Dementia CaregivingNCT03691428
Stress Reduction Study for Partners of Early Stage Dementia
A study testing Wish Outcome Obstacle Plan in people with Dementia Caregiving, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia Caregiving
- What is being tested?
- Wish Outcome Obstacle Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dementia Caregiving
- Being tested
- Wish Outcome Obstacle Plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wish Outcome Obstacle PlanBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Wish Outcome Obstacle Plan |
| Wait-list | Other | Participants will get the WOOP training after the last outcome assessment. Receives: Behavioral: Wish Outcome Obstacle Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3 months
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.
Measured: baseline, 3 months
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.
Measured: baseline, 3 months
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.
Measured: baseline, 3 months
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.
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start30 Jan 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia CaregivingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691428
- Sponsor's protocol ID
- 2000021852
- Other IDs
- R21AG055861-01A1
- Status last verified
- Feb 2024
- First submitted
- 21 Jun 2018
- Last updated
- 15 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34171086
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Daily Self-Regulation Intervention for Persons With Early Stage Alzheimer's Disease and Related Dementias and Their Spouses
- ClinicalTrials.gov ID
- NCT03691428
- Acronym / sponsor ID
- 2000021852
- Conditions
- Dementia Caregiving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Posted 8 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Wish Outcome Obstacle Plan |
| Wait-list | Other | Behavioral: Wish Outcome Obstacle PlanParticipants will get the WOOP training after the last outcome assessment. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wish Outcome Obstacle Plan1. 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. | Behavioural | Intervention, Wait-list |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34171086Monin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wish Outcome Obstacle Plan in people with Dementia Caregiving, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress (time frame: baseline, 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.