Biobehavioral Mechanisms of Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Self-reported negative affect
研究概览
简要总结
Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) not only exact a heavy toll on patients, they also impose an enormous emotional, physical, and financial burden on unpaid, often family, caregivers. The strain of providing care for a loved one diagnosed with AD, often across several years, is associated with elevated depression risk and poorer overall health. Emotion regulation skills represent an ideal target for psychological intervention to promote healthy coping in ADRD caregivers. The project seeks to use an experimental medicine approach to test the efficacy and biobehavioral mechanisms of a novel, relatively brief, targeted, scalable, smartphone-based cognitive emotion regulation intervention aimed at improving psychological outcomes (i.e., reducing perceived stress, caregiver burden, and depressive symptoms) in ADRD unpaid primary caregivers as well as examine potential benefits of the caregiver intervention on quality of life in care recipients. Cognitive reappraisal is the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal can be operationalized via two primary tactics: psychological distancing (i.e. appraising an emotional stimulus as an objective, impartial observer) and reinterpretation (i.e., imagining a better outcome than what initially seemed apparent). The project will investigate the efficacy and underlying biobehavioral mechanisms of a novel, one-week cognitive reappraisal intervention in this population, with follow-up assessments at 2 weeks, 4 weeks, and 3 months. ADRD unpaid primary caregivers will be randomly assigned to receive training in either distancing, reinterpretation, or a no regulation natural history control condition, with ecological momentary assessments of self-reported positive and negative affect, remotely- collected psychophysiological health-related biomarkers (i.e., heart rate variability data) using pre-mailed Polar H10 chest bands, and health-related questionnaire reports. Distancing training is expected to result in longitudinal reductions in self-reported negative affect, longitudinal increases in positive affect, and longitudinal increases in HRV that are larger than those attributable to reinterpretation training and no-regulation control training.
详细描述
The objective of the research is to use an experimental medicine approach to test the efficacy and biobehavioral mechanisms of a novel, relatively brief, targeted, scalable, smartphone-based cognitive emotion regulation intervention aimed at improving psychological outcomes (i.e., reducing perceived stress, caregiver burden, and depressive symptoms) in unpaid primary caregivers of persons diagnosed with Alzheimer's Disease or a related dementia (ADRD) as well as examine potential benefits of the caregiver intervention on quality of life in care recipients. Cognitive reappraisal (i.e., the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way) represents a highly promising target for psychological intervention in ADRD caregivers. Reappraisal can be operationalized via two primary tactics: psychological distancing (i.e. appraising an emotional stimulus as an objective, impartial observer) and reinterpretation (i.e., imagining a better outcome than what initially seemed apparent). The project builds upon promising preliminary work to investigate the efficacy and underlying biobehavioral mechanisms of a novel, one-week cognitive reappraisal intervention in this population. ADRD unpaid primary caregivers will be randomly assigned to receive training in either distancing, reinterpretation, or a no regulation natural history control condition (Look Only), with one-week of active smartphone-based reappraisal training, with follow-up assessments at 2 weeks, 4 weeks, and 3 months, with longitudinal collection of self-reported positive and negative affect, ecological momentary assessments of daily stress, remotely-collected psychophysiological health-related biomarkers (i.e., heart rate variability data collected using a pre-mailed H10 strap and phone app using bluetooth), and health-related questionnaire reports. The study aims to mechanistically relate changes in psychological and psychophysiological function to prediction of health-relevant behavioral outcomes during a novel emotion regulation intervention never before implemented in this stressed, high risk group.
This research represents a Phase I, Stage I clinical trial. The primary endpoints are the assessments of the psychological and psychophysiological mechanisms mediating behavior change as a function of the cognitive emotion regulation intervention. Psychological mechanisms will be assessed by changes in self-reported positive and negative affect. Psychophysiological mechanisms will be investigated by analysis of heart rate variability data. The secondary endpoint is testing the efficacy of the intervention via assessment of psychological outcomes (i.e., the behavior change, as represented in changes in perceived stress, caregiver burden, and depressive symptoms), as well as care recipient quality of life.
