An interventional study of GOLD-Cog+ in Depressive Symptoms, sponsored by Hebrew University of Jerusalem. Recruiting at 1 site in Israel. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Hebrew University of Jerusalem · Not applicable, Interventional, and Treatment
Among 72 studies in Depression with a site in Israel — 8 open to participants now, 10 under way, none of them phase 3. Depression · Israel.
Among the 72 studies in Depression with a site in Israel, this one is the 41st largest by planned enrollment of the 56 interventional ones that give a count, is one of 2 that started in 2024, is one of 37 with no phase, and was the 65th registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
Browse Depression studies →8 of the 72 studies in Depression with a site in Israel are open now. Recruiting first, the newest first:
GrayMatters Health Ltd. · Sites in Israel, United States
Assaf-Harofeh Medical Center · Sites in Israel
Bar-Ilan University, Israel · Sites in Israel, United States
HaEmek Medical Center, Israel · Sites in Israel
University of Haifa · Sites in Israel
A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 65 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
72 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 9 · Phase 3 4 · Phase 4 6
First in 2003; this study’s year is marked. 2 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 42 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Median enrollment 60 across the 56 interventional studies, 200 across the 16 observational. Of the 31 that completed or were terminated, 1 (3%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 72 have an industry lead sponsor. The 10 most frequent:
Hebrew University of Jerusalem is the lead sponsor of 31 studies on the registry; 4 are open to participants now.
Hebrew University of Jerusalem has 3 studies filed under Depression — fewer than ten, so there is no comparison to draw.
2 of the studies in Depression with a site in Israel that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06982820GrayMatters Health Ltd.Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia | 2027-05-30 |
| NCT07913425University of HaifaExamining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents | 2027-06-30 |
Among the 72 studies in Depression with a site in Israel, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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+
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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Cognitive Failures Questionnaire (CFQ)
Used to measure subjective cognition. The CFQ will be used to measure subjective cognition. It is a 25-item questionnaire, with a scale of 0 to 4, where 4 is very often and 0 is never. Total score is out of 100.
Time frame: Pre-test, post-test (7-weeks after pre-test), follow-up (14 weeks after pre-test)
Satisfaction questionnaire and a semi-structured interview
Used to measure the participants' satisfaction with the study, specifically regarding the group meetings
Time frame: Post-intervention (7-weeks after pre-test)
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Dec 2024, 10 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 10 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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Hebrew University of Jerusalem