Dementia Caregiving
Conditions
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.
Interventions
BEHAVIORALWish Outcome Obstacle Plan
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.
Sponsors
National Institute on Aging (NIA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Stress | 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. |
| Change in Positive Affect | 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. |
| Change in Depressive Symptoms | 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. |
| Change in Quality of Life | 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. |
| Change in Negative Emotions | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Wish Outcome Obstacle Plan: 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. | 48 |
| Wait-list Participants will get the WOOP training after the last outcome assessment.
Wish Outcome Obstacle Plan: 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. | 42 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 6 | 8 |
Baseline characteristics
| Characteristic | Total | Intervention | Wait-list |
|---|---|---|---|
| Age, Continuous care partners | 74.0 years | 72.3 years | 76 years |
| Age, Continuous persons with dementia | 76.4 years | 75.8 years | 77.2 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 82 Participants | 43 Participants | 39 Participants |
| Region of Enrollment United States | 90 participants | 48 participants | 42 participants |
| Sex: Female, Male Female | 47 Participants | 25 Participants | 22 Participants |
| Sex: Female, Male Male | 43 Participants | 23 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 42 |
| other Total, other adverse events | 0 / 48 | 0 / 42 |
| serious Total, serious adverse events | 0 / 48 | 0 / 42 |
Outcome results
Primary
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.
Time frame: baseline, 3 months
Population: 20 caregivers in the intervention and 16 in the waitlist provided depression data at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Depressive Symptoms | 5.4 units on a scale | Standard Deviation 5.07 |
| Wait-list | Change in Depressive Symptoms | 9.75 units on a scale | Standard Deviation 6.45 |
p-value: <0.05Mixed Models Analysis
Primary
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.
Time frame: baseline, 3 months
Population: 21 care partners in the intervention and 17 in the waitlist reported negative emotions at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Negative Emotions | 1.8 score on a scale | Standard Deviation 0.54 |
| Wait-list | Change in Negative Emotions | 2.0 score on a scale | Standard Deviation 0.5 |
p-value: <0.05Mixed Models Analysis
Primary
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.
Time frame: baseline, 3 months
Population: 3 month follow-up data for perceived stress was only provided by 21 care partners in the intervention condition and 17 in the wait-list condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Perceived Stress | 13.6 score on a scale | Standard Deviation 6.3 |
| Wait-list | Change in Perceived Stress | 17.8 score on a scale | Standard Deviation 13.6 |
p-value: <0.05Mixed Models Analysis
Primary
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.
Time frame: baseline, 3 months
Population: 21 care partners in the intervention and 17 in the wait-list had positive emotion data at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Positive Affect | 3.60 score on a scale | Standard Deviation 0.61 |
| Wait-list | Change in Positive Affect | 3.20 score on a scale | Standard Deviation 0.87 |
p-value: <0.05Mixed Models Analysis
Primary
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.
Time frame: baseline, 3 months
Population: 21 care partners in the intervention and 17 in the waitlist group reported quality of life at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Quality of Life | 41.5 score on a scale | Standard Deviation 6.9 |
| Wait-list | Change in Quality of Life | 35.5 score on a scale | Standard Deviation 7 |
p-value: <0.05Mixed Models Analysis