Memory and Fear Study (Fear of Memory Loss Study)

NCT04821960 | Completed Results

• 1 other identifier: STU00214078
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety and Fear

Keywords

Mindfulness; Fear of memory loss

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  10 Weeks Post-Baseline

Secondary Outcomes (1)

• Memory Failure Scale (MFS)

  10 Week Post-Baseline

Study Arms (2)

Conventional Mindfulness Program

ACTIVE COMPARATOR

Routine mindfulness lessons and activities.

Behavioral: Conventional Mindfulness Program

Tailored Mindfulness Program for Fear of Memory Loss

EXPERIMENTAL

Tailored mindfulness lessons and activities for fear of memory loss.

Behavioral: Tailored Mindfulness Program for Fear of Memory Loss

Interventions

Tailored Mindfulness Program for Fear of Memory Loss BEHAVIORAL

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

Also known as: Conventional Mindfulness Program

Tailored Mindfulness Program for Fear of Memory Loss

Conventional Mindfulness Program BEHAVIORAL

Routine non-tailored mindfulness lessons and activities.

Conventional Mindfulness Program

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• 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.

  PMID: 38030988 DERIVED

• 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.

  PMID: 34328428 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: James W. Griffith
• Organization: Northwestern University

j-griffith@northwestern.edu

3125035345

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 30, 2021
• Study Start: May 17, 2021
• Primary Completion: June 29, 2022
• Study Completion: December 31, 2022
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)