Innovation in the Treatment of Persistent Pain in Adults With NF1: Implementation of the iCanCope Mobile Application- Clinical Trial

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Brief Title

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 NF1: Implementation of the iCanCope Mobile Application- Clinical Trial

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 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.
    



Study Type

Interventional


Primary Outcome

Engagement Activity

Secondary Outcome

 Treatment Services Review

Condition

Neurofibromatosis 1

Intervention

iCanCope

Study Arms / Comparison Groups

 iCanCope
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

108

Start Date

March 1, 2021

Completion Date

August 1, 2022

Primary Completion Date

July 30, 2022

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)
      

Gender

All

Ages

18 Years - 72 Years

Accepts Healthy Volunteers

No

Contacts

, 8478496007, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04561765

Organization ID

2000029045


Responsible Party

Principal Investigator

Study Sponsor

Yale University

Collaborators

 United States Department of Defense

Study Sponsor

, , 


Verification Date

March 2021