Promoting Resilience in Stress Management (PRISM) and Clinical-focused Narrative (CFN) Pilot in Adults With Primary Mitochondrial Disease (PMD).
NCT ID: NCT06051448
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
16 participants
INTERVENTIONAL
2023-09-22
2024-02-28
Brief Summary
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Detailed Description
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Participants will join six virtual study visits. They will be assigned to the PRISM group or the CFN group. During the first study visit, participants will learn about the study and will fill out consent forms if they want to participate. In the next four visits, participants will receive one of the study interventions (PRISM or CFN). Some interventions will be supported with a digital app for participants to track progress and review what was talked about in the intervention. The sixth virtual study visit will be a discussion group that happens a couple months after participants finish the intervention.
Participants will also be sent several surveys to complete. One set of surveys is sent just once after the participant enrolls in the study. Another set of surveys is sent after the participant enrolls and again after the participant finishes the interventions.
The study team will review participants' medical records to confirm they have primary mitochondrial disease and to review the genetic diagnosis. If participants do not have copies of their own medical records or if the study team does not already have access to them, the study team will ask participants to sign a release form to obtain a copy of the medical records and/or genetic testing report.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Promoting Resilience in Stress Management (PRISM)
Promoting Resilience in Stress Management (PRISM)
This program teaches the four pillars of resilience (stress management, goal setting, cognitive restructuring, and benefit-finding) in a one-on-one training program consisting of four 20-30 minute sessions occurring once weekly.
Clinical-focused narrative (CFN)
Clinical-focused narrative (CFN)
This program consists of questions posed to adults with primary mitochondrial disease at regular mitochondrial medicine center visits. Specific topics will be discussed at each session. This consists four 20-30 minute sessions occurring once weekly.
Interventions
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Promoting Resilience in Stress Management (PRISM)
This program teaches the four pillars of resilience (stress management, goal setting, cognitive restructuring, and benefit-finding) in a one-on-one training program consisting of four 20-30 minute sessions occurring once weekly.
Clinical-focused narrative (CFN)
This program consists of questions posed to adults with primary mitochondrial disease at regular mitochondrial medicine center visits. Specific topics will be discussed at each session. This consists four 20-30 minute sessions occurring once weekly.
Eligibility Criteria
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Inclusion Criteria
2. Capable of giving consent, or there is a legally authorized representative capable of giving consent on the subject behalf and if appropriate, assent.
3. Able to speak and read English
4. Able to participate in Web- and App-based interventions
5. Confirmed molecular diagnosis of primary mitochondrial disease
Exclusion Criteria
18 Years
ALL
No
Sponsors
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North American Mitochondrial Disease Consortium (NAMDC)
UNKNOWN
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Elizabeth M McCormick, MS
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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22-020222
Identifier Type: -
Identifier Source: org_study_id