Alzheimer DiseaseNCT04536701
Learning and Improving Alzheimer's Patient-Caregiver Relationships Via Smart Healthcare Technology
A study testing Mood Monitoring and Behavioral Recommendation System in people with Alzheimer Disease and Caregiver Stress Syndrome, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this project is to develop a monitoring, modeling, and interactive recommendation solution (for caregivers) for in-home dementia patient care that focuses on caregiver-patient relationships. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Caregiver Stress Syndrome
- What is being tested?
- Mood Monitoring and Behavioral Recommendation System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females and males
- Age 60-90 years
- Physician documentation of dementia: Alzheimer's disease, vascular, mixed or unspecified type
- Community-dwelling (living in the home)
- Fluent in English
- Age 21 years or older
Show all 10Show fewer
- Informal, unpaid caregiver who resides with the care recipient
- Fluent in English
- Functioning home Wifi
- Scoring above a 3 on the Revised Memory and Behavior Problems Checklist, a clinical cut-off point used to determine caregiver stress.
Who cannot join
- Presence of acute illness as this could lead to delirium
- Alcohol abuse or dependence within the past 2 years (DSM-IV criteria)
- History of significant psychiatric illness (e.g., schizophrenia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collaborative Research: Learning and Improving Alzheimer's Patient-Caregiver Relationships Via Smart Healthcare Technology
The purpose of this project is to develop a monitoring, modeling, and interactive recommendation solution (for caregivers) for in-home dementia patient care that focuses on caregiver-patient relationships. This includes monitoring for mood and stress and analyzing the significance of monitoring those attributes to dementia patient care and subsequent behavior dynamics between the patient and caregiver. In addition, novel and adaptive behavioral suggestions at the right moments aims at helping improve familial interactions related to caregiving, which over time should ameliorate the stressful effects of the patient's illness and reduce strain on caregivers. The technical solution consists of a core set of statistical learning based techniques for automated generation of specialized modules required by in-home dementia patient care. There are three main technical components in the solution. The first obtains textual content and prosody from voice and uses advanced machine learning techniques to create classification models. This approach not only monitors patients' behavior, but also caregivers', and infers the underlying dynamics of their interactions, such as changes in mood and stress. The second is the automated creation of classifiers and inference modules tailored to the particular patients and dementia conditions (such as different stages of dementia). The third is an adaptive recommendation system that closes the loop of an in-home behavior monitoring system.
Read the detailed description
The purpose of this project is to develop a monitoring, modeling, and interactive recommendation solution (for caregivers) for in-home dementia patient care that focuses on caregiver-patient relationships. This includes monitoring for mood and stress and analyzing the significance of monitoring those attributes to dementia patient care and subsequent behavior dynamics between the patient and caregiver. In addition, novel and adaptive behavioral suggestions will be provided to family caregivers via text messages on project Smart phones at the right moments aimed to help improve familial interactions related to caregiving, which over time should ameliorate the stressful effects of the patient's illness and reduce strain on caregivers. The technical solution consists of a core set of statistical learning based techniques for automated generation of specialized modules required by in-home dementia patient care. There are three main technical components in the solution. - The first obtains textual content and prosody from voice and uses advanced machine learning techniques to create classification models. This approach not only monitors patients' behavior, but also caregivers', and infers the underlying dynamics of their interactions, such as changes in mood and stress. - The second is the automated creation of classifiers and inference modules tailored to the particular patients and dementia conditions (such as different stages of dementia). - The third is an adaptive recommendation system that closes the loop of an in-home behavior monitoring system.
- Conditions
- Alzheimer Disease, Caregiver Stress Syndrome
- Being tested
- Mood Monitoring and Behavioral Recommendation System
- Keywords
- Alzheimer Disease, Dementia, Caregiving, Smart Health Technology
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mood Monitoring and Behavioral Recommendation SystemBehavioural
The purpose of this project is to develop a monitoring, modeling, and interactive recommendation solution (for caregivers) for in-home dementia patient care that focuses on caregiver-patient relationships. This includes monitoring for mood and stress and analyzing the significance of monitoring those attributes to dementia patient care and subsequent behavior dynamics between the patient and caregiver. In addition, novel and adaptive behavioral suggestions will be provided to family caregivers via text messages on project Smart phones at the right moments aimed to help improve familial interactions related to caregiving, which over time should ameliorate the stressful effects of the patient's illness and reduce strain on caregivers.
