Reminiscence, Anxiety and Early Alzheimer's Disease

Not Applicable

Withdrawn

• Conditions: Alzheimer's Disease
• Interventions: Behavioral: Simple Reminiscence (SR); Behavioral: Attention Control (AC)

• Registration Number: NCT02319681
• Lead Sponsor: Emory University

Brief Summary

This study seeks to establish the acceptability and evaluate the limited efficacy of Simple Reminiscence (SR), a home-delivered non-pharmacological intervention designed to relieve stress, improve affect, and prevent or quell disruptive or maladaptive behaviors in community-residing individuals diagnosed with early Alzheimer's disease (EAD). Unmanaged episodes of anxiety can be antecedents of maladaptive behaviors, including agitation, anger, and sometimes even violence.

SR is a dyadic strategy; both the person with EAD and the caregiver engaged the patient's memory to interrupt a current episode of anxiety.

Detailed Description

Through the intervention, family caregivers are trained to collaborate with and guide patients to access positive memories as a way to manage or move past the anxiety that plagues individuals with EAD - often arising when confronted by common complex tasks they previously were able to perform.

During the project's first six months (phase 1), the investigators will develop a series of 4 video-vignettes illustrating dyads (including one member with EAD) managing a variety of anxiety provoking scenarios associated with EAD (e.g., trouble reconciling a checkbook) through the use of SR.

During the second phase of the project, a research assistant will administer SR at four home visits. The SR intervention has three components:

1. A didactic component using the SR manual that the couple retains (15 minutes);

2. Viewing one of the brief video-vignettes illustrating the application of reminiscence techniques (5 minutes; a different video-vignette will be viewed at each visit; and

3. Facilitation of caregiver practice in applying the techniques, using a recent example of anxiety-linked experience of the person with EAD (10 minutes). The caregiver is encouraged to learn and practice the techniques in order to cue and coach the person with EAD in their use.

The attention control treatment, a Social Visit, is a 30-minute activity in which the person with EAD, the caregiver and the research assistant (RA) review and discuss the day's newspaper headlines. The RA will use communication techniques specifically designed to keep the conversation present focused.

Both members of the dyad will collect saliva to evaluate diurnal cortisol secretion.

Study Timeline

• Study First Submitted: 2014-12-15
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-18
• Study Start: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Live in the community
• Reside with a primary caregiver who must be willing to participate in all study activities (the primary caregiver must have a familial or marital relationship with the person with EAD of sufficient length to support reminiscence activity [i.e., an adult child, a long-term spouse or committed partner])
• Have received a diagnosis of Early Alzheimer's Disease from a primary care provider
• Achieve a score on the mini-mental state examination (MMSE) between 19 and 25

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Exclusion Criteria

• Unable to give consent
• MMSE score lower than 19 or greater than 25.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simple Reminiscence (SR) caregiver	Simple Reminiscence (SR)	Subjects are caregivers for a persons with EAD and will be administered SR intervention and an attention control treatment four times
Simple Reminiscence (SR) EAD	Attention Control (AC)	Subjects are persons with EAD and will be administered SR intervention and an attention control treatment four times
Simple Reminiscence (SR) EAD	Simple Reminiscence (SR)	Subjects are persons with EAD and will be administered SR intervention and an attention control treatment four times
Simple Reminiscence (SR) caregiver	Attention Control (AC)	Subjects are caregivers for a persons with EAD and will be administered SR intervention and an attention control treatment four times

Primary Outcome Measures

Name	Time	Method
Acceptability of SR and AC	Week 20	Taped interview with the dyad will occur asking how acceptable the format, duration, and frequency of the program

Secondary Outcome Measures

Name	Time	Method
Number of times AC was used	Week 20	Taped interview with the dyad will occur asking how frequently AC was used
Number of times SR was used	Week 20	Taped interview with the dyad will occur asking how frequently SR was used
Change in Beck Depression Inventory-II (BDI-II) scale	Baseline, week 20	BDI-II is a 21-item, self-administered tool used to measure depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms.
Change in State-Trait Anxiety Inventory (STAI) scale	Baseline, week 20	STAI is a 20-item tool that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety.
Change in Katz Instrumental Activities of Daily Living (IADL) scale	Baseline, week 20	IADL is a six-item tool assessing the degree of independence vs. dependence in basic activities of daily living, with higher scores indicating greater levels of daily functioning.
Change in Well-Being Picture Scale (WBPS) scale	Baseline, week 20	WBPS is a 10-item non-language based pictorial scale that measures general well-being. Individuals are asked to mark the point along each scale to indicate which image they feel most like (drawings depicting a sense of high or low well-being are arranged at opposite ends of a scale).
Change in Short Psychological Well-Being Scale (SPWBS) scale	Baseline, week 20	SPWBS is a 84-item self-report, Likert-type inventory that measures well-being across six dimensions: Self-Acceptance, Positive Relations With Others, Autonomy, Environmental Mastery, Purpose in Life, and Personal Growth. A higher score indicated a greater sense of well-being.
Change in Revised Memory and Behavior Problems Checklist (RMBPC) scale	Baseline, week 20	RMBPC is a 24-item Likert-type caregiver-report measure of observable behavioral problems in dementia.
Caregiver's mastery of SR intervention technique	Week 20	Simple Reminiscence Intervention Mastery Assessment (SRIMA) evaluation rubric to be used to determine the person with EAD's and their caregiver's mastery of the SR Intervention techniques.
Change in levels of cortisol	Baseline, Week 20	Both members of the dyad will collect saliva to evaluate diurnal cortisol secretion by standard enzyme-linked immunoabsorbant assay ( ELISA).

Trial Locations

Locations (1)

Emory Alzheimer's Disease Research Center; 🇺🇸 Atlanta, Georgia, United States