- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03691428
Stress Reduction Study for Partners of Early Stage Dementia
February 13, 2024 updated by: Yale University
A Daily Self-Regulation Intervention for Persons With Early Stage Alzheimer's Disease and Related Dementias and Their Spouses
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Joan Monin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
|
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.
|
Other: Wait-list
Participants will get the WOOP training after the last outcome assessment.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Perceived Stress
Time Frame: baseline, 3 months
|
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.
|
baseline, 3 months
|
Change in Positive Affect
Time Frame: baseline, 3 months
|
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.
|
baseline, 3 months
|
Change in Depressive Symptoms
Time Frame: baseline, 3 months
|
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.
|
baseline, 3 months
|
Change in Quality of Life
Time Frame: baseline, 3 months
|
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.
|
baseline, 3 months
|
Change in Negative Emotions
Time Frame: baseline, 3 months
|
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.
|
baseline, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2019
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
June 21, 2018
First Submitted That Met QC Criteria
September 28, 2018
First Posted (Actual)
October 1, 2018
Study Record Updates
Last Update Posted (Actual)
February 15, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000021852
- R21AG055861-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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