Family CaregiversNCT05253443
Mobile App Psychological Interventions for Family Dementia Caregivers
A study testing Mentalizing Imagery Therapy and caregiver skills mobile application and Caregiver skills mobile application in people with Family Caregivers, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Family caregivers of persons with dementia often experience chronic stress and insomnia, resulting in decreased mental and physical health. Accessibility of in-person stress reduction therapy is limited due to caregiver time constraints and distance from therapy sites. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Caregivers
- What is being tested?
- Mentalizing Imagery Therapy and caregiver skills mobile application and Caregiver skills mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary caregiver for a relative with dementia (self-identified)
- Age ≥ 50 years*
- Must carry and use a smartphone on a regular basis (at least 5 days per week)
- Fluent in the English language
Who cannot join
- Active psychosis or mania
- Suicide attempt in the past 6 months or current suicidal intent
- Cognitive impairment (Mini Mental Status Examination < 26 (48))
- Unstable medical illness or planned major surgery
- Substance use disorder in the past six months
- Mindfulness or guided imagery practice more than once per week in the past three months
- After the first 60 participants had been recruited for the study, it was determined that goals for a representative racial and ethnic sample had not been met. We therefore sought and received approval from NIH to lower the eligibility age to 50 and over.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Mobile App Delivered Mentalizing Imagery Therapy to Augment Remote Family Dementia Caregiver Skills Training: a Pilot Randomized, Controlled Trial With Outcomes Assessment Using Digital Phenotyping
Family caregivers of persons with dementia often experience chronic stress and insomnia, resulting in decreased mental and physical health. Accessibility of in-person stress reduction therapy is limited due to caregiver time constraints and distance from therapy sites. The goal of this study is to address gaps in the literature regarding smartphone delivery of Mentalizing Imagery Therapy to older adult caregivers. Mentalizing Imagery Therapy (MIT) provides mindfulness and guided imagery tools to reduce stress, promote self and other understanding, and increase feelings of interconnectedness. This study aims to determine the clinical effects of App-delivered caregiver skills with MIT (experimental condition) or without MIT (control condition) on caregivers' perceived stress (primary outcome), as well as develop digital phenotypes of participant behaviors that are associated with clinical/psychological outcomes. Hypotheses include the following: at the 8 week timepoint, caregivers receiving MIT+CS-App will exhibit superiority on psychological outcome measures relative to those receiving CS-App alone (perceived stress being the primary outcome), that overall app usage will mediate improvements in perceived stress, and that the beneficial effects of the MIT+CS-App will remain significant at the 24-week follow-up.
Read the detailed description
According to the World Health Organization, more than 50 million people have Alzheimer's disease (AD) and AD-related disorders (AD/ADRD), with most individuals receiving care from their family members. The stress and burden of caregiving negatively affects caregivers' mental health, with a high proportion reporting elevated levels of depression, insomnia, stress, poorer cognitive outcomes, and anxiety. To promote caregiver wellbeing, previous research has focused on providing skills for behavioral management of the person living with dementia, support and psychoeducational groups to help caregivers learn from each others' experiences, group cognitive behavioral therapy or mindfulness techniques, or combinations of these. A common limitation of most trials of group therapies for family caregivers is that delivery of the intervention occurs in person. In-person delivery requires participant travel, could necessitate costly substitute caregiving, necessitates large resources in terms of meeting space and personnel, and is less acceptable for older adults during the COVID-19 pandemic. In person groups thus suffer from a common drawback of scaling the intervention to assure widespread feasibility and dissemination.
This is a randomized, controlled trial of smartphone App delivered Mentalizing Imagery Therapy (MIT) to augment caregiver skills training. MIT is a "second generation" mindfulness therapy, which couples mindful practice to reduce emotional arousal with psychological principles designed to balance mentalizing. Mindfulness refers to non-judgmental, present focused attention and has been found to reduce depressive and anxious symptoms in community and clinical populations. In MIT, mindfulness is instantiated in gentle stretching and meditative exercises. Mentalizing refers to understanding the mental processes of self and others, and their links to observable behaviors within complex interpersonal situations. In MIT, guided imagery exercises consist of participants imagining their own and others' perspectives and reactions, and the connectedness between self and other. Pilot studies have utilized 4-week group MIT for family AD/ADRD caregivers and found promising benefits for alleviating psychological symptoms of caregiver depression and anxiety, increasing perceived mental well-being and relationship quality. Smartphone delivery of MIT has been shown to be acceptable for family dementia caregivers in a feasibility trial. By increasing mentalizing while providing caregiver skills, the experimental intervention could result in synergism that enables the caregiver to better implement caregiving skills in their unique interpersonal context.
