Mobile App Psychological Interventions for Family Dementia Caregivers
Primary Purpose
Family Caregivers
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mentalizing Imagery Therapy and caregiver skills mobile application
Caregiver skills mobile application
Sponsored by
About this trial
This is an interventional treatment trial for Family Caregivers focused on measuring Caregivers, Stress, Caregiver burden, Insomnia, Mindfulness, Mentalizing Imagery Therapy, Digital phenotyping, mHealth, Smartphones
Eligibility Criteria
Inclusion Criteria:
- Primary caregiver for a relative with dementia (self-identified)
- Age ≥ 60 years
- Must carry and use a smartphone on a regular basis (at least 5 days per week)
- Fluent in the English language
Exclusion Criteria:
- 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
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mentalizing Imagery Therapy and caregiver skills mobile application
Caregiver skills mobile application
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05253443
First Posted
February 14, 2022
Last Updated
October 18, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05253443
Brief Title
Mobile App Psychological Interventions for Family Dementia Caregivers
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Family Caregivers
Keywords
Caregivers, Stress, Caregiver burden, Insomnia, Mindfulness, Mentalizing Imagery Therapy, Digital phenotyping, mHealth, Smartphones
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mentalizing Imagery Therapy and caregiver skills mobile application
Arm Type
Experimental
Arm Title
Caregiver skills mobile application
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mentalizing Imagery Therapy and caregiver skills mobile application
Intervention Description
8-week long mobile application intervention course including caregiver skills training and Mentalizing Imagery Therapy techniques with optional weekly group meetings.
Intervention Type
Behavioral
Intervention Name(s)
Caregiver skills mobile application
Intervention Description
8-week long mobile application intervention course including caregiver skills training with optional weekly group meetings.
Primary Outcome Measure Information:
Title
Perceived Stress Scale (PSS)
Description
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.
Time Frame
8-weeks
Secondary Outcome Measure Information:
Title
Zarit Caregiver Burden Scale (CBS)
Description
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.
Time Frame
8-weeks
Title
Caregiver Mastery Index (CMI)
Description
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.
Time Frame
8-weeks
Title
Insomnia Severity Index (ISI)
Description
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.
Time Frame
8-weeks
Title
Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR)
Description
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.
Time Frame
8-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Primary caregiver for a relative with dementia (self-identified)
Age ≥ 60 years
Must carry and use a smartphone on a regular basis (at least 5 days per week)
Fluent in the English language
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felipe A Jain, MD
Phone
6176434682
Email
felipe.jain@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe A Jain, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulina Gutierrez-Ramirez
Email
pgutierrez-ramirez@mgh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The clinical trial data will be deposited into the repository as soon as possible but no later than within one year of the completion of the funded project period for the parent award or upon acceptance of the data for online publication, or public disclosure of a submitted patent application, whichever is earlier.
IPD Sharing Access Criteria
Data will be deposited and made available through NACDA which is an NIH-funded repository, and these data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes such as identifying predictors of clinical trial outcomes. The names and Institutions of persons either given or denied access to the data, and the bases for such decisions, will be summarized in the annual progress report.
NACDA has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.
Citations:
PubMed Identifier
34498016
Citation
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.
Results Reference
background
PubMed Identifier
31518275
Citation
Sikder 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.
Results Reference
background
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Mobile App Psychological Interventions for Family Dementia Caregivers
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