| Study group | Role | What they receive |
|---|---|---|
| Dementia/Caregiver Dyad | Experimental | All dementia/caregiver dyads will have in-home acoustic monitoring to classify mood and will be provided mindfulness-based stress reduction recommendations via a smart phone. Receives: Behavioral: Mood Monitoring and Behavioral Recommendation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety Stress Scale (DASS)
The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress in 3 subscales of 14 items each. The scores of each subscale range from 0-42. These subscales are scored by the addition of the total item scores. Total score is obtained by summing all subscores. Total minimum score: 0; Total maximum score: 126; A higher score indicates higher levels of emotional distress, depression, anxiety and stress.
Total: Normal - 0-32; Mild - 33-39; Moderate - 40-49; Severe - 50-57; Extremely severe - 58+
Depression: Normal - 0-9; Mild -10-12; Moderate -13-20; Severe - 21-27; Extremely severe - 28-42
Anxiety: Normal - 0-6; Mild - 7-9; Moderate -10-14; Severe -15-19; Extremely severe - 20-42
Stress: Normal - 0-10; Mild - 11-18; Moderate -19-26; Severe - 27-34; Extremely severe - 35-42
Measured: Baseline, 4 months
Revised Memory and Behavior Problems Checklist (RMBPC)
RMBPC 24-item, caregiver-report of observable behavioral problems in dementia patients AND the caregiver's stress reactions to these disturbances. It provides a total score and 3 subscale scores (memory, depression, and disruptive behaviors) and scores for caregiver reactions.
Score ranges - Frequency: Total 0-96; Disruptive 0-32; Depressive 0-36; Memory 0-24. Sum items with scores of 0 to 4 on subscales and total. If question score is 9, exclude it from the sum and item count. Sum items for each subscale, compute the mean item score for each subscale by dividing by the number of items included in the sum.
Score ranges - Reaction Total 1-96; Disruptive 1-36; Depressive 1-36; Memory 1-24. Include only items with frequency scores of 1 to 4 in the reaction scoring. Compute the mean reaction score by summing reaction scores of these items and then dividing by the number of items included in the sum. A higher score indicates worse outcomes.
Measured: Baseline, 4 months
Change in Caregiver Emotional Reactivity
The 16-item, Difficulties in Emotion Regulation Scale (DERS-16) will be used to measure caregivers' ability to regulate emotions at baseline and end of study. The scale used is the brief version of a theoretically-driven, valid, and reliable self-report tool used to measure difficulties with emotion regulation. The brief version will be more easily administered with the study population and has been shown to be valid and reliable [41]. Minimum score: 16; Maximum score: 80. A higher score indicates higher levels of caregiver emotional reactivity.
Measured: Baseline, 4 months
Five Facet Mindfulness Questionnaire
Five Facet Mindfulness Questionnaire 39-item to measure capacity for five different domains of mindfulness practice at baseline and end of study. The five facets include non-reactivity to the inner experience, non-judgment of the inner experience, acting with awareness, observing, and describing internal states. All items are scored with a scale of 1-5. Some items are marked to be reverse scored. All items are scored and summed then divided by the total in each category by the number of items in that category to get an average category score. Each category is summed to calculate the Total then divided by the number of items to get an average item score for each subscale. A higher score indicates higher levels of caregiver capacity for mindfulness practices and better outcomes.
Score ranges: Total 1-5; Observing 1-5; Describing 1- 5; Acting with Awareness 1-5; Non-judging 1-5; Nonreactivity 1-5
Measured: Baseline, 4 months
Change in Caregiver Strain
Modified Caregiver Strain Index (MCSI): It is a 13-item self-report measure that examines both subjective and objective elements of caregiver strain. The MCSI showed excellent inter-item and test-retest reliability and was correlated in expected directions with relevant criteria [32]. It has excellent reliability and validity, displays adequate clinical sensitivity, has an established cut-off for determining functional/dysfunctional systems, and has been used successfully on a variety of mental health outcomes [28]. We will use a practice tracking worksheet to assess how much the caregivers practice the exercises over the course of the study. Minimum score: 0; Maximum score: 26. High scores indicates higher caregiver strain.
