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Stress Reduction Study for Partners of Early Stage Dementia

Primary Purpose

Dementia Caregiving

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wish Outcome Obstacle Plan
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dementia Caregiving

Eligibility Criteria

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

Inclusion/Exclusion Criteria:

  • The couple is married or in a cohabiting, committed relationship.
  • One partner has early Adult Dementia (AD) or a related dementia using criteria: symptoms consistent with early-stage dementia or memory impairment (e.g., AD, vascular dementia) and scores on the Neuropsychiatric Inventory (NPI) ≥3; Mini-Mental State Examination (MMSE) ≥18 and ≤27; and Barthel Index (BI) ≥5 and ≤1923. Or>20 on Telephone Interview for Cognitive Status. (TICS)
  • The spouse will have to score 27 or higher on the MMSE. Or>25 on TICS.
  • Both participants must agree to participate and complete baseline interviews.
  • Both partners are at least 60 years old.

Sites / Locations

  • Joan Monin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Wait-list

Arm Description

Participants will get the WOOP training after the last outcome assessment.

Outcomes

Primary Outcome Measures

Change in Perceived Stress
The Perceived Stress Scale (PSS-10) will be used to examine participants' stress over the past week. There are 10 items rated on a scale from 0 to 4. Greater scores indicate greater stress. Sum scores can range from 0 to 40 with 40 being the highest stress and 0 being the lowest.
Change in Positive Affect
Nine self-reported positive emotions (e.g., amusement, gratitude, hope) on a 1-5 scale over the past week using the Positive and Negative Affect Schedule (25 items). Higher scores indicate more positive emotions. Mean scores can range from 1 to 5 with 5 being the highest experience of positive emotions.
Change in Depressive Symptoms
10-item Center for Epidemiologic Studies of Depression Scale (CESD). Participants rate on a scale from 0 to 3. Higher numbers indicate more depressive symptoms. Sum scores can range from 0 to 30 with higher sums cores meaning more depressive symptoms.
Change in Quality of Life
Quality of life was measured with the Quality of Life in Alzheimer's Disease (QOL-AD). The QOL-AD consists of 13 items that capture multiple aspects of a person's quality of life in the context of dementia. It can also be used to examine the quality of life of family members of persons with dementia. Participants rate on a 5-point scale from poor to excellent the degree to which they feel about different aspects of their life (e.g. physical health, energy, mood, memory, family). Sum scores can range from 13 to 65 with higher scores meaning higher quality of life.
Change in Negative Emotions
Ten negative (e.g., irritable, distressed) adjectives were measured with the Positive and Negative Affect Scale. Each item has a score of 1 (not at all) to 5 (extremely). The mean of the 10 items will be measured. Mean scores can range from 1 to 5 with 5 meaning the highest experience of negative emotions.

Secondary Outcome Measures

Full Information

First Posted
June 21, 2018
Last Updated
February 7, 2022
Sponsor
Yale University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03691428
Brief Title
Stress Reduction Study for Partners of Early Stage Dementia
Official Title
A Daily Self-Regulation Intervention for Persons With Early Stage Alzheimer's Disease and Related Dementias and Their Spouses
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Aging (NIA)

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 is a study designed to pilot a WOOP (Wish Outcome Obstacle Plan) intervention for spouses of persons with early stage dementia for the purposes of future research. The investigators will be using two cohorts. One who will get the intervention and the other who will be wait listed and receive the intervention at a later date. Spouses of persons with dementia will use WOOP, a brief goal attainment sequence, every day for 16 days. Participants will complete surveys before the intervention, at Day 16, and at a 3-month follow-up. The outcome measures are goal attainment, emotion regulation skills, psychological health, and support quality. As of 9/2020 this entire study is being conducted remotely.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Caregiving