270 ADRD unpaid primary caregivers will be recruited to participate in this study. This research involves random assignment of ADRD caregiver participants to either distancing training, reinterpretation training, or a no regulation natural history control condition (Look Only), as described above, using a parallel intervention model. In particular, the investigators will pseudorandomly assign participants to training groups via initially randomly interspersing 270 condition assignments (90 per cell) and then assigning participants in order accordingly. Male ADRD caregivers as well as caregivers from underrepresented racial and ethnic groups will be oversampled to ensure parity of male and female caregivers as well as equitable representation of underrepresented groups in the sample. Trained experimenters from the study team will administer all 3 conditions (distancing, reinterpretation, and Look Only) with equal frequency. The identity of the experimenter will be incorporated as a covariate during data analysis. Fidelity to the experimental protocol will be maintained via a standardized script for emotion regulation training, modified for each of the three conditions (Distancing, Reinterpretation, Look Only); direct PI training of the Project Coordinator and all research assistants who will acquire data on this protocol; and regular adherence monitoring via ongoing PI observation of Project Coordinator and research assistant training implementation. In addition, the investigators will audiotape training sessions (optionally, via informed consent), with PI review of a randomly-selected 10% of recordings to further ensure fidelity to the protocol.
Power Analyses
Power analysis for caregiver self-reported negative affect:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Healthy Adult Caregivers
- •Unpaid primary caregiver of patient with Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD)
- •At least 18 years of age, with no maximum age, provided that all other inclusion/
排除标准
- •Must be able to speak, read, and write in English
- •Must be free of any current or past DSM diagnosis (i.e. healthy adults), with the exception of current or past mood or anxiety disorders or past substance-related disorders (i.e., current or past mood or anxiety disorders and/or past substance-related disorders would not represent an exclusion factor)
- •Must have a smartphone. This represents any major iOS or Android-based smartphone. The smartphone will also be used for collection of ecological momentary assessment (EMA) data via SurveySignal.
- •Must provide significant level of caregiving to their care recipient
- •Must be at least minimally-stressed
- •Cognitively Impaired Adults
- •Must have diagnosed with Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD)
- •Must be the care recipient of the primary caregiver who is completing the study
- •Must be able to understand and willing to complete a questionnaire and the consent form
- •Must have minimum level of dementia symptoms
- •Exclusion Criteria:
- •Healthy Adult Caregivers
- •Current or past psychiatric disorders (e.g., psychotic and personality disorders) with the exception of current or past mood or anxiety disorders or past substance-related disorders (i.e., current or past mood or anxiety disorders and/or past substance-related disorders would not represent an exclusion factor)
- •Currently receiving psychotherapy that specifically addresses caregiver burden/distress or employs cognitive reappraisal as a major component
- •Significant visual, auditory, or cognitive impairment that compromises their ability to understand and complete the task
- •Caregiver participants who cease meeting inclusion criteria during the study will be dismissed from the study and compensated pro-rata.
- •Has formerly participated in a study from our lab involving the same or essentially same design (e.g., former participants who provided pilot/preliminary data for this study)
- •Cognitively Impaired Adults
- •The care recipient does not wish to participate, and/or their caregiver does not want them to participate
- •Significant visual, auditory, or cognitive impairment that compromises their ability to understand and complete questionnaires, even with their caregiver's help will exclude them from the study
- •Has formerly participated in a study from our lab involving the same or essentially same design (e.g., former participants who provided pilot/preliminary data for this study)
研究组 & 干预措施
Reinterpretation
Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction via videoconference in which detailed instructions for implementation of the reinterpretation strategy is explained (i.e. imagining a better outcome than what initially seemed apparent).
干预措施: Cognitive Emotion Regulation Training via Reinterpretation (Behavioral)
Distancing
Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction via videoconference in which detailed instructions for implementation of the distancing strategy is explained (i.e. appraising an emotional stimulus as an objective, impartial observer).
干预措施: Cognitive Emotion Regulation Training via Psychological Distancing (Behavioral)
No regulation "Look Only"
The No Regulation "Look Only" Control group will serve as a habituation and natural history control; they will see the same emotional images, but they will only be cued to look and respond naturally for all trials.
