Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05949047
Status:
RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-04-10
Brief Title:
Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimers Disease
Sponsor:
Bryan Denny
Organization:
William Marsh Rice University
Study Overview
Official Title:
Biobehavioral Mechanisms of Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Alzheimers Disease AD and Alzheimers 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 ie 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 ie appraising an emotional stimulus as an objective impartial observer and reinterpretation ie 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 ie 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
Detailed Description:
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 ie reducing perceived stress caregiver burden and depressive symptoms in unpaid primary caregivers of persons diagnosed with Alzheimers 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 ie 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 ie appraising an emotional stimulus as an objective impartial observer and reinterpretation ie 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 ie 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 ie 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
Sufficient power to assess self-reported negative affect outcomes will be achieved by recruiting 90 participants per training condition This sample size estimate is based upon a power analysis for detecting an approximate effect size d 05 previously reported for within and between-subjects behavioral analyses of longitudinal reappraisal training data Power analyses using this approximate effect size indicate over 95 power alpha 005 to detect within-group effects and over 90 power alpha 005 to detect between- group effects should be achieved with 70 participants per condition Assuming all-cause attrition of 20 which reflects a liberal upper bound given past participant attrition rates of approximately 10 in longitudinal studies performed by the current study team the sample size should provide sufficient power to assess this outcome Post-attrition the investigators expect to have analyzable complete data for 72-81 participants per condition
Power analysis for caregiver heart rate variability HRV
Sufficient power to assess respiratory sinus arrhythmia outcomes will be achieved by recruiting 90 participants per training condition This sample size estimate is based upon a power analysis using an approximate effect size d 05 previously obtained for within and between-subjects analyses of HRV data Power analyses using this approximate effect size indicate over 95 power alpha 005 to detect within- group effects and over 90 power alpha 005 to detect between-group effects should be achieved with 70 participants per condition Assuming all-cause attrition of 20 which reflects a liberal upper bound given past participation attrition rates in longitudinal studies performed by the current study team of approximately 10 the sample size should provide sufficient power to assess this outcome Post-attrition the investigators expect to have analyzable complete data for 72-81 participants per condition
Power analysis for caregiver perceived stress caregiver burden depressive symptoms
Sufficient power to assess questionnaire outcomes eg perceived stress caregiver burden depressive symptoms will be achieved by recruiting 90 participants per training condition This sample size estimate is based upon a power analysis using an approximate effect size d 05 previously reported for within and between-subjects analyses of questionnaire reports measuring these variables eg depressive symptoms perceived stress Power analyses using this approximate effect size indicate over 95 power alpha 005 to detect within-group effects and over 90 power alpha 005 to detect between-group effects should be achieved with 70 participants per condition Assuming all-cause attrition of 20 which reflects a liberal upper bound given past participation attrition rates in longitudinal studies performed by the current study team of approximately 10 the sample size should provide sufficient power to assess this outcome Post-attrition the investigators expect to have analyzable complete data for 72-81 participants per condition
Power analysis for care recipient affect and quality of life
Sufficient power to assess care recipient affect and quality of life will be achieved by recruiting 90 participants per training condition While the precise anticipated effect size for change over time in these care recipient measures as a function of caregiver cognitive emotion regulation training is not known and not expected to be large a power analysis using a small effect size d 03 indicates 80 power alpha 005 to detect within-group effects should be achieved with 71 participants per condition Assuming all-cause attrition of 20 which reflects a liberal upper bound given past participation attrition rates in longitudinal studies performed by the current study team of approximately 10 the sample size should provide sufficient power to assess this outcome Post-attrition the investigators expect to have analyzable complete data for 72-81 participants per condition
Data Analyses
Data analysis will primarily use linear mixed models incorporating fixed effects for Training Group Distancing Reinterpretation No Regulation Control Session and Trial Type for analyses involving the reappraisal task Look Neutral Look Negative and Reappraise Negative and their fixed-effect interactions as well as a random effect consisting of an intercept main effect for each participant In an exploratory follow-up the investigators will additionally examine models using a random slope per participant The outcome variables will be changes in self-reported positive and negative affect via EMA and HRV RMSSD Aim 1 and changes in health-relevant behavioral outcomes Aim 2 In these analyses gender age caregiver relationship to care recipient and baseline caregiving distress burden will be incorporated as covariates Importantly the investigators also anticipate having sufficient power to conduct exploratory analyses on the effect of caregiver gender and age on the hypothesized effects all Aims given that the investigators will ensure gender balance in each group by oversampling male caregivers see Recruitment and Retention Plan This information may help inform future intervention design and assessment Stage II and beyond that may arise from the results of this work Aim 3 will be investigated using multilevel mediation modeling involving training group assignment as the higher-level predictor X self-reported positive and negative affect and HRV data as individual-level mediators M and health-relevant behavior as individual-level outcome variables Y ie a 2-1-1 multilevel mediation model Relevant covariates indicated above will be incorporated in all mediation models
