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NCT05253443
Mobile App Psychological Interventions for Family Dementia Caregivers
NA trial testing Mentalizing Imagery Therapy and caregiver skills mobile application in Family Caregivers in 135 participants. Completed in 15 February 2025.
30 October 2024
Quick facts
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 135 |
| Start date | 5 January 2024 |
| Primary completion | 30 October 2024 |
| Estimated completion | 15 February 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Mentalizing Imagery Therapy and caregiver skills mobile application
- Caregiver skills mobile application
Conditions studied
- Family Caregivers — all drugs for Family Caregivers →
Sponsor
Massachusetts General Hospital
Who can join
50 and older, any sex, with Family Caregivers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mentalizing imagery therapy to augment skills training for dementia caregivers: Protocol for a randomized, controlled trial of a mobile application and digital phenotyping.
Jain FA, Okereke O, Gitlin L, Pedrelli P, et al · · 2022 · cited 4× · PMID 35331943 · DOI 10.1016/j.cct.2022.106737 -
A state-of-the-art narrative review of peer support for family caregivers of people with dementia: from in-person to digital delivery.
Cui S, Crowe-Cumella H, Fortuna KL, Jain FA. · · 2025 · cited 3× · PMID 39944854 · DOI 10.21037/mhealth-24-19
Verify or expand the search:
- PubMed search for NCT05253443
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT04802720 — A Study Comparing Two Types of Supportive Interventions for Caregivers of Patients With Cancer · NA · active not recruiting
Other Massachusetts General Hospital trials
Trials by the same sponsor.
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- NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
- NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
- NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
- NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05253443 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
- Last refreshed: 16 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05253443.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing