Completed

NCT Number: NCT03691428

Stress Reduction Study for Partners of Early Stage Dementia

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.

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Key information

Conditions

Dementia Caregiving

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joan Monin

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wish Outcome Obstacle Plan

Behavioral

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

National Institute on Aging (NIA)

Registry information

Official study title

A Daily Self-Regulation Intervention for Persons With Early Stage Alzheimer's Disease and Related Dementias and Their Spouses

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Oct 1, 2018
Registry last updated: Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.