre-test), follow-up (14 weeks after pre-test)
measure: Satisfaction questionnaire and a semi-structured interview
timeFrame: Post-intervention (7-weeks after pre-test)
Locations:
city: Jerusalem
country: Israel
facility: Computerized Neurotherapy Lab, School of OT, Hebrew University, Mt. Scopus Campus
Study officials:
References: