Mobile App Psychological Interventions for Family Dementia Caregivers
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 135 people enrolled
- Started
- 5 Jan 2024
- Ended
- 15 Feb 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Mentalizing Imagery Therapy and caregiver skills mobile application
- Caregiver skills mobile application
- Record updated
- 16 May 2025
Who can take part
- Age
- 50 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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 take part
- 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
- Cognitive impairment (Mini Mental Status Examination < 26 (48))
- Unstable medical illness or planned major surgery
- Substance use disorder in the past six months
- Active psychosis or mania
- Suicide attempt in the past 6 months or current suicidal intent
Where in United States
- Massachusetts General HospitalBoston, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Mentalizing Imagery Therapy and caregiver skills mobile applicationTreatment being tested
- Caregiver skills mobile applicationExisting treatment, for comparison
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 16 May 2025