Pre-Pilot: Adapting and Testing an Evidence-Based Emotion Regulation Therapy for Use by Caregivers of Individuals With Alzheimer's Disease and Related Dementias (ADRD)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Positive and Negative Affect as Measured by the Positive and Negative Affect Scale (PANAS)
研究概览
简要总结
The proposed pre-pilot project seeks to adapt an evidence-based psychosocial intervention-Pain Adaptation Therapy (PATH)-that employs emotion regulation, behavioral activation, and problem-solving skills training, that will be augmented with a caregiver (CG) education component, for use by CGs of individuals with Alzheimer's Disease and Related Dementias (ADRD).
详细描述
The study team will conduct an uncontrolled pre-pilot test of an adapted PATH-Care intervention with family CGs of persons with ADRD (target N=15). Following the informed consent process, screening, and enrollment, participants will complete a baseline assessment, 8 PATH-Care sessions with short feedback interviews, tablet-based exercises, and a post-intervention assessment.
Primary Objective(s): To adapt the existing PATH intervention as a tool to mitigate negative emotions and stress experienced by informal CGs of individuals with ADRD, by employing an evidence-based user-center design protocol and obtaining additional suggestions for program refinement through an uncontrolled usability study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking
- •Informal caregiver of an individual with ADRD diagnosis
- •Lives with or near the care recipient
- •Provides at least 10 hours of care per week to a person with ADRD
- •Has provided care to a person with ADRD for 6 months or more, prior to enrollment
- •Cognitively intact (Score of ≥ 26 on adjusted MoCA-Blind)
- •Score of ≥ 12 on the Negative Affect Scale of Positive and Negative Affect Schedule OR at least one significant negative emotion (score of ≥ 3)
排除标准
- •Non-English speaking
- •Paid caregiver
- •Care recipient does not have ADRD diagnosis
- •Provides care for less than 10 hours per week
- •Has provided care for less than 6 months, prior to enrollment
- •Care recipient is currently enrolled in hospice
- •Meets criteria for severe Major Depression (Montgomery Asberg Depression Rating Scale ≥ 30) that may require hospitalization
- •Significant Cognitive impairment (Score of < 26 on adjusted MoCA-Blind)
- •Score of < 12 on the Negative Affect Scale of Positive and Negative Affect Schedule or no significant negative emotion
研究组 & 干预措施
PATH-Care
Problem Adaptation THerapy (PATH) adapted for caregivers along with tablet based exercises to enhance and reinforce the therapy sessions.
干预措施: PATH-Care (Other)
结局指标
主要结局
Change in Positive and Negative Affect as Measured by the Positive and Negative Affect Scale (PANAS)
时间窗: At baseline; at week 10 (post-intervention)
The 20-item self-report Positive and Negative Affect Scale (PANAS-GEN) asks participants to describe to what extent they feel different feelings and emotions on average. Respondents answer on a five-point scale: 1=Very slightly or not at all, 2=A little, 3=Moderately, 4=Quite a bit, 5=Extremely. There are different subscales within this measure with 10 questions measuring positive affect, and 10 measuring negative affect. These have scores ranging from 10-50 with a higher score indicating higher positive affect, and a lower score indicating lower negative affect respectively.
Change in depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS-S)
时间窗: At baseline; at week 10 (post-intervention)
The 9-item self-report Montgomery-Asberg Depression Rating Scale asks participants about items like sadness, inner tension, sleep, and concentration. Respondents answer on a 7-point scale loosely by: 0=Normal, 2=Slight reduction, 4=Moderate reduction, and 6=Completely unable. These responses are personalized to the question a little more specifically. Scores range from 0-54 with a higher score indicating higher depression.
Change in caregiver burden as measured by Zarit Burden Interveiw (ZBI-12)
时间窗: At baseline; at week 10 (post-intervention)
The 12-item self-report Zarit Burden Interview Scale asks participants "do you feel...?" with responses about caregiver burden like anger, stress, and social life. Respondents answer on a 5-point scale: 0= Never, 1=Rarely, 2=Sometimes, 3=Quite Frequently, 4=Nearly Always. Scores range from 0-48 with a higher score indicating higher burden.
次要结局
- Change in positive aspects of caregiving as measured by the Positive Aspects of Caregiving scale (PAC)(At baseline; at week 10 (post-intervention))
- Change in efficacy and preparedness as measured by the Preparedness Caregiving Scale (PCS)(At baseline; at week 10 (post-intervention))
- Change in emotion regulatory ability as measured by the Emotion Regulation Questionnaire (CERQ)(At baseline; at week 10 (post-intervention))
- Satisfaction as measured by Client Satisfaction Questionnaire (CSQ-3)(At week 10 (post-intervention))
- Usable intervention as measured by the System Usability Scale(At week 10 (post-intervention))
- Feasibility, Acceptability, and Usability of PATH-Care intervention(At week 10 (post-intervention))