Clinical trial NCT06051448: Promoting Resilience in Stress Management (PRISM) and Clinical-focused Narrative (CFN) Pilot in Adults With Primary Mitochondrial Disease (PMD).
Official title: Harnessing Resilience in Adults With Primary Mitochondrial Disease: A Pilot Study Investigating the Feasibility of the Promoting Resilience in Stress Management (PRISM) and Clinical-focused Narrative (CFN) Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mitochondrial Diseases
Mitochondrial Myopathies
Mitochondrial Encephalomyopathies
MELAS
MERRF
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: North American Mitochondrial Disease Consortium (NAMDC)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-09-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The investigators are going to test two interventions in this pilot study. The first is called Promoting Resilience in Stress Management (PRISM). The second is called clinical-focused narrative (CFN) intervention. These interventions involve talking with the researcher about several specific topics.

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.

Eligibility criteria: Inclusion Criteria:

1. Males or females at least 18 years old
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:

1. Suspected but no molecular diagnosis primary mitochondrial disease

Primary outcomes:
measure: Determine mean score on validated scale assessing resilience in those who receive PRISM and those who receive CFN.
timeFrame: Up to 3 months after the first intervention
measure: Determine change in mean in scores on validated scale assessing resilience between those who receive PRISM and those who receive CFN.
timeFrame: Up to 3 months after the first intervention
measure: Determine variability in scores on validated scale assessing resilience between those who receive PRISM and those who receive CFN.
timeFrame: Up to 3 months after the first intervention
measure: Determine mean scores on validated scale assessing coping in those who receive PRISM and those who receive CFN.
timeFrame: Up to 3 months after the first intervention
measure: Determine change in mean scores on validated scale assessing coping between those who receive PRISM and those who receive CFN.
timeFrame: Up to 3 months after the first intervention
measure: Determine variability in scores on a validated scale assessing coping between those who receive PRISM and those who receive CFN.
timeFrame: Up to 3 months after the first intervention
measure: Determine mean scores on validated scale assessing quality of life in those who receive PRISM and those who receive CFN.
timeFrame: Up to 3 months after the first intervention
measure: Determine change in mean in scores on validated scale assessing quality of life between those who receive PRISM and those who receive CFN.
timeFrame: Up to 3 months after the first intervention
measure: Determine variability in scores on a validated scale assessing quality of life between those who receive PRISM and those who receive CFN.
timeFrame: Up to 3 months after the first intervention
Secondary outcomes:
measure: Explore participant experience with PRISM and CFN and assess their acceptability among adults with primary mitochondrial disease.
timeFrame: Three months after completing the intervention, discussion groups will occur.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Elizabeth M McCormick, MS
role: PRINCIPAL_INVESTIGATOR
References: