Mobile App Psychological Interventions for Family Dementia Caregivers
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
2 other identifiers
interventional
135
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2022
CompletedFirst Posted
Study publicly available on registry
February 23, 2022
CompletedStudy Start
First participant enrolled
January 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2025
CompletedMay 16, 2025
May 1, 2025
10 months
February 14, 2022
May 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
8-weeks
Secondary Outcomes (4)
Zarit Caregiver Burden Scale (CBS)
8-weeks
Caregiver Mastery Index (CMI)
8-weeks
Insomnia Severity Index (ISI)
8-weeks
Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR)
8-weeks
Study Arms (2)
Mentalizing Imagery Therapy and caregiver skills mobile application
EXPERIMENTALCaregiver skills mobile application
ACTIVE COMPARATORInterventions
8-week long mobile application intervention course including caregiver skills training and Mentalizing Imagery Therapy techniques with optional weekly group meetings.
8-week long mobile application intervention course including caregiver skills training with optional weekly group meetings.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (2)
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.
PMID: 34498016BACKGROUNDSikder 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.
PMID: 31518275BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felipe A Jain, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 14, 2022
First Posted
February 23, 2022
Study Start
January 5, 2024
Primary Completion
October 30, 2024
Study Completion
February 15, 2025
Last Updated
May 16, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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.
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.