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NCT06051448 · ClinicalTrials.gov registry record · Phase 1
Promoting Resilience in Stress Management (PRISM) and Clinical-focused Narrative (CFN) Pilot in Adults With Primary Mitochondrial Disease (PMD).
A Phase 1 study of Mitochondrial Diseases and MItochondrial Myopathies, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT06051448: Completed Phase 1 study of Mitochondrial Diseases and MItochondrial Myopathies, sponsored by Children's Hospital of Philadelphia.
NCT06051448 is a Phase 1 study of Mitochondrial Diseases and MItochondrial Myopathies that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 16 participants, below the 274-participant average among 7 other Mitochondrial Diseases trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06051448, a Phase 1 study of Mitochondrial Diseases and MItochondrial Myopathies, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to find the best way to help people with primary mitochondrial disease deal with the stress of their condition, and to help these people be better able to "bounce back," or be resilient. In order to do this, the investigators are going to test two interventions (an intervention means that it aims to change something): Promoting Resilience in Stress Management (PRISM) and clinical-focused narrative (CFN) intervention.
Primary Outcome
The Connor-Davidson Resilience Scale (CD-RISC) is a validated measure to assess resilience. Possible scores range from 0-100 (higher scores reflecting greater resilience). Mean scores will be calculated on scales administered to subjects before the intervention and scales administered after intervention completion.
Conditions Studied
Interventions
- BEHAVIORAL Promoting Resilience in Stress Management (PRISM)
- BEHAVIORAL Clinical-focused narrative (CFN)
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-09-22 |
| Est. Completion | 2024-02-28 |
| Phase | Phase 1 |
What the finished NCT06051448 record still lists
NCT06051448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 274-participant average among 7 other Mitochondrial Diseases trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Mitochondrial Diseases appearing as the primary indexed condition, and to 2 interventions - of which Promoting Resilience in Stress Management (PRISM) is the first listed.
NCT06051448 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06051448 about?
NCT06051448 is a clinical study titled "Promoting Resilience in Stress Management (PRISM) and Clinical-focused Narrative (CFN) Pilot in Adults With Primary Mitochondrial Disease (PMD).". The goal of this study is to find the best way to help people with primary mitochondrial disease deal with the stress of their condition, and to help these people be better able to "bounce back," or be resilient. In order to do this, the investigators are going to test two interventions (an interven...
What is the current status of trial NCT06051448?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2023-09-22. Estimated completion is 2024-02-28.
What conditions does trial NCT06051448 study?
This clinical trial studies the following conditions: Mitochondrial Diseases, MItochondrial Myopathies, Mitochondrial Encephalomyopathies, MELAS, MERRF.
What interventions are being tested in trial NCT06051448?
The interventions under investigation include: Promoting Resilience in Stress Management (PRISM) (BEHAVIORAL), Clinical-focused narrative (CFN) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06051448?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06051448 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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