Stress Reduction Study for Partners of Early Stage Dementia

赞助:

合作者:

信息的提供 (责任方):

，

追踪信息

首次提交日期 ^ICMJE

June 21, 2018

首次发布日期e ^ICMJE

October 1, 2018

最后更新发布日期

October 1, 2018

预计研究开始日期 ^ICMJE

October 1, 2018

预计主要完成日期

June 30, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^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.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

[ Time Frame: ]

描述性信息

简略标题 ^ICMJE

Stress Reduction Study for Partners of Early Stage Dementia

正式标题 ^ICMJE

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

简要概况

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.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Crossover Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Other

适用条件 ^ICMJE

干预项目 ^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.

研究工具

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

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

100

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

May 30, 2020

预计主要完成日期

June 30, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^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.

性别

参与研究的性别:

All

年龄

最小年龄：60 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Undecided

责任方

，

研究赞助商 ^ICMJE

Yale University

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

请使用微信扫码报名