N/A
Completed N=90
Stress Reduction Study for Partners of Early Stage Dementia
Dementia Caregiving
Source: ClinicalTrials.gov NCT03691428 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Change in Perceived Stress — 13.6; 17.8 score on a scale — p=<.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Perceived Stress |
13.6; 17.8 | <.05 sig |
| PRIMARY Change in Positive Affect |
3.60; 3.20 | <.05 sig |
| PRIMARY Change in Depressive Symptoms |
5.4; 9.75 | <.05 sig |
| PRIMARY Change in Quality of Life |
41.5; 35.5 | <.05 sig |
| PRIMARY Change in Negative Emotions |
1.8; 2.0 | <.05 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03691428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.