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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through the completion of the study, on average 4 months.
Awards & highlights
Study Summary
This study is evaluating whether a new program may help improve pain and other symptoms for individuals with chronic pain.
Eligible Conditions
- Neurofibromatosis
- Chronic Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through the completion of the study, on average 4 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through the completion of the study, on average 4 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Engagement Activity
Pain Interference Index
Pain Severity
Secondary outcome measures
Anxiety
Chronic pain acceptance
Short Form/Quality of Life
+3 moreOther outcome measures
Mindfulness
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: iCanCopeExperimental Treatment1 Intervention
In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.
Group II: iCanCop+Contingency ManagementExperimental Treatment1 Intervention
In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
Group III: Control GroupActive Control1 Intervention
The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iCanCope
2021
N/A
~110
iCanCope+Contingency Management
2021
N/A
~110
Find a Location
Who is running the clinical trial?
Connecticut Children's Medical CenterOTHER
71 Previous Clinical Trials
31,406 Total Patients Enrolled
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,333 Total Patients Enrolled
United States Department of DefenseFED
865 Previous Clinical Trials
327,591 Total Patients Enrolled
1 Trials studying Neurofibromatosis
19 Patients Enrolled for Neurofibromatosis
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