Clinical trial NCT06816797: Testing the Cog-Fun Aging Program for Older Adults With Subjective Cognitive Decline
Official title: Efficacy of the Cog-Fun Aging Health Promotion Intervention for Older Adults With Subjective Cognitive Decline: A Pilot Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subjective Cognitive Decline (SCD)
Subjective Cognitive Impairment
Subjective Memory Complaints
Keywords: negative self perceptions
cognitive mistakes
occupational experience
occupational therapy
subjective cognitive decline
health promotion intervention
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Israel
First posted: 2025-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be recruited from three centers. Each center will form a homogenous group for the Cog-Fun Aging intervention. One center will include both an intervention group and a control group with a crossover component.

At this center, participants in the intervention group will begin the 10-week Cog-Fun Aging program after an initial baseline assessment (T0). The control group will also be assessed at T0 but will not receive the intervention during this initial phase. Both groups will undergo a second assessment (T1) after the intervention group completes the program to evaluate changes. Following T1, the control group will participate in the intervention and undergo a final assessment (T2) to evaluate the effects of the intervention in the crossover phase. This design allows for comparison between the intervention and control groups, as well as evaluation of outcomes after the crossover phase.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn if the Cog-Fun Aging program helps older adults with Subjective Cognitive Decline (SCD) manage memory challenges and improve their daily lives. The main questions it aims to answer are:

* Does the program help participants better understand their cognitive challenges in daily life?
* Do participants report using more effective strategies to manage their memory difficulties?
* Does the Cog-Fun Aging program reduce negative emotions and self-perceptions related to SCD?

Researchers will compare participants who complete the Cog-Fun Aging program with those who do not to determine the program's effectiveness.

Participants will:

Take part in a 10-week program with weekly sessions. Learn about SCD and how it affects daily life. Practice and monitor strategies to manage memory difficulties.


Eligibility criteria: Inclusion Criteria:

* experiencing memory changes and feeling concerned about them
* a score of 23 or higher on the MoCA (Montreal Cognitive Assessment)
* ability to speak and understand Hebrew sufficiently to participate in a Hebrew-speaking group

Exclusion Criteria:

* a self-reported health condition that significantly impacts functioning (e.g., uncontrolled diabetes, severe heart/lung disease)
* residing in a medical institution or nursing home
* currently participating in another SCD treatment

Primary outcomes:
measure: Memory Impact Questionnaire (MIQ)
timeFrame: After enrollment (before intervention) and 10 weeks later (after intervention)
measure: Multifactorial Memory Questionnaire-Short Version (MMQ-9)
timeFrame: After enrollment (before intervention) and 10 weeks later (after intervention)
measure: Self-Regulation Skills Interview (SRSI) - adpated for study
timeFrame: After enrollment (before intervention) and 10 weeks later (after intervention)
measure: SCD Awareness of Cognitive Difficulties in Daily Life Interview (SCD Interview)
timeFrame: After enrollment (before intervention) and 10 weeks later (after intervention)
Secondary outcomes:
measure: Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
timeFrame: After enrollment (before intervention) and 10 weeks later (after intervention)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hebrew University of Jerusalem
city: Misgav
country: Israel
facility: Merhavim Misgav
city: Sde Warburg
country: Israel
facility: Hadarim College
Study officials:
affiliation: School of occupational therapy, faculty of medicine, Hebrew University
name: Adina Maeir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.
citation: Ownsworth TL, McFarland KM, Young RM. Development and standardization of the Self-regulation Skills Interview (SRSI): a new clinical assessment tool for acquired brain injury. Clin Neuropsychol. 2000 Feb;14(1):76-92. doi: 10.1076/1385-4046(200002)14:1;1-8;FT076.
citation: Troyer AK, Shaikh KT, Baptist-Mohseni N, Singh A, Duncan-Kofman J, Vandermorris S, Rich JB. Creation and Validation of the MMQ-9: A Short Version of the Multifactorial Memory Questionnaire for Middle-Aged and Older Adults. Clin Gerontol. 2025 May-Jun;48(3):528-538. doi: 10.1080/07317115.2024.2421876. Epub 2024 Oct 29.
citation: Shaikh KT, Tatham EL, Parikh PK, McCreath GA, Rich JB, Troyer AK. Development and Psychometric Validation of a Questionnaire Assessing the Impact of Memory Changes in Older Adults. Gerontologist. 2019 Jul 16;59(4):e248-e257. doi: 10.1093/geront/gny011.