Memory and Fear Study (Fear of Memory Loss Study)

NCT ID: NCT04821960

Last Updated: 2024-05-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety and Fear

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional Mindfulness Program

Routine mindfulness lessons and activities.

Group Type ACTIVE_COMPARATOR

Conventional Mindfulness Program

Intervention Type BEHAVIORAL

Routine non-tailored mindfulness lessons and activities.

Tailored Mindfulness Program for Fear of Memory Loss

Tailored mindfulness lessons and activities for fear of memory loss.

Group Type EXPERIMENTAL

Tailored Mindfulness Program for Fear of Memory Loss

Intervention Type BEHAVIORAL

The tailored mindfulness program has been specifically created to focus on fear of memory loss compared to general mindfulness lessons and activities.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tailored Mindfulness Program for Fear of Memory Loss

The tailored mindfulness program has been specifically created to focus on fear of memory loss compared to general mindfulness lessons and activities.

Intervention Type BEHAVIORAL

Conventional Mindfulness Program

Routine non-tailored mindfulness lessons and activities.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Conventional Mindfulness Program

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

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

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwestern University

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38030988 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34328428 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU00214078

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Active Mind Study
NCT03289546 COMPLETED NA
Resilience and Brain Health of Older Adults (MEDEX-2)
NCT05124132 ENROLLING_BY_INVITATION NA