结局指标
主要结局
Self-reported negative affect
时间窗: During Sessions Day 1 - Day 7; this cycle is 7 days
Self-reported negative affect data collected during completion of emotion regulation task via smartphone
Caregiver burden
时间窗: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Caregiver burden assessed via the Caregiver Burden Scale on a scale of 0 to 4, with 0 indicating "Never" and 4 indicating "Nearly Always". The greater the total score, the worse the outcome. Change in self-reports of caregiver burden assessed at the following timepoints:
Ecological momentary assessment of positive and negative affect
时间窗: During Sessions Day 1 - Day 7; this cycle is 7 days
Ecological momentary assessment (EMA) of positive and negative affect collected during 4 daily afternoon EMA pings via smartphone
Heart rate variability
时间窗: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Heart rate variability measured via smartphone in conjunction with a Bluetooth-connected H10 Polar Chest Band. Change in heart rate variability assessed at the following timepoints:
Perceived stress
时间窗: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Perceived stress assessed via the Perceived Stress Scale on a scale of 0 to 4, with 0 indicating "Never" and 4 indicating "Very Often". A higher overall score on the stress scale indicates a worse outcome. Change in self-reports of perceived stress assessed at the following timepoints:
Caregiver quality of life
时间窗: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Caregiver quality of life assessed via the Caregiver Quality of Life Index on a scale of 0 to 4, with 0 indicating "Not at all" and 4 indicating "Very much". A higher overall score on the Caregiver quality of life index indicates a higher quality of life and better outcome. Change in self-reports of caregiver quality of life assessed at the following timepoints:
Depressive symptoms
时间窗: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Depressive systems assessed via the Center for Epidemiological Studies-Depression (CES-D) Depression Inventory on a scale of 0 to 3, with 0 indicating "Rarely or none of the time (less than 1 day)," and 3 indicating "Most or all of the time (5-7 days)". The higher the score on the CES-D Depression Inventory, the worse the outcome. Change in self-reports of depressive symptoms assessed at the following timepoints:
Difficulty in regulating emotion
时间窗: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Difficulty in regulating emotion will be assessed using the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF). There are 5 possible responses to a series of questions: almost never (0-10%), sometimes (11-35%), about half of the time (36-65), most of the time (66%-90%), almost always (91-100%). "Almost never" is the minimum score and "almost always) is the maximum score. Higher scores reflect a worse outcome or greater difficulty with emotion regulation. Change in self-reports of regulating emotions assessed at the following timepoints:
Interpersonal regulation
时间窗: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Interpersonal regulation efficacy assessed via the Interpersonal Regulation Questionnaire on a scale of 1 to 7, with a score of 1 indicating "strongly disagree" and a scale of 7 indicating "strongly agree". A higher score on this questionnaire indicates a change in self-reports of interpersonal regulation assessed at the following timepoints:
Positive and negative affect
时间窗: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Positive and negative affect assessed via the Positive and Negative Affect Schedule (PANAS) on a scale of 1 to 5, with a score of 1 indicating "Very slightly or not at all" and a score of 5 indicating "extremely". It is scored using two categories, a positive affect score and a negative affect score. Those with a higher positive affect and lower negative affect score have the most positive outcome. Change in self-reports of positive and negative affect assessed at the following timepoints:
Empathy
时间窗: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Empathy Assessed via the Interpersonal Reactivity Index (IRI) on a scale of 0 to 4, with a score of 0 indicating "does not describe me well" and a score of 4 indicating "describes very well". A higher score on this index indicates greater levels of empathy. In this study, the degree of empathy the individual scores does not correlate to a better or worse outcome. The Change in self-reports of empathy assessed at the following timepoints:
次要结局
- Revised Memory and Behavior Problem Checklist (RMBPC)(Month 3 (this period is one day long, 3 months after the initial visit))
- Care recipient quality of life(Month 3 (this period is one day long, 3 months after the initial visit))
- Reappraisal usage frequency(Month 3; this period one day long, 3 months after the initial visit))
- Quick Dementia Rating System (QDRS)(Month 3 (this period is one day long, 3 months after the initial visit))
- Care recipient affect(Month 3 (this period is one day long, 3 months after the initial visit))
- Reappraisal usage frequency(Initial training (Day 0))
- Reappraisal usage frequency(Day 7)
- Reappraisal usage frequency(Day 14)
- Reappraisal usage frequency(Day 28)
- Quick Dementia Rating System (QDRS)(Initial training (Day 0))
- Quick Dementia Rating System (QDRS)(Day 7)
- Quick Dementia Rating System (QDRS)(Day 14)
- Quick Dementia Rating System (QDRS)(Day 28)
- Care recipient affect(Initial training (Day 0))
- Care recipient affect(Day 7)
- Care recipient affect(Day 14)
- Care recipient affect(Day 28)
- Care recipient quality of life(Initial training (Day 0))
- Care recipient quality of life(Day 7)
- Care recipient quality of life(Day 14)
- Care recipient quality of life(Day 28)
研究者
Bryan Denny
Assistant Professor
William Marsh Rice University