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Subjective Cognitive Decline (SCD)NCT06816797

Testing the Cog-Fun Aging Program for Older Adults With Subjective Cognitive Decline

A study testing Cog Fun Ageing intervention and Cog-Fun Aging Crossover in people with Subjective Cognitive Decline (SCD) and Subjective Cognitive Impairment, run by Hebrew University of Jerusalem at 3 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Cog Fun Ageing intervention and Cog-Fun Aging Crossover
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
3 sitesIsrael
Study dates
20 Nov 2024to 24 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Israel3 sites

  • Hebrew University of Jerusalem

    Jerusalem, 9112102

  • Merhavim Misgav

    Misgav Regional Council

  • Hadarim College

    Sde Warburg

Other trials in Israel

About this study

Official title: Efficacy of the Cog-Fun Aging Health Promotion Intervention for Older Adults With Subjective Cognitive Decline: A Pilot Controlled Study

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?
Read more

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.

Being tested
Cog Fun Ageing intervention, Cog-Fun Aging Crossover
Keywords
negative self perceptions, cognitive mistakes, occupational experience, occupational therapy, subjective cognitive decline, health promotion intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cog Fun Ageing interventionOther

    Cog Fun Aging is a group-based intervention aimed at promoting positive occupational experiences despite cognitive challenges in day to day life. The intervention includes 10 weekly 120-minute group sessions led by experienced occupational therapists. Sessions incorporate learning about the bio-psycho-social factors of SCD and strategies to manage and cope with occupational challenges resulting from SCD.

  • Cog-Fun Aging CrossoverOther

    In the initial phase of the study (between T0 and T1) this group will receive "usual care". Participants are users of regional services where activities for healthy older adults are available. This group will continue going to activities as normal during the initial phase and then participate in the Cog-Fun Aging intervention.

Study groups in NCT06816797
Study groupRoleWhat they receive
Crossover control groupExperimentalParticipants in the control arm will not receive the Cog-Fun Aging intervention during the initial phase (10 weeks). Instead, they will undergo baseline assessments (T0) alongside the intervention group. After the first group completes the 10-week program, the control arm participants will be assessed again (T1). They will then begin the 10-week Cog-Fun Aging intervention and complete a final assessment (T2) after the intervention to evaluate its effects.
Receives: Other: Cog-Fun Aging Crossover
Cog-Fun aging interventionExperimentalNot described
Receives: Other: Cog Fun Ageing intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Memory Impact Questionnaire (MIQ)

    The questionnaire was developed for use in both clinical and research settings to better understand the impact of memory changes on the day-to-day functioning of older adults and to monitor outcomes of support programs for this population. In this study the new short form (27 items), not yet published, was used with permission by the authors of the MIQ. The questionnaire includes three subscales: Lifestyle Restrictions (social relationships, work, volunteer and leisure activities), Positive Coping (participation in cognitively engaging tasks and other positive responses to memory changes), and Negative Emotions (negative self-perceptions and perceived negative judgments from others). The total score reflects the overall burden of memory changes, with higher scores indicating with higher scores indicating a greater negative impact. The MIQ has psychometric support, including test-retest reliability (rs = .65-.91) and internal consistency (αs = .87-.93)

    Measured: After enrollment (before intervention) and 10 weeks later (after intervention)

  2. Multifactorial Memory Questionnaire-Short Version (MMQ-9)

    The short version is a 9 item questionnaire that assesses metamemory. It consists of three scales measuring satisfaction with one's memory (MMQ Satisfaction), self-perception of one's everyday memory abilities (MMQ-Ability), and use of practical memory strategies in day-to-day life (MMQ Strategy). Items are rated on a 5-point Likert scale. The MMQ-9 demonstrates strong psychometric properties, with Cronbach's alpha scores of 0.92 for Satisfaction, 0.86 for Ability, and 0.79 for Strategy, indicating high internal consistency, and intraclass correlation coefficients of 0.89, 0.84, and 0.78, respectively, showing good test-retest reliability. Convergent validity is supported by correlations with related measures (e.g., 0.74 for Satisfaction and 0.70 for Strategy), while discriminant validity is confirmed by negligible correlations with unrelated constructs (e.g., 0.08 for Satisfaction).

    Measured: After enrollment (before intervention) and 10 weeks later (after intervention)

  3. Self-Regulation Skills Interview (SRSI) - adpated for study

    Evaluates an individual's ability to articulate self-regulation and metacognitive skills in relation to daily life challenges. Includes 6 items that address key domains: emergent awareness, anticipatory awareness, readiness to change, strategy knowledge, strategy use, and strategy effectiveness. In this study, 5 of the 6 items will be utilized, excluding the readiness-to-change domain. Responses are scored on a 10-point scale, and scores are summarized and averaged into two main indices: awareness of difficulties and strategic behavior. Lower scores on these indices indicate stronger abilities in self-monitoring, recognizing, and anticipating difficulties, as well as identifying and effectively applying strategies to manage challenges. The tool demonstrates excellent psychometric properties, with interrater reliability ranging from 0.81 to 0.92 and test-retest reliability between 0.69 and 0.91.

    Measured: After enrollment (before intervention) and 10 weeks later (after intervention)

  4. SCD Awareness of Cognitive Difficulties in Daily Life Interview (SCD Interview)

    A made-for-study interview to assess participants' ability to describe detailed events in which they encountered cognitive challenges in everyday life and gauge their capacity to identify and articulate the thoughts and emotions that influenced their experiences, the contextual factors that supported or hindered cognitive functioning, the strategies they employed, and how they monitored those strategies' effectiveness in real-time during negative SCD-related daily experiences. Together, the SRSI and the SCD Interview) will provide a comprehensive understanding of participants' awareness of difficulties and strategy use, supporting the evaluation of intervention outcomes.

    Measured: After enrollment (before intervention) and 10 weeks later (after intervention)

Secondary outcomes (1)

  1. Patient Health Questionnaire for Depression and Anxiety (PHQ-4)

    A 4 item questionnaire that assesses emotional health. The tool combines the PHQ-2 for depression and the GAD-2 for anxiety, featuring a 4-point scale for responses, with total scores ranging from 0 to 12. Higher scores indicate more severe symptoms. The PHQ-4 has strong psychometric support, including internal reliability, construct validity, and factorial validity and criterion validity.

    Measured: After enrollment (before intervention) and 10 weeks later (after intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2025
  2. Study start20 Nov 2024
  3. Primary completion24 Jul 2025
  4. Study completion24 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Crossover
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.
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06816797
Sponsor's protocol ID
20112024
Status last verified
Feb 2025
First submitted
4 Feb 2025
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The study is still in its early stage a research program which aims to enhance the occupational experiences of individuals with Subjective Cognitive Decline (SCD) and identify or develop measures that effectively capture changes in occupational experiences following an intervention. At this stage, the investigators are still assessing whether the data collected by the current measures will adequately reflect the experiences the study seeks to understand and address.

Publications

  • 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.

    PubMed 19996233

  • 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.

    PubMed 10855062

  • 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.

    PubMed 39473141

  • 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.

    PubMed 29522122

Questions about this trial

What is this clinical trial studying?

A study testing Cog Fun Ageing intervention and Cog-Fun Aging Crossover in people with Subjective Cognitive Decline (SCD) and Subjective Cognitive Impairment, run by Hebrew University of Jerusalem at 3 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Memory Impact Questionnaire (MIQ) (time frame: After enrollment (before intervention) and 10 weeks later (after intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06816797, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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