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Behavioral Intervention

PRISM + CFN for Mitochondrial Disease

Phase 1 & 2
Recruiting
Led By Elizabeth M McCormick, MS
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed molecular diagnosis of primary mitochondrial disease
Be older than 18 years old
Must not have
Suspected but no molecular diagnosis primary mitochondrial disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months after the first intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find the best way to help people with mitochondrial disease cope with stress and become more resilient. It'll test two interventions: PRISM & CFN.

Who is the study for?
This trial is for adults over 18 with a confirmed molecular diagnosis of primary mitochondrial disease who can give consent, speak and read English, and use web and app-based interventions. It's not for those without a confirmed diagnosis.
What is being tested?
The study tests two methods to help patients with mitochondrial disease manage stress: PRISM aims to improve resilience, while CFN focuses on personal clinical narratives as a therapeutic tool.
What are the potential side effects?
Since PRISM and CFN are non-medical interventions focusing on stress management and storytelling respectively, they may have minimal side effects related to emotional discomfort or fatigue from participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a confirmed diagnosis of primary mitochondrial disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am suspected to have a mitochondrial disease but don't have a molecular diagnosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months after the first intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months after the first intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine change in mean in scores on validated scale assessing quality of life between those who receive PRISM and those who receive CFN.
Determine change in mean in scores on validated scale assessing resilience between those who receive PRISM and those who receive CFN.
Determine change in mean scores on validated scale assessing coping between those who receive PRISM and those who receive CFN.
+6 more
Secondary study objectives
Explore participant experience with PRISM and CFN and assess their acceptability among adults with primary mitochondrial disease.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Promoting Resilience in Stress Management (PRISM)Active Control1 Intervention
Group II: Clinical-focused narrative (CFN)Active Control1 Intervention

Find a Location

Who is running the clinical trial?

North American Mitochondrial Disease Consortium (NAMDC)UNKNOWN
Children's Hospital of PhiladelphiaLead Sponsor
729 Previous Clinical Trials
8,469,767 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,377 Previous Clinical Trials
651,812 Total Patients Enrolled
~12 spots leftby Nov 2025
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