Innovation in the Treatment of Persistent Pain in Adults With Neurofibromatosis Type 1 (NF1): Implementation of the iCanCope Mobile Application- Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neurofibromatosis 1
- Sponsor
- Yale University
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Engagement Activity
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
To demonstrate the initial feasibility and determine preliminary impact on clinical outcomes of the iCanCope-NF program in a pilot RCT. If successful this pilot study will support conducting a larger randomized control trial (RCT). The primary research question is what is the feasibility of the iCanCope-NF program? The investigators define feasibility as (1) rates of accrual and dropout, daily log-ins, engagement, and outcome measures completed and (2) perceptions regarding intervention acceptability and satisfaction; and what are the levels of engagement. log-ins, with the intervention? The secondary questions are: (1) how does the iCanCope-NF program compare with the control condition in differences of pain and pain-related activity limitations, sleep functioning, emotional functioning (depression, anxiety), opioid usage, pain catastrophizing, self-efficacy, respondent burden (i.e. Physical Functioning, R, Vitality, Social Functioning, Role-Emotional, and Mental Health), and psychological flexibility immediately post-treatment (T2), (2) does the iCanCope-NF + CM increase the engagement of the iCanCope-NF program as compared to iCanCope-NF without CM, and do their corresponding levels of pain and pain-related activity decrease with CM?, and (3) do individuals with NF1 utilize the Mindfulness based alternative approaches (MBAA) to help reduce pain symptoms? The investigators hypothesize that by customizing and including MBAA to the program for adults with NF1, that individuals who engage regularly as seen through Analytics Platform for Evaluating Effective Engagement (APEEE) application, will acquire new sets of skills to facilitate pain management, while pain as reported with the Brief Pain Inventory will decrease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adults 18+
- •able to read and understand English at 5th grade level
- •permanently reside in the United States
- •have pain interference aggregate scores of three or more in the last two weeks using the Brief Pain Inventory-Short Form (BPI-SF) scale
Exclusion Criteria
- •have an undiagnosed case of NF1
- •have documented major co-occurring psychiatric disease
- •have moderate to severe cognitive deficits
- •have depression assessed using the Patient Health Questionnaire (PHQ-9) or anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7) greater than or equal to the appropriate thresholds (10=mild major depression; 5=mild severe anxiety)
Outcomes
Primary Outcomes
Engagement Activity
Time Frame: through the completion of the study, on average 4 months.
Average minutes per day logged on the mobile application will be evaluated between the two groups using the mobile application.
Pain Severity
Time Frame: through the completion of the study, on average 4 months.
A comparison within groups change of pain severity measured by the Brief Pain Inventory-Short Form. Respondents rate items on a 0-10 scale to indicate the pain severity and interference, and the total score is the mean of each subfactor. The higher the score indicates more severity and interference of pain.
Pain Interference Index
Time Frame: through the completion of the study, on average 4 months.
A comparison within groups change of pain interference measured by the Pain Interference Index Scale. Respondents rate items on a 0-6 scale to indicate how much pain has interfered with various activities, and the total score is the mean of the six items. Where 6 indicates high interference. Presented here are the non-linear converted T scores with a 'population' mean of 50 and standard deviation of 10. Scores above 50 indicate more pain interference.
Secondary Outcomes
- Treatment Services Review(through the completion of the study, on average 4 months.)
- Sleep Functioning(through the completion of the study, on average 4 months.)
- Short Form/Quality of Life(through the completion of the study, on average 4 months.)
- Chronic Pain Acceptance(through the completion of the study, on average 4 months.)
- Psychological Inflexibility in Pain Scale: Avoidance(through the completion of the study, on average 4 months.)
- Anxiety(through the completion of the study, on average 4 months.)
- Psychological Inflexibility in Pain Scale: Cognitive(through the completion of the study, on average 4 months.)