Measured: Baseline, 4 months
Family Assessment Device (FAD)
The FAD is a self-report measure that is given as a set of seven subscales measuring a different dimension of family function. Scores for each dimension (problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, and general functioning) are calculated separately as the mean of the items in that subscale. Scored by summing the endorsed responses (1-4) for each subscale (negatively worded statements are reversed) and dividing by the number of items in each scale. A higher score indicates greater levels of family functioning on all subscales
Score Ranges: Total 1-4; Problem Solving 1-5; Communication 1-4; Roles 1-4; Affective Responsiveness 1-6; Affective Involvement 1-7; Behavior Control 1-4; General Functioning 1-4
Measured: Baseline, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start19 Feb 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal descriptive
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, The University of Tennessee, Knoxville
- Responsible party
- Principal investigator, Karen Rose, Ohio State University
- Investigators
- Karen M Rose, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536701
- Sponsor's protocol ID
- 2019B0406
- Status last verified
- Apr 2025
- First submitted
- 19 Aug 2020
- Last updated
- 6 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ko E, Rose KM, Gordon KC, Kim S, Gao Y, Wang P, Wijayasingha L, Wang H, Stankovic JA, Wright KD. Feasibility and Acceptability of the Smarthealth Intervention for Dementia Caregivers. A Qualitative Analysis of a Single-Group Pilot Study. J Adv Nurs. 2026 Apr;82(4):3891-3905. doi: 10.1111/jan.70007. Epub 2025 Jun 26.
PubMed 40566925Ko E, Gao Y, Wang P, Wijayasingha L, Wright KD, Gordon KC, Wang H, Stankovic JA, Rose KM. Recruitment Challenges and Strategies in a Technology-Based Intervention for Dementia Caregivers: Descriptive Study. JMIR Form Res. 2025 Jan 17;9:e59291. doi: 10.2196/59291.
PubMed 39864818Rose KM, Coop Gordon K, Schlegel EC, Mccall M, Gao Y, Ma M, Lenger KA, Ko E, Wright KD, Wang H, Stankovic J. Smarthealth technology study protocol to improve relationships between older adults with dementia and family caregivers. J Adv Nurs. 2021 May;77(5):2519-2529. doi: 10.1111/jan.14714. Epub 2021 Feb 11.
PubMed 33576064
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Research: Learning and Improving Alzheimer's Patient-Caregiver Relationships Via Smart Healthcare Technology
- ClinicalTrials.gov ID
- NCT04536701
- Acronym / sponsor ID
- 2019B0406
- Conditions
- Alzheimer Disease, Caregiver Stress Syndrome
- Keywords
- Alzheimer Disease, Dementia, Caregiving, Smart Health Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Virginia, The University of Tennessee, Knoxville
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to develop a monitoring, modeling, and interactive recommendation solution (for caregivers) for in-home dementia patient care that focuses on caregiver-patient relationships. This includes monitoring for mood and stress and analyzing the significance of monitoring those attributes to dementia patient care and subsequent behavior dynamics between the patient and caregiver. In addition, novel and adaptive behavioral suggestions at the right moments aims at helping improve familial interactions related to caregiving, which over time should ameliorate the stressful effects of the patient's illness and reduce strain on caregivers. The technical solution consists of a core set of statistical learning based techniques for automated generation of specialized modules required by in-home dementia patient care. There are three main technical components in the solution. The first obtains textual content and prosody from voice and uses advanced machine learning techniques to create classification models. This approach not only monitors patients' behavior, but also caregivers', and infers the underlying dynamics of their interactions, such as changes in mood and stress. The second is the automated creation of classifiers and inference modules tailored to the particular patients and dementia conditions (such as different stages of dementia). The third is an adaptive recommendation system that closes the loop of an in-home behavior monitoring system.
