Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT05732038
The investigators aim to conduct a feasibility, proof of concept randomized controlled trial (RCT) of a smartphone app intervention (Healthy Minds Program; HMP) versus Wellness app (WA) among heterogeneous stressed caregivers of individuals with Alzheimer's disease and related dementias (ADRD). The investigators will test its feasibility (primary outcomes) and its preliminary effect in improvement in caregiver stress, emotional distress (depression and anxiety), and mindfulness. Participants will be randomized to one of the two conditions described above
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
Using the NIA 2 year R21 grant mechanisms, we will examine the feasibility (markers of acceptability and demand), and proof of concept of Healthy Minds Program (HMP) versus Wellness App (WA) in decreasing stress and emotional distress in heterogeneous, geographically diverse, stressed caregivers of individuals with Alzheimer's disease and related dementias (ADRD). Participants in each arm will be asked to practice for 10 min/day.
To achieve our aims, we will conduct a single blind, pilot, feasibility, proof of concept randomized controlled trial (RCT) of HMP (12 weeks, > 10 minutes daily) versus WA; 12 weeks, >10 minutes daily). Assessments will be conducted at baseline, post program (12 weeks later) and at 20 weeks follow-up (~2 months after post-test). Caregivers will also complete weekly assessments.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants assigned to the HMP group will be asked to complete a minimum of 10 minutes per day of meditation for 12 weeks. For the first four weeks, participants will listen to prescribed meditations that will teach them the foundations of mindfulness. During weeks 5-12, participants will have full access to the HMP meditation library.
Participants in the WA group will listen to a minimum of 10 minutes per day of a caregiver specific educational podcast (including topics such as "Caring for the Caregiver" or "Folate and Preventing Alzheimer's") delivered via a mobile app for the 12 weeks. The app contains one podcast per day for twelve weeks.
Time frame: 0 weeks
We will assess number of dementia caregivers enrolled from the number of caregivers that were eligible. Our primary aim focuses on feasibility of recruitment during the trial.
Time frame: 12 weeks
We will assess data from the Healthy Minds Program app and the Podcast app to measure adherence to the intervention and the control conditions. Our benchmark will be that >=70% of caregivers will complete >=75% of weekly prescribed minutes (>=10 minutes/day).
Time frame: 0 weeks
We will use the Credibility and Expectancy Questionnaire (CEQ) to assesses caregivers perceptions that the treatment will work after learning about the study. Scores range from 3-27; higher ratings indicate more belief that the program is logical and will help with the intended outcome.
Time frame: 12 weeks
This will be used to assess caregivers' satisfaction with the intervention. Scores range from 3 to 12, with higher values indicating higher satisfaction.
Time frame: 12 weeks
We will assess caregivers' perception of their app's prescription by asking, "Do you think that the amount of daily prescribed app content was: too little, just enough, or too much?"
Time frame: 12 weeks
We will assess caregivers' perception of emails and text message reminders by asking, "Do you think that the amount of emails/texts you received was: too little, just enough, too much?"
Time frame: 12 weeks
We will assess caregivers' perceptions of the study by asking, "Do you have any feedback about your experience in this program (content of the program, content of the text message reminders, etc.) that you would like to share?"
Time frame: 12 weeks
We will assess the feasibility of the weekly REDCap measures sent to patients by review of responses to ensure that >=70% caregivers will answer >=75%.
Time frame: 12 weeks
We will assess caregivers' perception of the amount of prompts and contact in situations where they were not adhering to their practice by asking "Do you think that the amount of prompts you received when you struggled with your practice was: too little, just enough, too much?"
Time frame: 20 weeks
We will assess the feasibility of the quantitative measures sent to caregivers with the benchmark of no questionnaires missing fully in >=25% caregivers.
Time frame: 0 weeks, 12 weeks, 20 weeks
We will use the Hospital Anxiety and Depression Scale HADS, a 14-item measure that assesses symptoms of emotional distress (anxiety and depression). The anxiety and depression sub-scale are each scored from 0-21, with higher scores indicating greater severity of symptoms. Scores can be summed to create a global emotional distress score (0-42).
Time frame: 0 weeks, 12 weeks, 20 weeks
We will use the Applied Mindfulness Process Scale (AMPS) to assess caregivers mindfulness. AMPS consists of 3 sub scales: de-centering, positive emotion regulation, and negative emotion regulation. Each sub scale is scored from 0-20. An overall score ranging from 0-60 can be obtained by summing all 15 items. Higher scores indicate greater mindfulness.
Time frame: 0-12 weeks, 20 weeks
We will use a stress thermometer scale (0-10) to assess how caregivers rate their level of stress each week: "During the past week, how would you rate your stress on a scale from 0-10? (0 = not at all; 10 = extremely stressed)?"
Time frame: 0-12 weeks, 20 weeks
We will use a mindfulness thermometer scale (0-10) to assess how caregivers rate their level of mindfulness each week: "During the past week, how would you rate your mindfulness on a scale from 0-10? (0 = not at all; 10 = extremely mindful)?"
Time frame: 0-12 weeks, 20 weeks
We will use an emotional distress thermometer scale (0-10) to assess how caregivers rate their level of distress each week: "During the past week, how would you rate your emotional distress on a scale from 0-10? (0 = not at all; 10 = extremely emotionally distressed)?"
Time frame: 12 weeks
We will use the Modified Patient Global Impression of Change (MPGI), a 1-item questionnaire, to assess the extent to which caregivers perceive the intervention improved functioning and symptoms: "Do you think your ability to manage stress associated with caring for your loved one with dementia is now improved, about the same, or worse, as compared to before your participation in this program?"
Time frame: 0 weeks, 12 weeks, 20 weeks
We will use the PSS-10, to assess perceived stress using a 5-point Likert scale. Scores range from 0 to 40 with higher scores indicating greater stress.
Time frame: 0 weeks, 12 weeks, 20 weeks
This is a 17-item measure (each item is scored on a 0-4 scale) that assesses awareness (items 1-4; scored from 0-16), connection (items 5-10; scored from 0-24), insight (items 11-13; scored from 0-12), and purpose (items 14-17; scored from 0-16). Higher scores indicate greater levels of each sub scale.
Time frame: 0 weeks, 12 weeks, 20 weeks
This measure assesses caregiver burden. We are administering the following sub scales: role entrapment (4 items); role overload (4 items); mastery as a caregiver (4 items); self mastery (4 items); workplace productivity (5 items). Each item is measured on 1-4 point scale. Sub scales with 4 items are scored from 4-16; sub scales with 5 items are scored from 5-20. Higher scores indicate higher levels of each sub scale's construct.
Massachusetts General Hospital
Other
Using Mobile Technology to Reduce Stress in Caregivers of Persons With Dementia. A Scalable Solution to a Growing Problem.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06869993
Behavior, Behavioral Symptoms
Portland, Maine, United States
View Trial DetailsNCT06276023
Alzheimer Disease, Alzheimer's Disease and Related Dementias
Boston, Massachusetts, United States
View Trial DetailsNCT06509100
Behavior, Behavioral Symptoms
Chapel Hill, North Carolina, United States
View Trial DetailsNCT07225907
Autism Spectrum Disorder, Behavior
Charleston, South Carolina, United States
View Trial Details