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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months after the first intervention

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months after the first intervention

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Explore participant experience with PRISM and CFN and assess their acceptability among adults with primary mitochondrial disease.

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

North American Mitochondrial Disease Consortium (NAMDC)UNKNOWN

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,582,995 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,341 Previous Clinical Trials

649,564 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently open for this trial?

"According to clinicaltrials.gov, this medical experiment is still seeking participants. Initially posted on September 1st 2023 and most recently revised on the 12th of that same month."

Answered by AI

To what extent is the scope of this experiment encompassing participants?

"Affirmative. According to the information on clinicaltrials.gov, enrolment for this medical investigation is still underway as of September 12th 2023. 25 participants are needed from 1 site and the trial was first posted on September 1st 2023."

Answered by AI