Mitochondrial Diseases Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | National Institute of Neurological Disorders and Stroke (NINDS), North American Mitochondrial Disease Consortium (NAMDC) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Explore participant experience with PRISM and CFN and assess their acceptability among adults with primary mitochondrial disease. | Semi-structured interviews will be conducted at discussion groups. | Three months after completing the intervention, discussion groups will occur. |
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