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Promoting Resilience in Stress Management (PRISM) and Clinical-focused Narrative (CFN) Pilot in Adults With Primary Mitochondrial Disease (PMD).

NCT06051448 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-11-29

No results posted yet for this 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.

Conditions

  • Mitochondrial Diseases
  • Mitochondrial Myopathies
  • Mitochondrial Encephalomyopathies
  • MELAS
  • MERRF

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • North American Mitochondrial Disease Consortium (NAMDC)

    collaborator UNKNOWN

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Children's Hospital of Philadelphia

    lead OTHER

Principal Investigators

  • Elizabeth M McCormick, MS · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2024-02-28
Completion
2024-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06051448 on ClinicalTrials.gov