Chronic Pain, Neurofibromatosis 1
Conditions
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.
Interventions
The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
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.
Sponsors
Study design
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.
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference Index | 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. |
| Engagement Activity | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Functioning | through the completion of the study, on average 4 months. | A comparison within change of sleep quality measured by the PROMIS Sleep inventory. The higher the total score, the more severe the symptom. Total scores less than 24 suggest no to slight sleep disturbance, 24-28 suggest mild disturbance, 29-38 moderate disturbance, and greater than 38 severe sleep disturbance. The score has a range of 0 to 40. |
| Short Form/Quality of Life | through the completion of the study, on average 4 months. | the Short form survey 20- will measure quality of life across 8 subscales on respondent burden (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health). Scores were transformed linearly to 0-100 scales, with 0 and 100 assigned to the lowest and highest possible scores, where high value indicated better functioning. |
| Psychological Inflexibility in Pain Scale: Avoidance | through the completion of the study, on average 4 months. | Psychological Inflexibility in Pain Scale (PIPS) Avoidance subscale is a 10-item scale used to assess psychological inflexibility in people with chronic pain will be measured across all groups. Respondents are asked to rate items on a 7-point scale that ranges from 1 (never true) to 7 (always true). The total score was calculated by summing the responses for each of the items. Higher scores indicate greater levels of psychological inflexibility. Total score range for the Avoidance subscale is 10-70. The PIPS outcome was originally registered as a single item. |
| Psychological Inflexibility in Pain Scale: Cognitive | through the completion of the study, on average 4 months. | Psychological Inflexibility in Pain Scale (PIPS) Cognitive subscale is a 6-item scale used to assess psychological inflexibility in people with chronic pain will be measured across all groups. Respondents are asked to rate items on a 7-point scale that ranges from 1 (never true) to 7 (always true). The total score was calculated by summing the responses for each of the items. Higher scores indicate greater levels of psychological inflexibility. Total score range for Cognitive subscale is 6-42. The PIPS outcome was originally registered as a single item. |
| Chronic Pain Acceptance | through the completion of the study, on average 4 months. | Chronic Pain Acceptance Questionnaire-Revised (CPAQ-Revised) 20-item scale designed to measure acceptance of pain. The acceptance of chronic pain is thought to reduce unsuccessful attempts to avoid or control pain and thus focus on engaging in valued activities and pursuing meaningful goals will be measured across all groups. The items on the CPAQ are rated on a 7-point scale from 0 (never true) to 6 (always true). To score the CPAQ, add the items for Activity engagement and Pain willingness to obtain a score for each factor. To obtain the total score, add the scores for each factor together. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance. |
| Treatment Services Review | through the completion of the study, on average 4 months. | What are perceptions of satisfaction across groups exposed to the iCanCope mobile application using an The Treatment Services Review (TSR). Data presented here represents the themes that emerged from the qualitative interviews. |
| Anxiety | through the completion of the study, on average 4 months. | A comparison within change of generalized anxiety measured by the generalized anxiety disorder scale (GAD-7). After reading each statement, one of four choices are provided and respondents can select one response (1=not at all sure, 2=several days, 3=over half days, 4=nearly every day). Each column is then added, and a total score is obtained, with scores falling into four levels of anxiety, including minimal (1-4), mild (5-9), moderate (10-14), and severe (15-21) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mindfulness Based Alternative Approaches (MBAA) | through the completion of the study, on average 4 months. | Do individuals with NF-1 utilize the MBAA more readily because they are on the mobile application, via Five Facet Mindfulness Questionnaire. 39-item self-completed questionnaire measuring the five facets of mindfulness: Observing (8 items), Describing (8 items), Acting with awareness (8 items), Non-judgmental (8 items), and Non-reactive (7 items). Total score ranges from 8 to 40. Higher scores indicating greater mindfulness. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| iCanCope 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.
iCanCope: The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases | 40 |
| iCanCop+Contingency Management 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.