- Conditions
- Family Caregivers
- Being tested
- Mentalizing Imagery Therapy and caregiver skills mobile application, Caregiver skills mobile application
- Keywords
- Caregivers, Stress, Caregiver burden, Insomnia, Mindfulness, Mentalizing Imagery Therapy, Digital phenotyping, mHealth, Smartphones
- Medical subject headings
- Caregiver Burden, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalizing Imagery Therapy and caregiver skills mobile applicationBehavioural
8-week long mobile application intervention course including caregiver skills training and Mentalizing Imagery Therapy techniques with optional weekly group meetings.
Caregiver skills mobile applicationBehavioural
8-week long mobile application intervention course including caregiver skills training with optional weekly group meetings.
| Study group | Role | What they receive |
|---|---|---|
| Mentalizing Imagery Therapy and caregiver skills mobile application | Experimental | Not described Receives: Behavioral: Mentalizing Imagery Therapy and caregiver skills mobile application |
| Caregiver skills mobile application | Active comparator | Not described Receives: Behavioral: Caregiver skills mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS)
The PSS is a 14-item self-report questionnaire that measures the magnitude to which various situations in an individual's life are appraised as stressful. Each item is anchored by a 5-point Likert scale, ranging from 0 = never to 4 = very often. The range of possible scores is 0 to 56, with higher scores indicating worse perceived stress.
Measured: 8-weeks
Secondary outcomes (4)
Zarit Caregiver Burden Scale (CBS)
The CBS is a 22-item self-report assessment that measures the burden a caregiver feels. Each item is anchored on a 5-point Likert scale, ranging from 0 = never to 4 = nearly always. The range of possible scores is 0 to 88, with higher scores indicating more caregiver burden.
Measured: 8-weeks
Caregiver Mastery Index (CMI)
The CMI is a 6-item self-report scale, in which a caregiver measures their level of perceived mastery when providing care. Each item is rated on a 5-point scale from 0 = never to 4 = nearly always. Scores are calculated by reversing the three negatively scored items and summing to generate a total score, with higher scores indicating greater mastery. The range of possible scores is 0 to 24, with higher scores indicating greater caregiver mastery.
Measured: 8-weeks
Insomnia Severity Index (ISI)
The ISI is a 7-item self-report measure that yields the degree to which one is suffering from insomnia. Each item is anchored on a 5-point scale, with higher scores indicating greater symptoms. The range of possible scores is 0 to 28, with higher scores indicating worse insomnia.
Measured: 8-weeks
Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR)
The QIDS-SR is comprised of 16-items, and analyzes the severity of depressive symptoms. Each item is anchored on a 4-point scale from 0 to 3. The total composite score assesses the maximum score for each of the nine cardinal symptoms of major depressive disorder, with the range of possible scores being 0 to 27 and higher scores indicating greater depressive symptom severity.
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start5 Jan 2024
- Primary completion30 Oct 2024
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Family CaregiversStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Felipe A Jain, Massachusetts General Hospital
- Investigators
- Felipe A Jain, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253443
- Sponsor's protocol ID
- 2020P001319
- Other IDs
- K76AG064390
- Status last verified
- May 2025
- First submitted
- 14 Feb 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical trial data will be shared by depositing these data at the National Archive of Computerized Data on Aging (NACDA) which is an NIH-funded repository. De-identified data will be deposited for sharing, which includes demographics, diagnosis, longitudinal symptoms, and digital phenotyping data consistent with applicable laws and regulations. Data documentation will include metadata and will be submitted in comma spaced value format with a codebook. Submitted data will confirm with relevant data and terminology standards. Personally identifying information (such as name, address, date of birth, phone number) will be removed according to HIPAA guidance. All personally identifying information will remain on an AES-256 encrypted server, to which only the principal investigator and authorized study staff have access, in compliance with policies of the Massachusetts General Hospital.