Missing data will be imputed using random forest imputation which mines for complexities interactions nonlinearities in the data while achieving more robust cross-validated prediction of missing-at-random MAR data Loss to follow-up will be mitigated via systematic tracking of participant progress during the experiment eg timeliness and completeness of training via Qualtrics from T1-T7 completion rate for daily EMA pings and timeliness and completeness of questionnaires An experimenter will directly contact participants who do not complete study components on schedule ie not completing daily training responding to fewer than 1 EMA ping per day or not completing questionnaires on schedule with reminders about the study schedule and assist with any questions This checking and reminder system will be in addition to the automated SMS reminders sent via SurveySignal
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 ie 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
Sufficient power to assess self-reported negative affect outcomes will be achieved by recruiting 90 participants per training condition This sample size estimate is based upon a power analysis for detecting an approximate effect size d 05 previously reported for within and between-subjects behavioral analyses of longitudinal reappraisal training data Power analyses using this approximate effect size indicate over 95 power alpha 005 to detect within-group effects and over 90 power alpha 005 to detect between- group effects should be achieved with 70 participants per condition Assuming all-cause attrition of 20 which reflects a liberal upper bound given past participant attrition rates of approximately 10 in longitudinal studies performed by the current study team the sample size should provide sufficient power to assess this outcome Post-attrition the investigators expect to have analyzable complete data for 72-81 participants per condition
Power analysis for caregiver heart rate variability HRV
Sufficient power to assess respiratory sinus arrhythmia outcomes will be achieved by recruiting 90 participants per training condition This sample size estimate is based upon a power analysis using an approximate effect size d 05 previously obtained for within and between-subjects analyses of HRV data Power analyses using this approximate effect size indicate over 95 power alpha 005 to detect within- group effects and over 90 power alpha 005 to detect between-group effects should be achieved with 70 participants per condition Assuming all-cause attrition of 20 which reflects a liberal upper bound given past participation attrition rates in longitudinal studies performed by the current study team of approximately 10 the sample size should provide sufficient power to assess this outcome Post-attrition the investigators expect to have analyzable complete data for 72-81 participants per condition
Power analysis for caregiver perceived stress caregiver burden depressive symptoms
Sufficient power to assess questionnaire outcomes eg perceived stress caregiver burden depressive symptoms will be achieved by recruiting 90 participants per training condition This sample size estimate is based upon a power analysis using an approximate effect size d 05 previously reported for within and between-subjects analyses of questionnaire reports measuring these variables eg depressive symptoms perceived stress Power analyses using this approximate effect size indicate over 95 power alpha 005 to detect within-group effects and over 90 power alpha 005 to detect between-group effects should be achieved with 70 participants per condition Assuming all-cause attrition of 20 which reflects a liberal upper bound given past participation attrition rates in longitudinal studies performed by the current study team of approximately 10 the sample size should provide sufficient power to assess this outcome Post-attrition the investigators expect to have analyzable complete data for 72-81 participants per condition
Power analysis for care recipient affect and quality of life
Sufficient power to assess care recipient affect and quality of life will be achieved by recruiting 90 participants per training condition While the precise anticipated effect size for change over time in these care recipient measures as a function of caregiver cognitive emotion regulation training is not known and not expected to be large a power analysis using a small effect size d 03 indicates 80 power alpha 005 to detect within-group effects should be achieved with 71 participants per condition Assuming all-cause attrition of 20 which reflects a liberal upper bound given past participation attrition rates in longitudinal studies performed by the current study team of approximately 10 the sample size should provide sufficient power to assess this outcome Post-attrition the investigators expect to have analyzable complete data for 72-81 participants per condition
Data Analyses
Data analysis will primarily use linear mixed models incorporating fixed effects for Training Group Distancing Reinterpretation No Regulation Control Session and Trial Type for analyses involving the reappraisal task Look Neutral Look Negative and Reappraise Negative and their fixed-effect interactions as well as a random effect consisting of an intercept main effect for each participant In an exploratory follow-up the investigators will additionally examine models using a random slope per participant The outcome variables will be changes in self-reported positive and negative affect via EMA and HRV RMSSD Aim 1 and changes in health-relevant behavioral outcomes Aim 2 In these analyses gender age caregiver relationship to care recipient and baseline caregiving distress burden will be incorporated as covariates Importantly the investigators also anticipate having sufficient power to conduct exploratory analyses on the effect of caregiver gender and age on the hypothesized effects all Aims given that the investigators will ensure gender balance in each group by oversampling male caregivers see Recruitment and Retention Plan This information may help inform future intervention design and assessment Stage II and beyond that may arise from the results of this work Aim 3 will be investigated using multilevel mediation modeling involving training group assignment as the higher-level predictor X self-reported positive and negative affect and HRV data as individual-level mediators M and health-relevant behavior as individual-level outcome variables Y ie a 2-1-1 multilevel mediation model Relevant covariates indicated above will be incorporated in all mediation models
Missing data will be imputed using random forest imputation which mines for complexities interactions nonlinearities in the data while achieving more robust cross-validated prediction of missing-at-random MAR data Loss to follow-up will be mitigated via systematic tracking of participant progress during the experiment eg timeliness and completeness of training via Qualtrics from T1-T7 completion rate for daily EMA pings and timeliness and completeness of questionnaires An experimenter will directly contact participants who do not complete study components on schedule ie not completing daily training responding to fewer than 1 EMA ping per day or not completing questionnaires on schedule with reminders about the study schedule and assist with any questions This checking and reminder system will be in addition to the automated SMS reminders sent via SurveySignal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AG074229-01A1 | NIH | None | httpsreporternihgovquickSearch1R01AG074229-01A1 |