iCanCope+Contingency Management: 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. | 42 |
| Control Group 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. | 40 |
| Total | 122 |
Baseline characteristics
| Characteristic | iCanCope | Total | Control Group | iCanCop+Contingency Management |
|---|---|---|---|---|
| Age at Diagnosis | 11.7 years STANDARD_DEVIATION 13.1 | 11.2 years STANDARD_DEVIATION 12.3 | 11.5 years STANDARD_DEVIATION 12.2 | 10.3 years STANDARD_DEVIATION 11.8 |
| Age, Continuous | 42.4 years STANDARD_DEVIATION 12.9 | 42.4 years STANDARD_DEVIATION 12.6 | 45.6 years STANDARD_DEVIATION 10.5 | 40.9 years STANDARD_DEVIATION 13.2 |
| Children Maybe | 1 Participants | 4 Participants | 2 Participants | 1 Participants |
| Children Missing | 19 Participants | 54 Participants | 15 Participants | 20 Participants |
| Children No | 9 Participants | 30 Participants | 10 Participants | 11 Participants |
| Children Yes | 11 Participants | 34 Participants | 13 Participants | 10 Participants |
| Degree Advanced | 4 Participants | 13 Participants | 5 Participants | 4 Participants |
| Degree Associates | 9 Participants | 20 Participants | 3 Participants | 8 Participants |
| Degree Bachelors | 10 Participants | 32 Participants | 9 Participants | 13 Participants |
| Degree High School or GED | 10 Participants | 28 Participants | 11 Participants | 7 Participants |
| Degree Missing | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Degree Some college | 6 Participants | 21 Participants | 8 Participants | 7 Participants |
| Degree Technical schooling | 1 Participants | 6 Participants | 3 Participants | 2 Participants |
| Marital Status Divorced | 3 Participants | 9 Participants | 3 Participants | 3 Participants |
| Marital Status Married | 13 Participants | 48 Participants | 20 Participants | 15 Participants |
| Marital Status MIssing | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Marital Status Other | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Marital Status Seperated | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Marital Status Single | 20 Participants | 59 Participants | 17 Participants | 22 Participants |
| Marital Status Widowed | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Parents Maybe | 7 Participants | 12 Participants | 1 Participants | 4 Participants |
| Parents No | 20 Participants | 61 Participants | 17 Participants | 24 Participants |
| Parents Yes | 13 Participants | 49 Participants | 22 Participants | 14 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 10 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 9 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 34 Participants | 99 Participants | 32 Participants | 33 Participants |
| Region of Enrollment United States | 40 participants | 122 participants | 40 participants | 42 participants |
| Sex/Gender, Customized Female | 27 Participants | 85 Participants | 28 Participants | 30 Participants |
| Sex/Gender, Customized Male | 12 Participants | 36 Participants | 12 Participants | 12 Participants |
| Sex/Gender, Customized Other | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Surgeries 0 | 7 Participants | 18 Participants | 6 Participants | 5 Participants |
| Surgeries 11 or more | 10 Participants | 23 Participants | 5 Participants | 8 Participants |
| Surgeries 1 to 3 | 14 Participants | 43 Participants | 12 Participants | 17 Participants |
| Surgeries 4 to 6 | 5 Participants | 14 Participants | 6 Participants | 3 Participants |
| Surgeries 7 to 10 | 2 Participants | 10 Participants | 5 Participants | 3 Participants |
| Surgeries Unknown or missing | 2 Participants | 14 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 42 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 42 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 42 | 0 / 40 |
Outcome results
Engagement Activity
Average minutes per day logged on the mobile application will be evaluated between the two groups using the mobile application.
Time frame: through the completion of the study, on average 4 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCanCope | Engagement Activity | 4.7 minutes per day | Standard Deviation 3.9 |
| iCanCope+Contingency Management | Engagement Activity | 8.1 minutes per day | Standard Deviation 6.5 |
Pain Interference Index
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.
Time frame: through the completion of the study, on average 4 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCanCope | Pain Interference Index | Discharge (an average of 2 weeks) | 57.033 T-score | Standard Deviation 7.45 |
| iCanCope | Pain Interference Index | Intake (Baseline) | 57.709 T-score | Standard Deviation 8.68 |
| iCanCope | Pain Interference Index | Follow-Up (on average 4 months) | 57.783 T-score | Standard Deviation 8.04 |
| iCanCope+Contingency Management | Pain Interference Index | Discharge (an average of 2 weeks) | 54.965 T-score | Standard Deviation 7.78 |
| iCanCope+Contingency Management | Pain Interference Index | Intake (Baseline) | 58.666 T-score | Standard Deviation 7.92 |
| iCanCope+Contingency Management | Pain Interference Index | Follow-Up (on average 4 months) | 56.366 T-score | Standard Deviation 9.47 |
| Control Group | Pain Interference Index | Intake (Baseline) | 59.394 T-score | Standard Deviation 7.41 |
| Control Group | Pain Interference Index | Follow-Up (on average 4 months) | 59.424 T-score | Standard Deviation 9.73 |
| Control Group | Pain Interference Index | Discharge (an average of 2 weeks) | 60.210 T-score | Standard Deviation 9.21 |
Pain Severity
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.
