Clinical trial NCT02319681: Reminiscence, Anxiety and Early Alzheimer's Disease
Official title: Reminiscence, Anxiety and Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Caregivers
Anxiety
Depression
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2014-12-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Acceptability of SR and AC
timeFrame: Week 20
Secondary outcomes:
measure: Number of times AC was used
timeFrame: Week 20
measure: Number of times SR was used
timeFrame: Week 20
measure: Change in Beck Depression Inventory-II (BDI-II) scale
timeFrame: Baseline, week 20
measure: Change in State-Trait Anxiety Inventory (STAI) scale
timeFrame: Baseline, week 20
measure: Change in Katz Instrumental Activities of Daily Living (IADL) scale
timeFrame: Baseline, week 20
measure: Change in Well-Being Picture Scale (WBPS) scale
timeFrame: Baseline, week 20
measure: Change in Short Psychological Well-Being Scale (SPWBS) scale
timeFrame: Baseline, week 20
measure: Change in Revised Memory and Behavior Problems Checklist (RMBPC) scale
timeFrame: Baseline, week 20
measure: Caregiver's mastery of SR intervention technique
timeFrame: Week 20
measure: Change in levels of cortisol
timeFrame: Baseline, Week 20
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Alzheimer's Disease Research Center
state: Georgia
Study officials:
affiliation: Emory University
name: William Puentes, PhD RN FAAN
role: PRINCIPAL_INVESTIGATOR
References: