Trial Outcomes & Findings for Stress Reduction Study for Partners of Early Stage Dementia (NCT NCT03691428)
NCT ID: NCT03691428
Last Updated: 2024-02-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
baseline, 3 months
Results posted on
2024-02-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
42
|
|
Overall Study
COMPLETED
|
42
|
34
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
Baseline Characteristics
Ages of care partners and persons with dementia are presented individually.
Baseline characteristics by cohort
| Measure |
Intervention
n=48 Participants
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.
|
Wait-list
n=42 Participants
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.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
care partners
|
72.3 years
n=24 Participants • Ages of care partners and persons with dementia are presented individually.
|
76 years
n=21 Participants • Ages of care partners and persons with dementia are presented individually.
|
74.0 years
n=45 Participants • Ages of care partners and persons with dementia are presented individually.
|
|
Age, Continuous
persons with dementia
|
75.8 years
n=24 Participants • Ages of care partners and persons with dementia are presented individually.
|
77.2 years
n=21 Participants • Ages of care partners and persons with dementia are presented individually.
|
76.4 years
n=45 Participants • Ages of care partners and persons with dementia are presented individually.
|
|
Sex: Female, Male
Female
|
25 Participants
n=48 Participants
|
22 Participants
n=42 Participants
|
47 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=48 Participants
|
20 Participants
n=42 Participants
|
43 Participants
n=90 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=48 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=48 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=48 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=48 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=90 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=48 Participants
|
39 Participants
n=42 Participants
|
82 Participants
n=90 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=48 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=48 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=90 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=48 Participants
|
42 participants
n=42 Participants
|
90 participants
n=90 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=21 Participants
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.
|
Wait-list
n=17 Participants
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.
|
|---|---|---|
|
Change in Perceived Stress
|
13.6 score on a scale
Standard Deviation 6.3
|
17.8 score on a scale
Standard Deviation 13.6
|
PRIMARY outcome
Timeframe: baseline, 3 monthsPopulation: 21 care partners in the intervention and 17 in the wait-list had positive emotion data at 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.
Outcome measures
| Measure |
Intervention
n=21 Participants
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.
|
Wait-list
n=17 Participants
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.
|
|---|---|---|
|
Change in Positive Affect
|
3.60 score on a scale
Standard Deviation .61
|
3.20 score on a scale
Standard Deviation .87
|
PRIMARY outcome
Timeframe: baseline, 3 monthsPopulation: 20 caregivers in the intervention and 16 in the waitlist provided depression data at 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.
Outcome measures
| Measure |
Intervention
n=20 Participants
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.
|
Wait-list
n=16 Participants
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.
|
|---|---|---|
|
Change in Depressive Symptoms
|
5.4 units on a scale
Standard Deviation 5.07
|
9.75 units on a scale
Standard Deviation 6.45
|
PRIMARY outcome
Timeframe: baseline, 3 monthsPopulation: 21 care partners in the intervention and 17 in the waitlist group reported quality of life at 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.
Outcome measures
| Measure |
Intervention
n=21 Participants
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.
|
Wait-list
n=17 Participants
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.
|
|---|---|---|
|
Change in Quality of Life
|
41.5 score on a scale
Standard Deviation 6.9
|
35.5 score on a scale
Standard Deviation 7.0
|
PRIMARY outcome
Timeframe: baseline, 3 monthsPopulation: 21 care partners in the intervention and 17 in the waitlist reported negative emotions at 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.
Outcome measures
| Measure |
Intervention
n=21 Participants
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.
|
Wait-list
n=17 Participants
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.
|
|---|---|---|
|
Change in Negative Emotions
|
1.8 score on a scale
Standard Deviation .54
|
2.0 score on a scale
Standard Deviation .50
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-list
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place