Stress Clinical Trial
Official title:
Biobehavioral Mechanisms of Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
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.
Status | Recruiting |
Enrollment | 270 |
Est. completion date | May 31, 2027 |
Est. primary completion date | November 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 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/exclusion criteria are met - 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 at least 4 hours of active caregiving a day to their care recipient in the care recipient's home - Must be at least minimally-stressed (i.e., CES-D score of at least 16) 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 a Quick Dementia Rating System (QDRS) rating of at least 6 Exclusion Criteria: Healthy Adult Caregivers - Current or past DSM diagnosis, 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 (e.g., if the care recipient enters a skilled nursing facility during the study and inclusion criteria above are no longer met) 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) |
Country | Name | City | State |
---|---|---|---|
United States | Rice University | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Bryan Denny | National Institute on Aging (NIA) |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-reported negative affect | Self-reported negative affect data collected during completion of emotion regulation task via smartphone | During Sessions Day 1 - Day 7; this cycle is 7 days | |
Primary | Ecological momentary assessment of positive and negative affect | Ecological momentary assessment (EMA) of positive and negative affect collected during 4 daily afternoon EMA pings via smartphone | During Sessions Day 1 - Day 7; this cycle is 7 days | |
Primary | Heart rate variability | 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: | Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 | |
Primary | Perceived stress | 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: | Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 | |
Primary | Caregiver burden | 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: | Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 | |
Primary | Caregiver quality of life | 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: | Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 | |
Primary | Depressive symptoms | 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: | Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 | |
Primary | Difficulty in regulating emotion | 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: | Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 | |
Primary | Positive and negative affect | 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: | Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 | |
Primary | Interpersonal regulation | 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: | Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 | |
Primary | Empathy | 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: | Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 | |
Secondary | Reappraisal usage frequency | General/overall reappraisal usage frequency assessed via the Emotion Regulation Questionnaire | Initial training (Day 0) | |
Secondary | Reappraisal usage frequency | General/overall reappraisal usage frequency assessed via the Emotion Regulation Questionnaire | Day 7 | |
Secondary | Reappraisal usage frequency | General/overall reappraisal usage frequency assessed via the Emotion Regulation Questionnaire | Day 14 | |
Secondary | Reappraisal usage frequency | General/overall reappraisal usage frequency assessed via the Emotion Regulation Questionnaire | Day 28 | |
Secondary | Reappraisal usage frequency | General/overall reappraisal usage frequency assessed via the Emotion Regulation Questionnaire | Month 3; this period one day long, 3 months after the initial visit) | |
Secondary | Quick Dementia Rating System (QDRS) | Caregiver-reported assessment of cognitive and behavioral function of care recipients. The QDRS is scored on a continuous scale with a range of 0-30. Higher scores suggest more impairment. | Initial training (Day 0) | |
Secondary | Quick Dementia Rating System (QDRS) | Caregiver-reported assessment of cognitive and behavioral function of care recipients. The QDRS is scored on a continuous scale with a range of 0-30. Higher scores suggest more impairment. | Day 7 | |
Secondary | Quick Dementia Rating System (QDRS) | Caregiver-reported assessment of cognitive and behavioral function of care recipients. The QDRS is scored on a continuous scale with a range of 0-30. Higher scores suggest more impairment. | Day 14 | |
Secondary | Quick Dementia Rating System (QDRS) | Caregiver-reported assessment of cognitive and behavioral function of care recipients. The QDRS is scored on a continuous scale with a range of 0-30. Higher scores suggest more impairment. | Day 28 | |
Secondary | Quick Dementia Rating System (QDRS) | Caregiver-reported assessment of cognitive and behavioral function of care recipients. The QDRS is scored on a continuous scale with a range of 0-30. Higher scores suggest more impairment. | Month 3 (this period is one day long, 3 months after the initial visit) | |
Secondary | Revised Memory and Behavior Problem Checklist (RMBPC) | The Revised Memory and Behavior Problem Checklist involves the caregiver a) rating the frequency of observable behavior problems in the dementia patient during the past week (1 = not in the past week, to 4 = daily or more often) and (b) their reaction to each behavior (e.g. how bothered or upset the caregiver feels when the behavior occurs with 0 = not at all to 4 = extremely).
