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

NCT06051448 | Completed Phase 1 DMC

• 2 other identifiers: 22-020222U54NS078059-12
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitochondrial Diseases; Mitochondrial Myopathies; Mitochondrial Encephalomyopathies; MELAS; MERRF

Outcome Measures

Primary Outcomes (9)

• Determine mean score on validated scale assessing resilience in those who receive PRISM and those who receive CFN.

  The Connor-Davidson Resilience Scale (CD-RISC) is a validated measure to assess resilience. Possible scores range from 0-100 (higher scores reflecting greater resilience). Mean scores will be calculated on scales administered to subjects before the intervention and scales administered after intervention completion.

  Up to 3 months after the first intervention

• Determine change in mean in scores on validated scale assessing resilience between those who receive PRISM and those who receive CFN.

  The Connor-Davidson Resilience Scale (CD-RISC) is a validated measure to assess resilience. Possible scores range from 0-100 (higher scores reflecting greater resilience). Mean scores calculated on scales administered before the intervention will be compared to mean scores on scales administered after completion of the intervention.

  Up to 3 months after the first intervention

• Determine variability in scores on validated scale assessing resilience between those who receive PRISM and those who receive CFN.

  The Connor-Davidson Resilience Scale (CD-RISC) is a validated measure to assess resilience. Possible scores range from 0-100 (higher scores reflecting greater resilience). Variability in scores of scales collected before starting and after completion of the interventions will be calculated.

  Up to 3 months after the first intervention

• Determine mean scores on validated scale assessing coping in those who receive PRISM and those who receive CFN.

  The Family Crisis Oriented Personal Scale (F-COPES) is a validated measure to assess coping. Possible scores range from 30 to 150 (higher scores reflect higher levels of coping and problem-solving ability). Mean scores will be calculated on scales administered to subjects before the intervention and scales administered after intervention completion.

  Up to 3 months after the first intervention

• Determine change in mean scores on validated scale assessing coping between those who receive PRISM and those who receive CFN.

  The Family Crisis Oriented Personal Scale (F-COPES) is a validated measure to assess coping. Possible scores range from 30 to 150 (higher scores reflect higher levels of coping and problem-solving ability). Mean scores calculated on scales administered before the intervention will be compared to mean scores on scales administered after completion of the intervention.

  Up to 3 months after the first intervention

• Determine variability in scores on a validated scale assessing coping between those who receive PRISM and those who receive CFN.

  The Family Crisis Oriented Personal Scale (F-COPES) is a validated measure to assess coping. Possible scores range from 30 to 150 (higher scores reflect higher levels of coping and problem-solving ability). Variability in scores of scales collected before starting and after completion of the interventions will be calculated.

  Up to 3 months after the first intervention

• Determine mean scores on validated scale assessing quality of life in those who receive PRISM and those who receive CFN.

  The 36-Item Short Form Survey Instrument (SF-36) is a validated measure to assess quality of life. Possible scores range from 0-100 (higher scores reflect a more favorable health state). Mean scores calculated on scales administered before the intervention will be compared to mean scores on scales administered after completion of the intervention.

  Up to 3 months after the first intervention

• Determine change in mean in scores on validated scale assessing quality of life between those who receive PRISM and those who receive CFN.

  The 36-Item Short Form Survey Instrument (SF-36) is a validated measure to assess quality of life. Possible scores range from 0-100 (higher scores reflect a more favorable health state). Mean scores will be calculated on scales administered to subjects before the intervention and scales administered after intervention completion.

  Up to 3 months after the first intervention

• Determine variability in scores on a validated scale assessing quality of life between those who receive PRISM and those who receive CFN.

  The 36-Item Short Form Survey Instrument (SF-36) is a validated measure to assess quality of life. Possible scores range from 0-100 (higher scores reflect a more favorable health state). Variability in scores of scales collected before starting and after completion of the interventions will be calculated.

  Up to 3 months after the first intervention

Secondary Outcomes (1)

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

  Three months after completing the intervention, discussion groups will occur.

Study Arms (2)

Promoting Resilience in Stress Management (PRISM)

ACTIVE COMPARATOR

Behavioral: Promoting Resilience in Stress Management (PRISM)

Clinical-focused narrative (CFN)

ACTIVE COMPARATOR

Behavioral: Clinical-focused narrative (CFN)

Interventions

Promoting Resilience in Stress Management (PRISM) BEHAVIORAL

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.

Promoting Resilience in Stress Management (PRISM)

Clinical-focused narrative (CFN) BEHAVIORAL

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.

Clinical-focused narrative (CFN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females at least 18 years old
• Capable of giving consent, or there is a legally authorized representative capable of giving consent on the subject behalf and if appropriate, assent.
• Able to speak and read English
• Able to participate in Web- and App-based interventions
• Confirmed molecular diagnosis of primary mitochondrial disease

You may not qualify if:

• \. Suspected but no molecular diagnosis primary mitochondrial disease

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• North American Mitochondrial Disease Consortium (NAMDC): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Mitochondrial Diseases; Mitochondrial Myopathies; Mitochondrial Encephalomyopathies; MELAS Syndrome; MERRF Syndrome

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Brain Diseases, Metabolic, Inborn; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myoclonic Epilepsies, Progressive; Epilepsies, Myoclonic; Epilepsy, Generalized; Epilepsy; Epileptic Syndromes

Study Officials

• Elizabeth M McCormick, MS

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 25, 2023
• Study Start: September 22, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: By the time of publication
• Access Criteria: Anonymized participant data will be released to an NIH repository and will be available upon request.

Locations

US (1)