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Wait-list
Arm Type
Other
Arm Description
Participants will get the WOOP training after the last outcome assessment.
Intervention Type
Behavioral
Intervention Name(s)
Wish Outcome Obstacle Plan
Intervention Description
1. Wish or goal: A wish (e.g. "responding calmly when the partner asks a question repeatedly"). 2. Outcome: The most positive outcome of realizing the wish or goal (e.g. "both partners feel respected and happy"). Then the participant vividly imagines the outcome. 3. Obstacle: The most critical internal, controllable, obstacle (e.g., "feeling impatient"). Then the participant vividly imagines the internal obstacle occurring. 4. Plan: The participant answers the following question: What action can I take or what thought can I think to overcome the obstacle (e.g., "take a deep breath, take my partner's perspective, and answer the question calmly"); then he or she forms an "if" [specified obstacle - when I feel impatient], "then I will" [specified action or thought to overcome obstacle - take a deep breath, take my partner's perspective, and answer the question calmly] plan.
Primary Outcome Measure Information:
Title
Change in Perceived Stress
Description
The Perceived Stress Scale (PSS-10) will be used to examine participants' stress over the past week. There are 10 items rated on a scale from 0 to 4. Greater scores indicate greater stress. Sum scores can range from 0 to 40 with 40 being the highest stress and 0 being the lowest.
Time Frame
baseline, 3 months
Title
Change in Positive Affect
Description
Nine self-reported positive emotions (e.g., amusement, gratitude, hope) on a 1-5 scale over the past week using the Positive and Negative Affect Schedule (25 items). Higher scores indicate more positive emotions. Mean scores can range from 1 to 5 with 5 being the highest experience of positive emotions.
Time Frame
baseline, 3 months
Title
Change in Depressive Symptoms
Description
10-item Center for Epidemiologic Studies of Depression Scale (CESD). Participants rate on a scale from 0 to 3. Higher numbers indicate more depressive symptoms. Sum scores can range from 0 to 30 with higher sums cores meaning more depressive symptoms.
Time Frame
baseline, 3 months
Title
Change in Quality of Life
Description
Quality of life was measured with the Quality of Life in Alzheimer's Disease (QOL-AD). The QOL-AD consists of 13 items that capture multiple aspects of a person's quality of life in the context of dementia. It can also be used to examine the quality of life of family members of persons with dementia. Participants rate on a 5-point scale from poor to excellent the degree to which they feel about different aspects of their life (e.g. physical health, energy, mood, memory, family). Sum scores can range from 13 to 65 with higher scores meaning higher quality of life.
Time Frame
baseline, 3 months
Title
Change in Negative Emotions
Description
Ten negative (e.g., irritable, distressed) adjectives were measured with the Positive and Negative Affect Scale. Each item has a score of 1 (not at all) to 5 (extremely). The mean of the 10 items will be measured. Mean scores can range from 1 to 5 with 5 meaning the highest experience of negative emotions.
Time Frame
baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion/Exclusion Criteria: The couple is married or in a cohabiting, committed relationship. One partner has early Adult Dementia (AD) or a related dementia using criteria: symptoms consistent with early-stage dementia or memory impairment (e.g., AD, vascular dementia) and scores on the Neuropsychiatric Inventory (NPI) ≥3; Mini-Mental State Examination (MMSE) ≥18 and ≤27; and Barthel Index (BI) ≥5 and ≤1923. Or>20 on Telephone Interview for Cognitive Status. (TICS) The spouse will have to score 27 or higher on the MMSE. Or>25 on TICS. Both participants must agree to participate and complete baseline interviews. Both partners are at least 60 years old.
Facility Information:
Facility Name
Joan Monin
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34171086
Citation
Monin JK, Oettingen G, Laws H, David D, DeMatteo L, Marottoli R. A Controlled Pilot Study of the Wish Outcome Obstacle Plan Strategy for Spouses of Persons With Early-Stage Dementia. J Gerontol B Psychol Sci Soc Sci. 2022 Mar 3;77(3):513-524. doi: 10.1093/geronb/gbab115.
Results Reference
derived

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Stress Reduction Study for Partners of Early Stage Dementia

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