Clinical trial NCT04561765: Innovation in the Treatment of Persistent Pain in Adults With NF1: Implementation of the iCanCope Mobile Application- Clinical Trial
Official title: Innovation in the Treatment of Persistent Pain in Adults With Neurofibromatosis Type 1 (NF1): Implementation of the iCanCope Mobile Application- Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurofibromatosis 1
Chronic Pain
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: The Hospital for Sick Children
name: Connecticut Children's Medical Center
First posted: 2020-09-24
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A 1x3 pilot randomized control trial (RCT) (iCanCope-NF, iCanCope-NF +Contingency Management (CM), Control Group) will be conducted with adults with NF1 who suffer from pain.
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Engagement Activity
timeFrame: through the completion of the study, on average 4 months.
measure: Pain Severity
timeFrame: through the completion of the study, on average 4 months.
measure: Pain Interference Index
timeFrame: through the completion of the study, on average 4 months.
Secondary outcomes:
measure: Treatment Services Review
timeFrame: through the completion of the study, on average 4 months.
measure: Anxiety
timeFrame: through the completion of the study, on average 4 months.
measure: Sleep Functioning
timeFrame: through the completion of the study, on average 4 months.
measure: Short Form/Quality of Life
timeFrame: through the completion of the study, on average 4 months.
measure: Chronic Pain Acceptance
timeFrame: through the completion of the study, on average 4 months.
measure: Psychological Inflexibility in Pain Scale: Avoidance
timeFrame: through the completion of the study, on average 4 months.
measure: Psychological Inflexibility in Pain Scale: Cognitive
timeFrame: through the completion of the study, on average 4 months.
Other outcomes:
measure: Mindfulness Based Alternative Approaches (MBAA)
timeFrame: through the completion of the study, on average 4 months.
Locations:
city: New Haven
country: United States
facility: Frank D Buono, PHD
state: Connecticut
Study officials:
References: