Subjective Cognitive Decline (SCD)NCT06632145
Cog-Fun Ageing Participation-centered, Health Promotion for Older Adults
A study testing Cog Fun Ageing intervention in people with Subjective Cognitive Decline (SCD), run by Hebrew University of Jerusalem at 1 site in Israel.
Trial summary
The goal of this feasibility study is to test the feasibility of a group intervention program based on health management principles for older adults with Subjective Cognitive Decline (SCD). SCD is a condition where individuals feel that their memory is worsening, although standard tests do not detect it. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Subjective Cognitive Decline (SCD)
- What is being tested?
- Cog Fun Ageing intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2024to 30 Jul 2024
- 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
- Self-reported memory changes,
- A score of 23 or higher on the Montreal Cognitive Assessment (MoCA)
- Proficiency in Hebrew to participate fully in a Hebrew-speaking group.
Who cannot join
- Presence of a significant health condition that affects functioning
- Residence in a medical institution or nursing home
- Current participation in another SCD treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cog-Fun Ageing Participation-centered, Health Promotion for Older Adult
The goal of this feasibility study is to test the feasibility of a group intervention program based on health management principles for older adults with Subjective Cognitive Decline (SCD). SCD is a condition where individuals feel that their memory is worsening, although standard tests do not detect it. This perceived memory decline can lead to negative feelings and self-perception, causing people to withdraw from meaningful activities.
This study aims to answer three main questions:
Read more
- Is the intervention feasible in terms of fidelity, adherence, and participant satisfaction?
- Are the assessments used sensitive enough to identify the unique challenges faced by the SCD population and detect changes after the intervention?
- What are the preliminary effects of the intervention on participants' perceptions of how SCD affects their daily life, mental health, and quality of life?
Participants will:
- Take part in 14 weekly group sessions focused on managing the challenges of living with SCD and improving participation in daily activities.
- Complete assessments before and after the intervention to measure their satisfaction with the program, and track changes in their perceptions of daily life, mental health, and quality of life.
- Conditions
- Subjective Cognitive Decline (SCD)
- Being tested
- Cog Fun Ageing intervention
- Keywords
- Occupational experience, Participation, Cognitive functional interventions, Functional decline
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 Ageing is a group-based occupation-centered intervention aimed at promoting positive occupational experiences despite cognitive challenges in day to day life. The intervention includes 14 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.
| Study group | Role | What they receive |
|---|---|---|
| Cog Fun Ageing intervention | Experimental | Not described Receives: Other: Cog Fun Ageing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory Impact Questionnaire (MIQ)
The Memory Impact Questionnaire (MIQ) will be used to assess the impact of perceived memory changes on daily life. 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. The questionnaire includes 51-item comprised of three subscales: Lifestyle Restrictions (19 items exploring social relationships, work, volunteer and leisure activities), Positive Coping (19 items exploring participation in cognitively engaging tasks and other positive responses to memory changes), and Negative Emotions (13 items exploring negative self-perceptions and perceived negative judgments from others). The total score, calculated by reverse-coding Positive Coping items and summing all items, reflects the overall burden of memory changes, with higher scores indicating a greater negative impact.
Measured: After enrollment (before intervention) and 14 weeks later (after intervention)
Secondary outcomes (3)
Patient Health Questionnaire -4 (PHQ-4 )
The Patient Health Questionnaire-4 (PHQ-4) is a brief, self-report screening tool designed to quickly assess symptoms of depression and anxiety in the general population. It includes four questions, with two focused on anxiety and two on depression. The PHQ-4 combines two well-established scales: the PHQ-2 (depression) and the GAD-2 (anxiety).
Participants respond to each question based on how often they have experienced certain symptoms over the past two weeks, using a 4-point Likert scale from 0 = Not at all to 3 = Nearly every day. The total score ranges from 0 to 12, with subscale scores ranging from 0 to 6 for both anxiety and depression. Scores are rated as: 0-2- Normal; 3-5 -Mild; 6-8- Moderate; 9-12- Severe.
Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.
Measured: After enrollment (before intervention) and 14 weeks later (after intervention)
SHARE version of the CASP-12
The CASP-12 (Control, Autonomy, Self-realization, and Pleasure) is a self-report questionnaire designed to measure the quality of life (QoL) in older adults, specifically targeting individuals aged 50 and over. The CASP-12 includes 12 items spread across four dimensions: control (the ability to influence one's environment), autonomy (freedom from external influence), self-realization (personal fulfillment), and pleasure (enjoyment in life).
Participants rate each item on a 4-point Likert scale, ranging from 1 (often) to 4 (never), with higher scores indicating a higher quality of life. The total score can range from 12 to 48, where higher scores suggest greater well-being and satisfaction in the participants' lives.
Measured: After enrollment (before intervention) and 14 weeks later (after intervention)
Engagement in Meaningful Activities Survey (EMAS)
The Engagement in Meaningful Activities Survey (EMAS) is a 12-item self-report questionnaire used to assess how meaningful a person's daily activities are. The survey asks participants to rate statements like "The activities I do give me a sense of satisfaction"; or "The activities I do help me feel competent," using a 4-point scale where 1 means "rarely"; and 4 means "always". The total score ranges from 12 to 48, with higher scores indicating higher levels of engagement in meaningful activities.
This tool is used to measure changes in how participants perceive the value and meaning of their activities. The EMAS helps identify whether interventions improve participants' sense of purpose and satisfaction in their daily lives.
Measured: After enrollment (before intervention) and 14 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.
- First posted8 Oct 2024
- Study start1 Apr 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive Decline (SCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre post pilot feasibility study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adina Maeir, Hebrew University of Jerusalem
- Investigators
- Adina Maeir, PhD, Principal investigator, School of occupational therapy, faculty of medicine, Hebrew University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632145
- Sponsor's protocol ID
- 04042023
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to the preliminary nature of the study, the outcome measures are still being evaluated for their suitability for interventions for the target population.
Publications
Roheger M, Hennersdorf XS, Riemann S, Floel A, Meinzer M. A systematic review and network meta-analysis of interventions for subjective cognitive decline. Alzheimers Dement (N Y). 2021 Jul 12;7(1):e12180. doi: 10.1002/trc2.12180. eCollection 2021.
PubMed 34268448Rotenberg S, Leung C, Quach H, Anderson ND, Dawson DR. Occupational performance issues in older adults with subjective cognitive decline. Disabil Rehabil. 2022 Aug;44(17):4681-4688. doi: 10.1080/09638288.2021.1916626. Epub 2021 May 14.
PubMed 33989108
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cog-Fun Ageing Participation-centered, Health Promotion for Older Adult
- ClinicalTrials.gov ID
- NCT06632145
- Acronym / sponsor ID
- 04042023
- Conditions
- Subjective Cognitive Decline (SCD)
- Keywords
- Occupational experience, Participation, Cognitive functional interventions, Functional decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this feasibility study is to test the feasibility of a group intervention program based on health management principles for older adults with Subjective Cognitive Decline (SCD). SCD is a condition where individuals feel that their memory is worsening, although standard tests do not detect it. This perceived memory decline can lead to negative feelings and self-perception, causing people to withdraw from meaningful activities.
This study aims to answer three main questions:
- Is the intervention feasible in terms of fidelity, adherence, and participant satisfaction?
- Are the assessments used sensitive enough to identify the unique challenges faced by the SCD population and detect changes after the intervention?
- What are the preliminary effects of the intervention on participants' perceptions of how SCD affects their daily life, mental health, and quality of life?
Participants will:
- Take part in 14 weekly group sessions focused on managing the challenges of living with SCD and improving participation in daily activities.
- Complete assessments before and after the intervention to measure their satisfaction with the program, and track changes in their perceptions of daily life, mental health, and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre post pilot feasibility study
| Arm | Type | Receives |
|---|---|---|
| Cog Fun Ageing intervention | Experimental | Other: Cog Fun Ageing intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-reported memory changes,
- A score of 23 or higher on the Montreal Cognitive Assessment (MoCA)
- Proficiency in Hebrew to participate fully in a Hebrew-speaking group.
Key exclusion criteria (3 listed)
- Presence of a significant health condition that affects functioning
- Residence in a medical institution or nursing home
- Current participation in another SCD treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cog Fun Ageing interventionCog Fun Ageing is a group-based occupation-centered intervention aimed at promoting positive occupational experiences despite cognitive challenges in day to day life. The intervention includes 14 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. | Other | Cog Fun Ageing intervention |
Primary outcome
Memory Impact Questionnaire (MIQ)
Time frame: After enrollment (before intervention) and 14 weeks later (after intervention)
The Memory Impact Questionnaire (MIQ) will be used to assess the impact of perceived memory changes on daily life. 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. The questionnaire includes 51-item comprised of three subscales: Lifestyle Restrictions (19 items exploring social relationships, work, volunteer and leisure activities), Positive Coping (19 items exploring participation in cognitively engaging tasks and other positive responses to memory changes), and Negative Emotions (13 items exploring negative self-perceptions and perceived negative judgments from others). The total score, calculated by reverse-coding Positive Coping items and summing all items, reflects the overall burden of memory changes, with higher scores indicating a greater negative impact.
3 secondary outcomes
Patient Health Questionnaire -4 (PHQ-4 )
Time frame: After enrollment (before intervention) and 14 weeks later (after intervention)
SHARE version of the CASP-12
Time frame: After enrollment (before intervention) and 14 weeks later (after intervention)
Engagement in Meaningful Activities Survey (EMAS)
Time frame: After enrollment (before intervention) and 14 weeks later (after intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 34268448Roheger M, Hennersdorf XS, Riemann S, Floel A, Meinzer M. A systematic review and network meta-analysis of interventions for subjective cognitive decline. Alzheimers Dement (N Y). 2021 Jul 12;7(1):e12180. doi: 10.1002/trc2.12180. eCollection 2021.
- Background: PubMed 33989108Rotenberg S, Leung C, Quach H, Anderson ND, Dawson DR. Occupational performance issues in older adults with subjective cognitive decline. Disabil Rehabil. 2022 Aug;44(17):4681-4688. doi: 10.1080/09638288.2021.1916626. Epub 2021 May 14.
- Individual participant dataSharing planned: Undecided. Due to the preliminary nature of the study, the outcome measures are still being evaluated for their suitability for interventions for the target population.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adina Maeir, PhD principal investigator
School of occupational therapy, faculty of medicine, Hebrew University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cog Fun Ageing intervention in people with Subjective Cognitive Decline (SCD), run by Hebrew University of Jerusalem at 1 site 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 21 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 1 site 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 14 weeks later (after intervention)). 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 NCT06632145, which also lists 2 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 21 Sep 2026.