Detailed description
The purpose of this project is to develop a monitoring, modeling, and interactive recommendation solution (for caregivers) for in-home dementia patient care that focuses on caregiver-patient relationships. This includes monitoring for mood and stress and analyzing the significance of monitoring those attributes to dementia patient care and subsequent behavior dynamics between the patient and caregiver. In addition, novel and adaptive behavioral suggestions will be provided to family caregivers via text messages on project Smart phones at the right moments aimed to help improve familial interactions related to caregiving, which over time should ameliorate the stressful effects of the patient's illness and reduce strain on caregivers. The technical solution consists of a core set of statistical learning based techniques for automated generation of specialized modules required by in-home dementia patient care. There are three main technical components in the solution. - The first obtains textual content and prosody from voice and uses advanced machine learning techniques to create classification models. This approach not only monitors patients' behavior, but also caregivers', and infers the underlying dynamics of their interactions, such as changes in mood and stress. - The second is the automated creation of classifiers and inference modules tailored to the particular patients and dementia conditions (such as different stages of dementia). - The third is an adaptive recommendation system that closes the loop of an in-home behavior monitoring system.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal descriptive
| Arm | Type | Receives |
|---|---|---|
| Dementia/Caregiver Dyad | Experimental | Behavioral: Mood Monitoring and Behavioral Recommendation SystemAll dementia/caregiver dyads will have in-home acoustic monitoring to classify mood and will be provided mindfulness-based stress reduction recommendations via a smart phone. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Females and males
- Age 60-90 years
- Physician documentation of dementia: Alzheimer's disease, vascular, mixed or unspecified type
- Community-dwelling (living in the home)
- Fluent in English
Key exclusion criteria (3 listed)
- Presence of acute illness as this could lead to delirium
- Alcohol abuse or dependence within the past 2 years (DSM-IV criteria)
- History of significant psychiatric illness (e.g., schizophrenia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mood Monitoring and Behavioral Recommendation SystemThe purpose of this project is to develop a monitoring, modeling, and interactive recommendation solution (for caregivers) for in-home dementia patient care that focuses on caregiver-patient relationships. This includes monitoring for mood and stress and analyzing the significance of monitoring those attributes to dementia patient care and subsequent behavior dynamics between the patient and caregiver. In addition, novel and adaptive behavioral suggestions will be provided to family caregivers via text messages on project Smart phones at the right moments aimed to help improve familial interactions related to caregiving, which over time should ameliorate the stressful effects of the patient's illness and reduce strain on caregivers. | Behavioural | Dementia/Caregiver Dyad |
Primary outcome
Depression Anxiety Stress Scale (DASS)
Time frame: Baseline, 4 months
The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress in 3 subscales of 14 items each. The scores of each subscale range from 0-42. These subscales are scored by the addition of the total item scores. Total score is obtained by summing all subscores. Total minimum score: 0; Total maximum score: 126; A higher score indicates higher levels of emotional distress, depression, anxiety and stress. Total: Normal - 0-32; Mild - 33-39; Moderate - 40-49; Severe - 50-57; Extremely severe - 58+ Depression: Normal - 0-9; Mild -10-12; Moderate -13-20; Severe - 21-27; Extremely severe - 28-42 Anxiety: Normal - 0-6; Mild - 7-9; Moderate -10-14; Severe -15-19; Extremely severe - 20-42 Stress: Normal - 0-10; Mild - 11-18; Moderate -19-26; Severe - 27-34; Extremely severe - 35-42
Revised Memory and Behavior Problems Checklist (RMBPC)
Time frame: Baseline, 4 months
RMBPC 24-item, caregiver-report of observable behavioral problems in dementia patients AND the caregiver's stress reactions to these disturbances. It provides a total score and 3 subscale scores (memory, depression, and disruptive behaviors) and scores for caregiver reactions. Score ranges - Frequency: Total 0-96; Disruptive 0-32; Depressive 0-36; Memory 0-24. Sum items with scores of 0 to 4 on subscales and total. If question score is 9, exclude it from the sum and item count. Sum items for each subscale, compute the mean item score for each subscale by dividing by the number of items included in the sum. Score ranges - Reaction Total 1-96; Disruptive 1-36; Depressive 1-36; Memory 1-24. Include only items with frequency scores of 1 to 4 in the reaction scoring. Compute the mean reaction score by summing reaction scores of these items and then dividing by the number of items included in the sum. A higher score indicates worse outcomes.
