Anxiety and FearNCT04821960

Memory and Fear Study (Fear of Memory Loss Study)

A study testing Tailored Mindfulness Program for Fear of Memory Loss and Conventional Mindfulness Program in people with Anxiety and Fear, run by Northwestern University at 1 site in United States.

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

This study is a randomized control study to determine the impact of a tailored, web-based mindfulness program to reduce anxiety and increase the quality of life in older adults experiencing dementia-related fears, relative to a conventional meditation program. Read more about this study

Who is it for?: Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for: Anxiety and Fear
What is being tested?: Tailored Mindfulness Program for Fear of Memory Loss and Conventional Mindfulness Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 1 siteUnited States
Study dates: 17 May 2021to 31 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

55 years of age or older
Elevated dementia-related fear
Able to read/write in English
Willingness to be randomized to intervention group
Willingness to complete three weeks of self-guided intervention, questionnaires, and cognitive tests.
Access to a reliable internet connection

Who cannot join

Diagnosis of mild cognitive impairment, Alzheimer's Disease, or dementia by a healthcare provider.
Impaired cognitive or neurologic function
Unstable medical condition
Severe depression
Current treatment for anxiety or depression
Current participation in another psychotherapy

Show all 9Show fewer

Current use of psychiatric medication
Current substance use disorder
Inadequate vision or hearing to interact with study materials

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Improving Emotional Well-being and Quality of Life in Older Adults Experiencing Dementia-related Fear.

Read the detailed description

The study will test two different types of online mindfulness programs to see if an online self-paced mindfulness program can help reduce anxiety related to memory loss. Participants will be involved in the study for a total of 10 weeks. Participants will log on to an online mindfulness program 4 days per week for about 10-20 minutes each. The total program will last 3 weeks. Participants will also be asked to complete questionnaires before starting the program, during the program, and after they complete the program.

Conditions: Anxiety and Fear
Being tested: Tailored Mindfulness Program for Fear of Memory Loss, Conventional Mindfulness Program
Keywords: Mindfulness, Fear of memory loss
Medical subject headings: Anxiety Disorders

What participants receive

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

Tailored Mindfulness Program for Fear of Memory LossBehavioural
Also called Conventional Mindfulness Program
The tailored mindfulness program has been specifically created to focus on fear of memory loss compared to general mindfulness lessons and activities.
Conventional Mindfulness ProgramBehavioural
Routine non-tailored mindfulness lessons and activities.

Study groups in NCT04821960
Study group	Role	What they receive
Conventional Mindfulness Program	Active comparator	Routine mindfulness lessons and activities. Receives: Behavioral: Conventional Mindfulness Program
Tailored Mindfulness Program for Fear of Memory Loss	Experimental	Tailored mindfulness lessons and activities for fear of memory loss. Receives: Behavioral: Tailored Mindfulness Program for Fear of Memory Loss

What is being measured

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

Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up
A 24-item scale to assess fear of memory loss. Scores range from 24-120 points with a higher score indicating a higher fear of memory loss.
Measured: 10 Weeks Post-Baseline
Fear of Alzheimer's Disease Scale (FADS) Score at Follow-up
A 30-item scale to assess fear of Alzheimer's disease. Minimum score = 0; maximum score = 120. A higher score indicates a greater fear of developing Alzheimer's Disease.
Measured: 10 Weeks Post-Baseline

Secondary outcomes (1)

Memory Failure Scale (MFS)
A 12-item scale that measures memory failure that people tend to experience in everyday life. Minimum score=12; maximum score= 60. A higher score indicates a greater likelihood of memory failures.
Measured: 10 Week Post-Baseline

Timeline

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

17 May 202131 Dec 2022

First posted30 Mar 2021
Study start17 May 2021
Primary completion29 Jun 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Anxiety and FearStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04821960
Sponsor's protocol ID: STU00214078
Status last verified: May 2024
First submitted: 23 Mar 2021
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: De-identified data may be shared with other researchers.

Publications

Farina FR, Regan J, Marquez M, An H, O'Loughlin P, Pavithra P, Taddeo M, Knight RC, Bennett M, Lenaert B, Griffith JW. Reducing fear and avoidance of memory loss improves mood and social engagement in community-based older adults: a randomized trial. BMC Geriatr. 2023 Nov 29;23(1):786. doi: 10.1186/s12877-023-04470-4.
PubMed 38030988
O'Loughlin P, Pavithra P, Regan J, Bennett M, Knight R, Lenaert B, Marquez M, Taddeo M, Griffith J, Shapiro R, Farina F. A Randomized Controlled Trial Investigating the Feasibility of a Low-Intensity Psychological Intervention for Fear of Memory Loss and Quality of Life in Older Adults: Protocol for the Reducing Fear and Avoidance of Memory Loss (REFRAME) Study. JMIR Res Protoc. 2021 Jul 30;10(7):e30514. doi: 10.2196/30514.
PubMed 34328428