Time frame: through the completion of the study, on average 4 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCanCope | Pain Severity | Discharge (about 2 weeks) | 4.164 score on a scale | Standard Deviation 1.99 |
| iCanCope | Pain Severity | Follow-Up (on average 4 months) | 4.439 score on a scale | Standard Deviation 2.01 |
| iCanCope | Pain Severity | Intake (Baseline) | 4.743 score on a scale | Standard Deviation 1.83 |
| iCanCope+Contingency Management | Pain Severity | Discharge (about 2 weeks) | 3.778 score on a scale | Standard Deviation 2.48 |
| iCanCope+Contingency Management | Pain Severity | Intake (Baseline) | 4.625 score on a scale | Standard Deviation 2.17 |
| iCanCope+Contingency Management | Pain Severity | Follow-Up (on average 4 months) | 4.160 score on a scale | Standard Deviation 2.44 |
| Control Group | Pain Severity | Discharge (about 2 weeks) | 4.875 score on a scale | Standard Deviation 2.65 |
| Control Group | Pain Severity | Intake (Baseline) | 4.787 score on a scale | Standard Deviation 2.15 |
| Control Group | Pain Severity | Follow-Up (on average 4 months) | 4.375 score on a scale | Standard Deviation 2.47 |
Anxiety
A comparison within change of generalized anxiety measured by the generalized anxiety disorder scale (GAD-7). After reading each statement, one of four choices are provided and respondents can select one response (1=not at all sure, 2=several days, 3=over half days, 4=nearly every day). Each column is then added, and a total score is obtained, with scores falling into four levels of anxiety, including minimal (1-4), mild (5-9), moderate (10-14), and severe (15-21)
Time frame: through the completion of the study, on average 4 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCanCope | Anxiety | Discharge (an average of 2 weeks) | 7.432 score on a scale | Standard Deviation 5.24 |
| iCanCope | Anxiety | Follow-Up (on average 4 months) | 6.889 score on a scale | Standard Deviation 4.77 |
| iCanCope | Anxiety | Intake (Baseline) | 7.865 score on a scale | Standard Deviation 5.21 |
| iCanCope+Contingency Management | Anxiety | Intake (Baseline) | 7.457 score on a scale | Standard Deviation 4.56 |
| iCanCope+Contingency Management | Anxiety | Discharge (an average of 2 weeks) | 5.667 score on a scale | Standard Deviation 3.65 |
| iCanCope+Contingency Management | Anxiety | Follow-Up (on average 4 months) | 6.861 score on a scale | Standard Deviation 4.98 |
| Control Group | Anxiety | Discharge (an average of 2 weeks) | 8.871 score on a scale | Standard Deviation 6.48 |
| Control Group | Anxiety | Intake (Baseline) | 8.412 score on a scale | Standard Deviation 6.16 |
| Control Group | Anxiety | Follow-Up (on average 4 months) | 9.697 score on a scale | Standard Deviation 5.67 |
Chronic Pain Acceptance
Chronic Pain Acceptance Questionnaire-Revised (CPAQ-Revised) 20-item scale designed to measure acceptance of pain. The acceptance of chronic pain is thought to reduce unsuccessful attempts to avoid or control pain and thus focus on engaging in valued activities and pursuing meaningful goals will be measured across all groups. The items on the CPAQ are rated on a 7-point scale from 0 (never true) to 6 (always true). To score the CPAQ, add the items for Activity engagement and Pain willingness to obtain a score for each factor. To obtain the total score, add the scores for each factor together. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance.
Time frame: through the completion of the study, on average 4 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCanCope | Chronic Pain Acceptance | Follow-Up (on average 4 months) | 66.774 score on a scale | Standard Deviation 9.51 |
| iCanCope | Chronic Pain Acceptance | Discharge (an average of 2 weeks) | 70.606 score on a scale | Standard Deviation 11.58 |
| iCanCope | Chronic Pain Acceptance | Intake (Baseline) | 65.517 score on a scale | Standard Deviation 12.64 |
| iCanCope+Contingency Management | Chronic Pain Acceptance | Follow-Up (on average 4 months) | 70.462 score on a scale | Standard Deviation 8.98 |
| iCanCope+Contingency Management | Chronic Pain Acceptance | Intake (Baseline) | 71.968 score on a scale | Standard Deviation 11.26 |
| iCanCope+Contingency Management | Chronic Pain Acceptance | Discharge (an average of 2 weeks) | 72.333 score on a scale | Standard Deviation 8.26 |
| Control Group | Chronic Pain Acceptance | Follow-Up (on average 4 months) | 64.400 score on a scale | Standard Deviation 13.3 |
| Control Group | Chronic Pain Acceptance | Intake (Baseline) | 70.148 score on a scale | Standard Deviation 13.01 |
| Control Group | Chronic Pain Acceptance | Discharge (an average of 2 weeks) | 67.643 score on a scale | Standard Deviation 12.19 |
Psychological Inflexibility in Pain Scale: Avoidance
Psychological Inflexibility in Pain Scale (PIPS) Avoidance subscale is a 10-item scale used to assess psychological inflexibility in people with chronic pain will be measured across all groups. Respondents are asked to rate items on a 7-point scale that ranges from 1 (never true) to 7 (always true). The total score was calculated by summing the responses for each of the items. Higher scores indicate greater levels of psychological inflexibility. Total score range for the Avoidance subscale is 10-70. The PIPS outcome was originally registered as a single item.