Publications
Jain FA, Chernyak S, Nickerson L, Abrams M, Iacoboni M, Christov-Moore L, Connolly CG, Fisher LB, Sakurai H, Bentley K, Tan E, Pittman M, Lavretsky H, Leuchter AF. Mentalizing imagery therapy for depressed family dementia caregivers: Feasibility, clinical outcomes and brain connectivity changes. J Affect Disord Rep. 2021 Jul;5:100155. doi: 10.1016/j.jadr.2021.100155. Epub 2021 May 29.
PubMed 34498016Sikder AT, Yang FC, Schafer R, Dowling GA, Traeger L, Jain FA. Mentalizing Imagery Therapy Mobile App to Enhance the Mood of Family Dementia Caregivers: Feasibility and Limited Efficacy Testing. JMIR Aging. 2019 Mar 21;2(1):e12850. doi: 10.2196/12850.
PubMed 31518275
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile App Delivered Mentalizing Imagery Therapy to Augment Remote Family Dementia Caregiver Skills Training: a Pilot Randomized, Controlled Trial With Outcomes Assessment Using Digital Phenotyping
- ClinicalTrials.gov ID
- NCT05253443
- Acronym / sponsor ID
- 2020P001319
- Conditions
- Family Caregivers
- Keywords
- Caregivers, Stress, Caregiver burden, Insomnia, Mindfulness, Mentalizing Imagery Therapy, Digital phenotyping, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Family caregivers of persons with dementia often experience chronic stress and insomnia, resulting in decreased mental and physical health. Accessibility of in-person stress reduction therapy is limited due to caregiver time constraints and distance from therapy sites. The goal of this study is to address gaps in the literature regarding smartphone delivery of Mentalizing Imagery Therapy to older adult caregivers. Mentalizing Imagery Therapy (MIT) provides mindfulness and guided imagery tools to reduce stress, promote self and other understanding, and increase feelings of interconnectedness. This study aims to determine the clinical effects of App-delivered caregiver skills with MIT (experimental condition) or without MIT (control condition) on caregivers' perceived stress (primary outcome), as well as develop digital phenotypes of participant behaviors that are associated with clinical/psychological outcomes. Hypotheses include the following: at the 8 week timepoint, caregivers receiving MIT+CS-App will exhibit superiority on psychological outcome measures relative to those receiving CS-App alone (perceived stress being the primary outcome), that overall app usage will mediate improvements in perceived stress, and that the beneficial effects of the MIT+CS-App will remain significant at the 24-week follow-up.
Detailed description
According to the World Health Organization, more than 50 million people have Alzheimer's disease (AD) and AD-related disorders (AD/ADRD), with most individuals receiving care from their family members. The stress and burden of caregiving negatively affects caregivers' mental health, with a high proportion reporting elevated levels of depression, insomnia, stress, poorer cognitive outcomes, and anxiety. To promote caregiver wellbeing, previous research has focused on providing skills for behavioral management of the person living with dementia, support and psychoeducational groups to help caregivers learn from each others' experiences, group cognitive behavioral therapy or mindfulness techniques, or combinations of these. A common limitation of most trials of group therapies for family caregivers is that delivery of the intervention occurs in person. In-person delivery requires participant travel, could necessitate costly substitute caregiving, necessitates large resources in terms of meeting space and personnel, and is less acceptable for older adults during the COVID-19 pandemic. In person groups thus suffer from a common drawback of scaling the intervention to assure widespread feasibility and dissemination.
