Stress Reduction Study for Partners of Early Stage Dementia

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

June 21, 2018

First Posted Date ^ICMJE

October 1, 2018

Last Update Posted Date

October 1, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

June 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

change in positive affect[ Time Frame: day 16; 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.

change in depressive symptoms[ Time Frame: day 16; 3 months ]

10-item Center for Epidemiologic Studies of Depression Scale (CESD). Participants rate on a scale from 1 to 4. Higher numbers indicate more depressive symptoms.

change in emotion regulation[ Time Frame: day 16; 3 months ]

Difficulties in Emotion Regulation Scale (DERS; 2004). Participants rate 36 emotion regulation skills on a scale from 1 to 5. Higher scores indicate more difficulty regulating emotions.

change in support quality[ Time Frame: day 16; 3 months ]

We will also assess both partners' perceptions of support quality using a 10-item measure developed and validated by Brooke Feeney. Items include "My spouse is always there for me whenever I need him/her", and "I can count on my spouse to comfort and help me when I need it." Items are rated on a scale from 1 (disagree strongly) to 5 (agree strongly). Greater numbers indicate greater support quality.

change in caregiver burden[ Time Frame: day 16; 3 months ]

Spouses only will complete the short form Zarit Burden Interview which consist of 12 items rated from 0 (never) to 4 (nearly always). Items include, "Do you feel that because of the time you spend with your relative that you don't have enough time for yourself?" and "Do you feel angry when you are around your relative?"

change in perceived stress[ Time Frame: day 16; 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

Stress Reduction Study for Partners of Early Stage Dementia

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Other

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: 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.

Study Arms

Experimental: Intervention
Other: Wait-list
Participants will get the WOOP training after the last outcome assessment.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

May 30, 2020

Estimated Primary Completion Date

June 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion/Exclusion Criteria: - The couple is married or in a cohabiting, committed relationship. - One partner has early 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. - The spouse will have to score 27 or higher on the MMSE. - Both participants must agree to participate and complete baseline interviews. - Both partners are at least 60 years old.

Sex/Gender

Sexes Eligible for Study:

All

Ages

60 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

，

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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