Cognitive Control Mechanisms in Older Adults
ConditionDepressive Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHebrew University of Jerusalem
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Crossover
Treatments tested in this trial
GOLD-Cog+
Other intervention6 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 groups
42 Participants
are divided into 2 treatment groupsGroup A: GOLD-Cog+Experimental treatment 1 intervention
Group B: Waiting periodNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Pre-test, post-test (7-weeks after pre-test)2
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
Time frame
Pre-test, post-test (7-weeks after pre-test)Secondary outcomes
1
Beck Depression Scale (BDI-II)
Used to measure depressive symptomsThe BDI-II is a 21-item, self-administered questionnaire which requires 5-to-10-minutes to complete, aimed at measuring the severity of depression in diagnosed patients, as well as detecting possible depression in the normal population above the age of 13. Each question refers to the previous 2 weeks and is rated on a 4-point Likert scale, with scores ranging from 0 (absence of a given symptom) to 3 (maximum level of severity). Total scores range between 0-63 where a higher score indicates a higher severity of depression .
Time frame
Pre-test, post-test (7-weeks after pre-test)2
State Trait Anxiety Inventory (STAI) tool
Used to measure anxiety. It is a 20-item self-administered questionnaire regarding one's general feelings of anxiety at the present moment, using a 4-point Likert scale, with scores ranging from 1 (not at all) to 4 (very). Total scores range between 4-80 where a higher score indicates a higher level of anxiety.
Time frame
Pre-test, post-test (7-weeks after pre-test)3
The Older People's Quality of Life (OPQoL-35)
Used to measure quality of life. It is a 35-item self-administered questionnaire designed to capture the older adult's quality of life needs. Each question is scored on a 5-point Likert Scale, from 1 (strongly agree) to 5 (do not agree at all). Total scores range from 35 to 175, where a higher score indicates better quality of life.
Time frame
Pre-test, post-test (7-weeks after pre-test)Other outcomes
1
Cognitive Orientation to Occupational Performance (CO-OP) fidelity checklist
Used to ensure a high standard of procedural fidelity of the CO-OP intervention,
Time frame
Post-intervention (7-weeks after pre-test)2
Ruminative Response Scale (RRS-22)
Used to measure trait rumination. It is a 22-item, self-administered questionnaire regarding one's general way of thinking, using a 4-point Likert scale, from 1 (almost never) to 4 (almost always) with total scores range from 4-88, where a higher score indicates a higher level of rumination
Time frame
Pre-test, post-test (7-weeks after pre-test), follow-up (14 weeks after pre-test)3
Performance Quality Rating Scale (PQRS)
a 10-point scale used to measure daily functioning, by measuring occupational performance of client-selected activities. 1 means poor performance, with 10 meaning excellent performance
Time frame
Pre-test, post-test (7-weeks after pre-test), follow-up (14 weeks after pre-test)4
Intrinsic Motivation Inventory (IMI)
used to measure participants' subjective experience of their participation in the study
Time frame
Post-intervention (7-weeks after pre-test)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hebrew University of Jerusalem
Lead sponsor
University of Melbourne
Collaborator
Source ClinicalTrials.gov