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NCT05253443 · ClinicalTrials.gov registry record · NA
Mobile App Psychological Interventions for Family Dementia Caregivers
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 135
- Enrollment target
NCT05253443: Completed NA study, sponsored by Massachusetts General Hospital.
NCT05253443 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 135 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05253443, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 135 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BEHAVIORAL Mentalizing Imagery Therapy and caregiver skills mobile application
- BEHAVIORAL Caregiver skills mobile application
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2024-01-05 |
| Est. Completion | 2025-02-15 |
| Phase | NA |
What the finished NCT05253443 record still lists
NCT05253443 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Mentalizing Imagery Therapy and caregiver skills mobile application is the first listed.
NCT05253443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05253443 about?
NCT05253443 is a clinical study titled "Mobile App Psychological Interventions for Family Dementia Caregivers". 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 a...
What is the current status of trial NCT05253443?
This trial is currently completed. It is a NA study. The enrollment target is 135 participants. The study started on 2024-01-05. Estimated completion is 2025-02-15.
What interventions are being tested in trial NCT05253443?
The interventions under investigation include: Mentalizing Imagery Therapy and caregiver skills mobile application (BEHAVIORAL), Caregiver skills mobile application (BEHAVIORAL).
Who is sponsoring clinical trial NCT05253443?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05253443's enrollment target sits among peer trials
135 726th of 2000 higher than 1,273 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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