Time frame: through the completion of the study, on average 4 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCanCope | Psychological Inflexibility in Pain Scale: Avoidance | Discharge (an average of 2 weeks) | 22.676 score on a scale | Standard Deviation 13.26 |
| iCanCope | Psychological Inflexibility in Pain Scale: Avoidance | Intake (Baseline) | 26.361 score on a scale | Standard Deviation 15.87 |
| iCanCope | Psychological Inflexibility in Pain Scale: Avoidance | Follow-Up (on average 4 months) | 22.750 score on a scale | Standard Deviation 13.56 |
| iCanCope+Contingency Management | Psychological Inflexibility in Pain Scale: Avoidance | Discharge (an average of 2 weeks) | 22.639 score on a scale | Standard Deviation 11.81 |
| iCanCope+Contingency Management | Psychological Inflexibility in Pain Scale: Avoidance | Intake (Baseline) | 26.743 score on a scale | Standard Deviation 13.28 |
| iCanCope+Contingency Management | Psychological Inflexibility in Pain Scale: Avoidance | Follow-Up (on average 4 months) | 22.735 score on a scale | Standard Deviation 13.13 |
| Control Group | Psychological Inflexibility in Pain Scale: Avoidance | Intake (Baseline) | 25.061 score on a scale | Standard Deviation 15.21 |
| Control Group | Psychological Inflexibility in Pain Scale: Avoidance | Follow-Up (on average 4 months) | 27.290 score on a scale | Standard Deviation 14.58 |
| Control Group | Psychological Inflexibility in Pain Scale: Avoidance | Discharge (an average of 2 weeks) | 27.194 score on a scale | Standard Deviation 16.7 |
Psychological Inflexibility in Pain Scale: Cognitive
Psychological Inflexibility in Pain Scale (PIPS) Cognitive subscale is a 6-item scale used to assess psychological inflexibility in people with chronic pain will be measured across all groups. Respondents are asked to rate items on a 7-point scale that ranges from 1 (never true) to 7 (always true). The total score was calculated by summing the responses for each of the items. Higher scores indicate greater levels of psychological inflexibility. Total score range for Cognitive subscale is 6-42. The PIPS outcome was originally registered as a single item.
Time frame: through the completion of the study, on average 4 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCanCope | Psychological Inflexibility in Pain Scale: Cognitive | Discharge (an average of 2 weeks) | 21.833 score on a scale | Standard Deviation 5.53 |
| iCanCope | Psychological Inflexibility in Pain Scale: Cognitive | Intake (Baseline) | 23.000 score on a scale | Standard Deviation 6.75 |
| iCanCope | Psychological Inflexibility in Pain Scale: Cognitive | Follow-Up (on average 4 months) | 20.108 score on a scale | Standard Deviation 6.72 |
| iCanCope+Contingency Management | Psychological Inflexibility in Pain Scale: Cognitive | Discharge (an average of 2 weeks) | 22.528 score on a scale | Standard Deviation 6.58 |
| iCanCope+Contingency Management | Psychological Inflexibility in Pain Scale: Cognitive | Intake (Baseline) | 25.000 score on a scale | Standard Deviation 6.38 |
| iCanCope+Contingency Management | Psychological Inflexibility in Pain Scale: Cognitive | Follow-Up (on average 4 months) | 21.800 score on a scale | Standard Deviation 7.02 |
| Control Group | Psychological Inflexibility in Pain Scale: Cognitive | Intake (Baseline) | 24.324 score on a scale | Standard Deviation 7.48 |
| Control Group | Psychological Inflexibility in Pain Scale: Cognitive | Follow-Up (on average 4 months) | 22.938 score on a scale | Standard Deviation 7.5 |
| Control Group | Psychological Inflexibility in Pain Scale: Cognitive | Discharge (an average of 2 weeks) | 23.844 score on a scale | Standard Deviation 6.58 |
Short Form/Quality of Life
the Short form survey 20- will measure quality of life across 8 subscales on respondent burden (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health). Scores were transformed linearly to 0-100 scales, with 0 and 100 assigned to the lowest and highest possible scores, where high value indicated better functioning.