Frequency Score: The total frequency score is computed to obtain a possible range of 0 to 4, where 0 is the lowest frequency of behavioral problems, and 4 is the highest frequency. Reaction Scoring: The total reaction score is computed in the same way, to obtain a possible range of 0 to 4, where 0 as the minimum reaction score (e.g., not being upset about the care recipient's behavioral problems) and 4 as the maximum reaction score (e.g., being extremely upset about the care recipient's behavioral problems). |
Month 3 (this period is one day long, 3 months after the initial visit) | |
Secondary | Care recipient affect | Care recipients will provide valence and arousal ratings by selecting the Self-Assessment Manikin that best exemplifies their emotional state in that moment. Their arousal rating is selected between 9 Manikins that range from a frowning face to a smiling face, with less arousal indicated by a frowning face and greater arousal indicated by a smiling face. Their valence rating is selected between 9 Manikins that range from a small bubble in their chest to a large, protruding bubble in their chest. The lower their valence rating is, the smaller the chest bubble appears. Change in self-reports of valence and arousal assessed at the following timepoints: | Initial training (Day 0) | |
Secondary | Care recipient affect | Care recipients will provide valence and arousal ratings by selecting the Self-Assessment Manikin that best exemplifies their emotional state in that moment. Their arousal rating is selected between 9 Manikins that range from a frowning face to a smiling face, with less arousal indicated by a frowning face and greater arousal indicated by a smiling face. Their valence rating is selected between 9 Manikins that range from a small bubble in their chest to a large, protruding bubble in their chest. The lower their valence rating is, the smaller the chest bubble appears. Change in self-reports of valence and arousal assessed at the following timepoints: | Day 7 | |
Secondary | Care recipient affect | Care recipients will provide valence and arousal ratings by selecting the Self-Assessment Manikin that best exemplifies their emotional state in that moment. Their arousal rating is selected between 9 Manikins that range from a frowning face to a smiling face, with less arousal indicated by a frowning face and greater arousal indicated by a smiling face. Their valence rating is selected between 9 Manikins that range from a small bubble in their chest to a large, protruding bubble in their chest. The lower their valence rating is, the smaller the chest bubble appears. Change in self-reports of valence and arousal assessed at the following timepoints: | Day 14 | |
Secondary | Care recipient affect | Care recipients will provide valence and arousal ratings by selecting the Self-Assessment Manikin that best exemplifies their emotional state in that moment. Their arousal rating is selected between 9 Manikins that range from a frowning face to a smiling face, with less arousal indicated by a frowning face and greater arousal indicated by a smiling face. Their valence rating is selected between 9 Manikins that range from a small bubble in their chest to a large, protruding bubble in their chest. The lower their valence rating is, the smaller the chest bubble appears. Change in self-reports of valence and arousal assessed at the following timepoints: | Day 28 | |
Secondary | Care recipient affect | Care recipients will provide valence and arousal ratings by selecting the Self-Assessment Manikin that best exemplifies their emotional state in that moment. Their arousal rating is selected between 9 Manikins that range from a frowning face to a smiling face, with less arousal indicated by a frowning face and greater arousal indicated by a smiling face. Their valence rating is selected between 9 Manikins that range from a small bubble in their chest to a large, protruding bubble in their chest. The lower their valence rating is, the smaller the chest bubble appears. Change in self-reports of valence and arousal assessed at the following timepoints: | Month 3 (this period is one day long, 3 months after the initial visit) | |
Secondary | Care recipient quality of life | Care recipients will rate their quality of life using the Quality of Life in Alzheimer's Disease Scale (QoL-AD). There are 4 possible responses to a series of questions: poor, fair, good, and excellent. "Poor" is the minimum score and "excellent" is the maximum score. Higher scores mean a better outcome or greater quality of life. Change in self-reports of care recipient quality of life at the following timepoints: | Initial training (Day 0) | |
Secondary | Care recipient quality of life | Care recipients will rate their quality of life using the Quality of Life in Alzheimer's Disease Scale (QoL-AD). There are 4 possible responses to a series of questions: poor, fair, good, and excellent. "Poor" is the minimum score and "excellent" is the maximum score. Higher scores mean a better outcome or greater quality of life. Change in self-reports of care recipient quality of life at the following timepoints: | Day 7 | |
Secondary | Care recipient quality of life | Care recipients will rate their quality of life using the Quality of Life in Alzheimer's Disease Scale (QoL-AD). There are 4 possible responses to a series of questions: poor, fair, good, and excellent. "Poor" is the minimum score and "excellent" is the maximum score. Higher scores mean a better outcome or greater quality of life. Change in self-reports of care recipient quality of life at the following timepoints: | Day 14 | |
Secondary | Care recipient quality of life | Care recipients will rate their quality of life using the Quality of Life in Alzheimer's Disease Scale (QoL-AD). There are 4 possible responses to a series of questions: poor, fair, good, and excellent. "Poor" is the minimum score and "excellent" is the maximum score. Higher scores mean a better outcome or greater quality of life. Change in self-reports of care recipient quality of life at the following timepoints: | Day 28 | |
Secondary | Care recipient quality of life | Care recipients will rate their quality of life using the Quality of Life in Alzheimer's Disease Scale (QoL-AD). There are 4 possible responses to a series of questions: poor, fair, good, and excellent. "Poor" is the minimum score and "excellent" is the maximum score. Higher scores mean a better outcome or greater quality of life. Change in self-reports of care recipient quality of life at the following timepoints: | Month 3 (this period is one day long, 3 months after the initial visit) |
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