This is a randomized, controlled trial of smartphone App delivered Mentalizing Imagery Therapy (MIT) to augment caregiver skills training. MIT is a "second generation" mindfulness therapy, which couples mindful practice to reduce emotional arousal with psychological principles designed to balance mentalizing. Mindfulness refers to non-judgmental, present focused attention and has been found to reduce depressive and anxious symptoms in community and clinical populations. In MIT, mindfulness is instantiated in gentle stretching and meditative exercises. Mentalizing refers to understanding the mental processes of self and others, and their links to observable behaviors within complex interpersonal situations. In MIT, guided imagery exercises consist of participants imagining their own and others' perspectives and reactions, and the connectedness between self and other. Pilot studies have utilized 4-week group MIT for family AD/ADRD caregivers and found promising benefits for alleviating psychological symptoms of caregiver depression and anxiety, increasing perceived mental well-being and relationship quality. Smartphone delivery of MIT has been shown to be acceptable for family dementia caregivers in a feasibility trial. By increasing mentalizing while providing caregiver skills, the experimental intervention could result in synergism that enables the caregiver to better implement caregiving skills in their unique interpersonal context.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentalizing Imagery Therapy and caregiver skills mobile application | Experimental | Behavioral: Mentalizing Imagery Therapy and caregiver skills mobile application |
| Caregiver skills mobile application | Active comparator | Behavioral: Caregiver skills mobile application |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary caregiver for a relative with dementia (self-identified)
- Age ≥ 50 years*
- Must carry and use a smartphone on a regular basis (at least 5 days per week)
- Fluent in the English language
Key exclusion criteria (7 listed)
- Active psychosis or mania
- Suicide attempt in the past 6 months or current suicidal intent
- Cognitive impairment (Mini Mental Status Examination < 26 (48))
- Unstable medical illness or planned major surgery
- Substance use disorder in the past six months
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 |
|---|---|---|
| Mentalizing Imagery Therapy and caregiver skills mobile application8-week long mobile application intervention course including caregiver skills training and Mentalizing Imagery Therapy techniques with optional weekly group meetings. | Behavioural | Mentalizing Imagery Therapy and caregiver skills mobile application |
| Caregiver skills mobile application8-week long mobile application intervention course including caregiver skills training with optional weekly group meetings. | Behavioural | Caregiver skills mobile application |
Primary outcome
Perceived Stress Scale (PSS)
Time frame: 8-weeks
The PSS is a 14-item self-report questionnaire that measures the magnitude to which various situations in an individual's life are appraised as stressful. Each item is anchored by a 5-point Likert scale, ranging from 0 = never to 4 = very often. The range of possible scores is 0 to 56, with higher scores indicating worse perceived stress.
4 secondary outcomes
Zarit Caregiver Burden Scale (CBS)
Time frame: 8-weeks
Caregiver Mastery Index (CMI)
Time frame: 8-weeks
Insomnia Severity Index (ISI)
Time frame: 8-weeks
Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR)
Time frame: 8-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 34498016Jain FA, Chernyak S, Nickerson L, Abrams M, Iacoboni M, Christov-Moore L, Connolly CG, Fisher LB, Sakurai H, Bentley K, Tan E, Pittman M, Lavretsky H, Leuchter AF. Mentalizing imagery therapy for depressed family dementia caregivers: Feasibility, clinical outcomes and brain connectivity changes. J Affect Disord Rep. 2021 Jul;5:100155. doi: 10.1016/j.jadr.2021.100155. Epub 2021 May 29.
- Background: PubMed 31518275Sikder AT, Yang FC, Schafer R, Dowling GA, Traeger L, Jain FA. Mentalizing Imagery Therapy Mobile App to Enhance the Mood of Family Dementia Caregivers: Feasibility and Limited Efficacy Testing. JMIR Aging. 2019 Mar 21;2(1):e12850. doi: 10.2196/12850.
- Individual participant dataSharing planned: Yes. Clinical trial data will be shared by depositing these data at the National Archive of Computerized Data on Aging (NACDA) which is an NIH-funded repository. De-identified data will be deposited for sharing, which includes demographics, diagnosis, longitudinal symptoms, and digital phenotyping data consistent with applicable laws and regulations. Data documentation will include metadata and will be submitted in comma spaced value format with a codebook. Submitted data will confirm with relevant data and terminology standards. Personally identifying information (such as name, address, date of birth, phone number) will be removed according to HIPAA guidance. All personally identifying information will remain on an AES-256 encrypted server, to which only the principal investigator and authorized study staff have access, in compliance with policies of the Massachusetts General Hospital.
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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.
Felipe A Jain, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentalizing Imagery Therapy and caregiver skills mobile application and Caregiver skills mobile application in people with Family Caregivers, run by Massachusetts General Hospital 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 4 inclusion and 7 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 16 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived Stress Scale (PSS) (time frame: 8-weeks). 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 NCT05253443, which also lists 2 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 16 May 2025.