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Emotional Well-being and Quality of Life in Older Adults Experiencing Dementia-related Fear.
ClinicalTrials.gov ID: NCT04821960
Acronym / sponsor ID: STU00214078
Conditions: Anxiety and Fear
Keywords: Mindfulness, Fear of memory loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: 17 May 2021 (actual)
Primary completion: 29 Jun 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 30 Mar 2021 (actual)
Results: Posted 16 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Conventional Mindfulness Program	Active comparator	Behavioral: Conventional Mindfulness ProgramRoutine mindfulness lessons and activities.
Tailored Mindfulness Program for Fear of Memory Loss	Experimental	Behavioral: Tailored Mindfulness Program for Fear of Memory LossTailored mindfulness lessons and activities for fear of memory loss.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

55 years of age or older
Elevated dementia-related fear
Able to read/write in English
Willingness to be randomized to intervention group
Willingness to complete three weeks of self-guided intervention, questionnaires, and cognitive tests.

Key exclusion criteria (9 listed)

Diagnosis of mild cognitive impairment, Alzheimer's Disease, or dementia by a healthcare provider.
Impaired cognitive or neurologic function
Unstable medical condition
Severe depression
Current treatment for anxiety or depression

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
Tailored Mindfulness Program for Fear of Memory LossAlso: Conventional Mindfulness ProgramThe tailored mindfulness program has been specifically created to focus on fear of memory loss compared to general mindfulness lessons and activities.	Behavioural	Tailored Mindfulness Program for Fear of Memory Loss
Conventional Mindfulness ProgramRoutine non-tailored mindfulness lessons and activities.	Behavioural	Conventional Mindfulness Program

Primary outcome

Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up
Time frame: 10 Weeks Post-Baseline
A 24-item scale to assess fear of memory loss. Scores range from 24-120 points with a higher score indicating a higher fear of memory loss.
Fear of Alzheimer's Disease Scale (FADS) Score at Follow-up
Time frame: 10 Weeks Post-Baseline
A 30-item scale to assess fear of Alzheimer's disease. Minimum score = 0; maximum score = 120. A higher score indicates a greater fear of developing Alzheimer's Disease.

1 secondary outcome

Memory Failure Scale (MFS)
Time frame: 10 Week Post-Baseline

Results and safety

Results posted to the registry on 16 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Conventional Mindfulness Program	41	36
Tailored Mindfulness Program for Fear of Memory Loss	40	30

Primary outcome: Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up

Time frame: 10 Weeks Post-Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Conventional Mindfulness Program n = 33	Tailored Mindfulness Program for Fear of Memory Loss n = 25
Value	63.9 (11.3)	60.3 (10.6)

Primary outcome: Fear of Alzheimer's Disease Scale (FADS) Score at Follow-up

Time frame: 10 Weeks Post-Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Conventional Mindfulness Program n = 40	Tailored Mindfulness Program for Fear of Memory Loss n = 33
Value	47.3 (20.7)	45.2 (20)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Data were collected over a 10 week period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Conventional Mindfulness Program	0 of 41 (0%)	0 of 41 (0%)	0 of 41
Tailored Mindfulness Program for Fear of Memory Loss	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38030988Farina FR, Regan J, Marquez M, An H, O'Loughlin P, Pavithra P, Taddeo M, Knight RC, Bennett M, Lenaert B, Griffith JW. Reducing fear and avoidance of memory loss improves mood and social engagement in community-based older adults: a randomized trial. BMC Geriatr. 2023 Nov 29;23(1):786. doi: 10.1186/s12877-023-04470-4.
Derived from this study: PubMed 34328428O'Loughlin P, Pavithra P, Regan J, Bennett M, Knight R, Lenaert B, Marquez M, Taddeo M, Griffith J, Shapiro R, Farina F. A Randomized Controlled Trial Investigating the Feasibility of a Low-Intensity Psychological Intervention for Fear of Memory Loss and Quality of Life in Older Adults: Protocol for the Reducing Fear and Avoidance of Memory Loss (REFRAME) Study. JMIR Res Protoc. 2021 Jul 30;10(7):e30514. doi: 10.2196/30514.
Individual participant dataSharing planned: No. De-identified data may be shared with other researchers.

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Active, not recruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tailored Mindfulness Program for Fear of Memory Loss and Conventional Mindfulness Program in people with Anxiety and Fear, run by Northwestern University at 1 site in United States.

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 6 inclusion and 9 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 16 May 2024. 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 United States. 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?

Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up (time frame: 10 Weeks Post-Baseline). The study lists 2 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 NCT04821960, 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 16 May 2024.