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Memory and Fear Study (Fear of Memory Loss Study)

Primary Purpose

Anxiety and Fear

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Mindfulness Program for Fear of Memory Loss
Conventional Mindfulness Program
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety and Fear focused on measuring Mindfulness, Fear of memory loss

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Mindfulness Program

Tailored Mindfulness Program for Fear of Memory Loss

Arm Description

Routine mindfulness lessons and activities.

Tailored mindfulness lessons and activities for fear of memory loss.

Outcomes

Primary Outcome Measures

Change of 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.
Change of 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.

Secondary Outcome Measures

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.
Patient Reported Outcome Measures Information System-29 (PROMIS-29)
A 29-item scale to assess quality of life, social functioning, fatigue, anxiety, and depression. Each item has 5 answer options (from 1 to 5). From the sum of the answers to each question in the domain, the total raw score for each domain is calculated, resulting in each domain score between 4 and 20.
World Health Organization Well-Being Index (WHO-5)
A 5-item scale to assess overall well-being. Minimum raw score = 0; maximum raw score = 25. Raw scores are multiplied by 4 to give a final score from 0 (representing the worst well-being) to 100 (representing the best well-being).
Patient Global Impression of Change (PGIC)
To assess participant's impression of change in their fear and anxiety since the start of the intervention. This scale is 1-item. Minimum score = 1; maximum score = 5. A higher score indicates the best change since starting the intervention.
Coronavirus Anxiety Scale (CAS)
A 5-item self-report mental health screener of dysfunctional anxiety associated with the coronavirus crisis. This scale is 5-items. Minimum score = 0; maximum score = 20. A higher score indicates higher dysfunctional coronavirus-related anxiety.

Full Information

First Posted
March 23, 2021
Last Updated
March 16, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04821960
Brief Title
Memory and Fear Study (Fear of Memory Loss Study)
Official Title
Improving Emotional Well-being and Quality of Life in Older Adults Experiencing Dementia-related Fear.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
June 29, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety and Fear
Keywords
Mindfulness, Fear of memory loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Mindfulness Program
Arm Type
Active Comparator
Arm Description
Routine mindfulness lessons and activities.
Arm Title
Tailored Mindfulness Program for Fear of Memory Loss
Arm Type
Experimental
Arm Description
Tailored mindfulness lessons and activities for fear of memory loss.
Intervention Type
Behavioral
Intervention Name(s)
Tailored Mindfulness Program for Fear of Memory Loss
Other Intervention Name(s)
Conventional Mindfulness Program
Intervention Description
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
Intervention Name(s)
Conventional Mindfulness Program
Intervention Description
Routine non-tailored mindfulness lessons and activities.
Primary Outcome Measure Information:
Title
Change of Fear and Avoidance of Memory Loss (FAM) Scale score at follow-up
Description
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.
Time Frame
10 Weeks Post-Baseline
Title
Change of Fear of Alzheimer's Disease Scale (FADS) score at follow-up
Description
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.
Time Frame
10 Weeks Post-Baseline
Secondary Outcome Measure Information:
Title
Memory Failure Scale (MFS)
Description
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.
Time Frame
10 Week Post-Baseline
Title
Patient Reported Outcome Measures Information System-29 (PROMIS-29)
Description
A 29-item scale to assess quality of life, social functioning, fatigue, anxiety, and depression. Each item has 5 answer options (from 1 to 5). From the sum of the answers to each question in the domain, the total raw score for each domain is calculated, resulting in each domain score between 4 and 20.
Time Frame
10 Weeks Post-Baseline
Title
World Health Organization Well-Being Index (WHO-5)
Description
A 5-item scale to assess overall well-being. Minimum raw score = 0; maximum raw score = 25. Raw scores are multiplied by 4 to give a final score from 0 (representing the worst well-being) to 100 (representing the best well-being).
Time Frame
10 Weeks Post-Baseline
Title
Patient Global Impression of Change (PGIC)
Description
To assess participant's impression of change in their fear and anxiety since the start of the intervention. This scale is 1-item. Minimum score = 1; maximum score = 5. A higher score indicates the best change since starting the intervention.
Time Frame
Follow-up (4 weeks)
Title
Coronavirus Anxiety Scale (CAS)
Description
A 5-item self-report mental health screener of dysfunctional anxiety associated with the coronavirus crisis. This scale is 5-items. Minimum score = 0; maximum score = 20. A higher score indicates higher dysfunctional coronavirus-related anxiety.
Time Frame
10 Weeks Post-Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified data may be shared with other researchers.
Citations:
PubMed Identifier
34328428
Citation
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.
Results Reference
derived

Learn more about this trial

Memory and Fear Study (Fear of Memory Loss Study)

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