Change in Caregiver Emotional Reactivity
Time frame: Baseline, 4 months
The 16-item, Difficulties in Emotion Regulation Scale (DERS-16) will be used to measure caregivers' ability to regulate emotions at baseline and end of study. The scale used is the brief version of a theoretically-driven, valid, and reliable self-report tool used to measure difficulties with emotion regulation. The brief version will be more easily administered with the study population and has been shown to be valid and reliable [41]. Minimum score: 16; Maximum score: 80. A higher score indicates higher levels of caregiver emotional reactivity.
Five Facet Mindfulness Questionnaire
Time frame: Baseline, 4 months
Five Facet Mindfulness Questionnaire 39-item to measure capacity for five different domains of mindfulness practice at baseline and end of study. The five facets include non-reactivity to the inner experience, non-judgment of the inner experience, acting with awareness, observing, and describing internal states. All items are scored with a scale of 1-5. Some items are marked to be reverse scored. All items are scored and summed then divided by the total in each category by the number of items in that category to get an average category score. Each category is summed to calculate the Total then divided by the number of items to get an average item score for each subscale. A higher score indicates higher levels of caregiver capacity for mindfulness practices and better outcomes. Score ranges: Total 1-5; Observing 1-5; Describing 1- 5; Acting with Awareness 1-5; Non-judging 1-5; Nonreactivity 1-5
Change in Caregiver Strain
Time frame: Baseline, 4 months
Modified Caregiver Strain Index (MCSI): It is a 13-item self-report measure that examines both subjective and objective elements of caregiver strain. The MCSI showed excellent inter-item and test-retest reliability and was correlated in expected directions with relevant criteria [32]. It has excellent reliability and validity, displays adequate clinical sensitivity, has an established cut-off for determining functional/dysfunctional systems, and has been used successfully on a variety of mental health outcomes [28]. We will use a practice tracking worksheet to assess how much the caregivers practice the exercises over the course of the study. Minimum score: 0; Maximum score: 26. High scores indicates higher caregiver strain.
Family Assessment Device (FAD)
Time frame: Baseline, 4 months
The FAD is a self-report measure that is given as a set of seven subscales measuring a different dimension of family function. Scores for each dimension (problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, and general functioning) are calculated separately as the mean of the items in that subscale. Scored by summing the endorsed responses (1-4) for each subscale (negatively worded statements are reversed) and dividing by the number of items in each scale. A higher score indicates greater levels of family functioning on all subscales Score Ranges: Total 1-4; Problem Solving 1-5; Communication 1-4; Roles 1-4; Affective Responsiveness 1-6; Affective Involvement 1-7; Behavior Control 1-4; General Functioning 1-4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40566925Ko E, Rose KM, Gordon KC, Kim S, Gao Y, Wang P, Wijayasingha L, Wang H, Stankovic JA, Wright KD. Feasibility and Acceptability of the Smarthealth Intervention for Dementia Caregivers. A Qualitative Analysis of a Single-Group Pilot Study. J Adv Nurs. 2026 Apr;82(4):3891-3905. doi: 10.1111/jan.70007. Epub 2025 Jun 26.
- Derived from this study: PubMed 39864818Ko E, Gao Y, Wang P, Wijayasingha L, Wright KD, Gordon KC, Wang H, Stankovic JA, Rose KM. Recruitment Challenges and Strategies in a Technology-Based Intervention for Dementia Caregivers: Descriptive Study. JMIR Form Res. 2025 Jan 17;9:e59291. doi: 10.2196/59291.
- Derived from this study: PubMed 33576064Rose KM, Coop Gordon K, Schlegel EC, Mccall M, Gao Y, Ma M, Lenger KA, Ko E, Wright KD, Wang H, Stankovic J. Smarthealth technology study protocol to improve relationships between older adults with dementia and family caregivers. J Adv Nurs. 2021 May;77(5):2519-2529. doi: 10.1111/jan.14714. Epub 2021 Feb 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen M Rose, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mood Monitoring and Behavioral Recommendation System in people with Alzheimer Disease and Caregiver Stress Syndrome, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety Stress Scale (DASS) (time frame: Baseline, 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04536701, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.