Time frame: through the completion of the study, on average 4 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCanCope | Short Form/Quality of Life | Discharge (an average of 2 weeks) | 9.189 score on a scale | Standard Deviation 5.24 |
| iCanCope | Short Form/Quality of Life | Intake (Baseline) | 9.342 score on a scale | Standard Deviation 5.77 |
| iCanCope | Short Form/Quality of Life | Follow-Up (on average 4 months) | 8.737 score on a scale | Standard Deviation 4.84 |
| iCanCope+Contingency Management | Short Form/Quality of Life | Discharge (an average of 2 weeks) | 8.500 score on a scale | Standard Deviation 4.97 |
| iCanCope+Contingency Management | Short Form/Quality of Life | Intake (Baseline) | 9.167 score on a scale | Standard Deviation 5.02 |
| iCanCope+Contingency Management | Short Form/Quality of Life | Follow-Up (on average 4 months) | 9.556 score on a scale | Standard Deviation 6.39 |
| Control Group | Short Form/Quality of Life | Intake (Baseline) | 10.500 score on a scale | Standard Deviation 6.11 |
| Control Group | Short Form/Quality of Life | Follow-Up (on average 4 months) | 11.588 score on a scale | Standard Deviation 6.37 |
| Control Group | Short Form/Quality of Life | Discharge (an average of 2 weeks) | 11.206 score on a scale | Standard Deviation 6.54 |
Sleep Functioning
A comparison within change of sleep quality measured by the PROMIS Sleep inventory. The higher the total score, the more severe the symptom. Total scores less than 24 suggest no to slight sleep disturbance, 24-28 suggest mild disturbance, 29-38 moderate disturbance, and greater than 38 severe sleep disturbance. The score has a range of 0 to 40.
Time frame: through the completion of the study, on average 4 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCanCope | Sleep Functioning | 22.4 score on a scale | Standard Deviation 6.4 |
| iCanCope+Contingency Management | Sleep Functioning | 22.2 score on a scale | Standard Deviation 7.3 |
| Control Group | Sleep Functioning | 21.4 score on a scale | Standard Deviation 8.2 |
Treatment Services Review
What are perceptions of satisfaction across groups exposed to the iCanCope mobile application using an The Treatment Services Review (TSR). Data presented here represents the themes that emerged from the qualitative interviews.
Time frame: through the completion of the study, on average 4 months.
Population: This outcome was collected aggregately to evaluate feasibility of the mobile application and to assess for generalized acceptability of the mobile application. Due to this, the results were not looked at per arm but together to assess overall qualitative themes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| iCanCope | Treatment Services Review | Trends presented to the user by the program | 27 themes |
| iCanCope | Treatment Services Review | User experience | 46 themes |
| iCanCope | Treatment Services Review | Check-ins | 29 themes |
| iCanCope | Treatment Services Review | Profile set up | 5 themes |
| iCanCope | Treatment Services Review | Articles presented to the user by program | 40 themes |
| iCanCope | Treatment Services Review | Goals presented to the user by the program | 37 themes |
| iCanCope | Treatment Services Review | Improvement suggestions | 40 themes |
| iCanCope | Treatment Services Review | Liked most | 36 themes |
| iCanCope | Treatment Services Review | Liked least | 25 themes |
Mindfulness Based Alternative Approaches (MBAA)
Do individuals with NF-1 utilize the MBAA more readily because they are on the mobile application, via Five Facet Mindfulness Questionnaire. 39-item self-completed questionnaire measuring the five facets of mindfulness: Observing (8 items), Describing (8 items), Acting with awareness (8 items), Non-judgmental (8 items), and Non-reactive (7 items). Total score ranges from 8 to 40. Higher scores indicating greater mindfulness.
Time frame: through the completion of the study, on average 4 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCanCope | Mindfulness Based Alternative Approaches (MBAA) | 27.5 score on a scale | Standard Deviation 3.9 |
| iCanCope+Contingency Management | Mindfulness Based Alternative Approaches (MBAA) | 28.2 score on a scale | Standard Deviation 2.4 |
| Control Group | Mindfulness Based Alternative Approaches (MBAA) | 28.9 score on a scale | Standard Deviation 2.5 |