Promoting Resilience in Stress Management (PRISM) and Clinical-focused Narrative (CFN) Pilot in Adults With Primary Mitochondrial Disease (PMD).
Primary Purpose
Mitochondrial Diseases, Mitochondrial Myopathies, Mitochondrial Encephalomyopathies
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Promoting Resilience in Stress Management (PRISM)
Clinical-focused narrative (CFN)
Sponsored by
About this trial
This is an interventional treatment trial for Mitochondrial Diseases
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 1. Suspected but no molecular diagnosis primary mitochondrial disease
Sites / Locations
- Children's Hospital of PhiladelphiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Promoting Resilience in Stress Management (PRISM)
Clinical-focused narrative (CFN)
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT06051448
First Posted
September 12, 2023
Last Updated
October 23, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
North American Mitochondrial Disease Consortium (NAMDC), National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT06051448
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
North American Mitochondrial Disease Consortium (NAMDC), National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitochondrial Diseases, Mitochondrial Myopathies, Mitochondrial Encephalomyopathies, MELAS, MERRF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Promoting Resilience in Stress Management (PRISM)
Arm Type
Active Comparator
Arm Title
Clinical-focused narrative (CFN)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Promoting Resilience in Stress Management (PRISM)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Clinical-focused narrative (CFN)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine mean score on validated scale assessing resilience in those who receive PRISM and those who receive CFN.
Description
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.
Time Frame
Up to 3 months after the first intervention
Title
Determine change in mean in scores on validated scale assessing resilience between those who receive PRISM and those who receive CFN.
Description
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.
Time Frame
Up to 3 months after the first intervention
Title
Determine variability in scores on validated scale assessing resilience between those who receive PRISM and those who receive CFN.
Description
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.
Time Frame
Up to 3 months after the first intervention
Title
Determine mean scores on validated scale assessing coping in those who receive PRISM and those who receive CFN.
Description
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.
Time Frame
Up to 3 months after the first intervention
Title
Determine change in mean scores on validated scale assessing coping between those who receive PRISM and those who receive CFN.
Description
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.
Time Frame
Up to 3 months after the first intervention
Title
Determine variability in scores on a validated scale assessing coping between those who receive PRISM and those who receive CFN.
Description
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.
Time Frame
Up to 3 months after the first intervention
Title
Determine mean scores on validated scale assessing quality of life in those who receive PRISM and those who receive CFN.
Description
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.
Time Frame
Up to 3 months after the first intervention
Title
Determine change in mean in scores on validated scale assessing quality of life between those who receive PRISM and those who receive CFN.
Description
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.
Time Frame
Up to 3 months after the first intervention
Title
Determine variability in scores on a validated scale assessing quality of life between those who receive PRISM and those who receive CFN.
Description
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.
Time Frame
Up to 3 months after the first intervention
Secondary Outcome Measure Information:
Title
Explore participant experience with PRISM and CFN and assess their acceptability among adults with primary mitochondrial disease.
Description
Semi-structured interviews will be conducted at discussion groups.
Time Frame
Three months after completing the intervention, discussion groups will occur.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
1. Suspected but no molecular diagnosis primary mitochondrial disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth M McCormick, MS
Phone
267-426-4961
Email
mccormicke@chop.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elana Qunell
Phone
267-426-4961
Email
qunelle@chop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth M McCormick, MS
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth M McCormick, MS
Phone
267-426-4961
Email
mccormicke@chop.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this study, without direct patient identifiers will be released to an NIH data repository for the purpose of facilitating data sharing according to NIH policy
IPD Sharing Time Frame
By the time of publication
IPD Sharing Access Criteria
Anonymized participant data will be released to an NIH repository and will be available upon request.
Learn more about this trial
Promoting Resilience in Stress Management (PRISM) and Clinical-focused Narrative (CFN) Pilot in Adults With Primary Mitochondrial Disease (PMD).
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