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

Innovation in the Treatment of Persistent Pain in Adults With Neurofibromatosis Type 1 (NF1): Implementation of the iCanCope Mobile Application- Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04561765
Enrollment
122
Registered
2020-09-24
Start date
2021-03-01
Completion date
2022-09-06
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Neurofibromatosis 1

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

DEVICEiCanCope

The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases

DEVICEiCanCope+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.

Sponsors

United States Department of Defense
CollaboratorFED
The Hospital for Sick Children
CollaboratorOTHER
Connecticut Children's Medical Center
CollaboratorOTHER
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

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

Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Pain Interference Indexthrough 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 Activitythrough 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 Severitythrough 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

MeasureTime frameDescription
Sleep Functioningthrough 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 Lifethrough 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: Avoidancethrough 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: Cognitivethrough 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 Acceptancethrough 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 Reviewthrough 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.
Anxietythrough 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

MeasureTime frameDescription
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

ArmCount
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
Total122

Baseline characteristics

CharacteristiciCanCopeTotalControl GroupiCanCop+Contingency Management
Age at Diagnosis11.7 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, Continuous42.4 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 Participants4 Participants2 Participants1 Participants
Children
Missing
19 Participants54 Participants15 Participants20 Participants
Children
No
9 Participants30 Participants10 Participants11 Participants
Children
Yes
11 Participants34 Participants13 Participants10 Participants
Degree
Advanced
4 Participants13 Participants5 Participants4 Participants
Degree
Associates
9 Participants20 Participants3 Participants8 Participants
Degree
Bachelors
10 Participants32 Participants9 Participants13 Participants
Degree
High School or GED
10 Participants28 Participants11 Participants7 Participants
Degree
Missing
0 Participants2 Participants1 Participants1 Participants
Degree
Some college
6 Participants21 Participants8 Participants7 Participants
Degree
Technical schooling
1 Participants6 Participants3 Participants2 Participants
Marital Status
Divorced
3 Participants9 Participants3 Participants3 Participants
Marital Status
Married
13 Participants48 Participants20 Participants15 Participants
Marital Status
MIssing
1 Participants1 Participants0 Participants0 Participants
Marital Status
Other
0 Participants1 Participants0 Participants1 Participants
Marital Status
Seperated
2 Participants2 Participants0 Participants0 Participants
Marital Status
Single
20 Participants59 Participants17 Participants22 Participants
Marital Status
Widowed
1 Participants2 Participants0 Participants1 Participants
Parents
Maybe
7 Participants12 Participants1 Participants4 Participants
Parents
No
20 Participants61 Participants17 Participants24 Participants
Parents
Yes
13 Participants49 Participants22 Participants14 Participants
Race/Ethnicity, Customized
American Indian or Alaskan
0 Participants1 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Asian
1 Participants3 Participants0 Participants2 Participants
Race/Ethnicity, Customized
Black or African American
2 Participants10 Participants4 Participants4 Participants
Race/Ethnicity, Customized
Other
3 Participants9 Participants3 Participants3 Participants
Race/Ethnicity, Customized
White
34 Participants99 Participants32 Participants33 Participants
Region of Enrollment
United States
40 participants122 participants40 participants42 participants
Sex/Gender, Customized
Female
27 Participants85 Participants28 Participants30 Participants
Sex/Gender, Customized
Male
12 Participants36 Participants12 Participants12 Participants
Sex/Gender, Customized
Other
1 Participants1 Participants0 Participants0 Participants
Surgeries
0
7 Participants18 Participants6 Participants5 Participants
Surgeries
11 or more
10 Participants23 Participants5 Participants8 Participants
Surgeries
1 to 3
14 Participants43 Participants12 Participants17 Participants
Surgeries
4 to 6
5 Participants14 Participants6 Participants3 Participants
Surgeries
7 to 10
2 Participants10 Participants5 Participants3 Participants
Surgeries
Unknown or missing
2 Participants14 Participants6 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 400 / 420 / 40
other
Total, other adverse events
0 / 400 / 420 / 40
serious
Total, serious adverse events
0 / 400 / 420 / 40

Outcome results

Primary

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.

ArmMeasureValue (MEAN)Dispersion
iCanCopeEngagement Activity4.7 minutes per dayStandard Deviation 3.9
iCanCope+Contingency ManagementEngagement Activity8.1 minutes per dayStandard Deviation 6.5
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
iCanCopePain Interference IndexDischarge (an average of 2 weeks)57.033 T-scoreStandard Deviation 7.45
iCanCopePain Interference IndexIntake (Baseline)57.709 T-scoreStandard Deviation 8.68
iCanCopePain Interference IndexFollow-Up (on average 4 months)57.783 T-scoreStandard Deviation 8.04
iCanCope+Contingency ManagementPain Interference IndexDischarge (an average of 2 weeks)54.965 T-scoreStandard Deviation 7.78
iCanCope+Contingency ManagementPain Interference IndexIntake (Baseline)58.666 T-scoreStandard Deviation 7.92
iCanCope+Contingency ManagementPain Interference IndexFollow-Up (on average 4 months)56.366 T-scoreStandard Deviation 9.47
Control GroupPain Interference IndexIntake (Baseline)59.394 T-scoreStandard Deviation 7.41
Control GroupPain Interference IndexFollow-Up (on average 4 months)59.424 T-scoreStandard Deviation 9.73
Control GroupPain Interference IndexDischarge (an average of 2 weeks)60.210 T-scoreStandard Deviation 9.21
Comparison: P value at discharge.p-value: 0.005ANOVA
Comparison: P value at discharge.p-value: 0.27ANOVA
Comparison: P value at discharge.p-value: 0.177ANOVA
Comparison: P Value at follow-up.p-value: 0.3ANOVA
p-value: 0.996ANOVA
p-value: 0.334ANOVA
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
iCanCopePain SeverityDischarge (about 2 weeks)4.164 score on a scaleStandard Deviation 1.99
iCanCopePain SeverityFollow-Up (on average 4 months)4.439 score on a scaleStandard Deviation 2.01
iCanCopePain SeverityIntake (Baseline)4.743 score on a scaleStandard Deviation 1.83
iCanCope+Contingency ManagementPain SeverityDischarge (about 2 weeks)3.778 score on a scaleStandard Deviation 2.48
iCanCope+Contingency ManagementPain SeverityIntake (Baseline)4.625 score on a scaleStandard Deviation 2.17
iCanCope+Contingency ManagementPain SeverityFollow-Up (on average 4 months)4.160 score on a scaleStandard Deviation 2.44
Control GroupPain SeverityDischarge (about 2 weeks)4.875 score on a scaleStandard Deviation 2.65
Control GroupPain SeverityIntake (Baseline)4.787 score on a scaleStandard Deviation 2.15
Control GroupPain SeverityFollow-Up (on average 4 months)4.375 score on a scaleStandard Deviation 2.47
Comparison: P values at follow-up.p-value: 0.991ANOVA
Comparison: P values at discharge.p-value: 0.963ANOVA
Comparison: P values at dischargep-value: 0.051ANOVA
Comparison: P values at discharge.p-value: 0.206ANOVA
Comparison: P values at dischargep-value: 0.765ANOVA
Comparison: P values at discharge.p-value: 0.916ANOVA
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
iCanCopeAnxietyDischarge (an average of 2 weeks)7.432 score on a scaleStandard Deviation 5.24
iCanCopeAnxietyFollow-Up (on average 4 months)6.889 score on a scaleStandard Deviation 4.77
iCanCopeAnxietyIntake (Baseline)7.865 score on a scaleStandard Deviation 5.21
iCanCope+Contingency ManagementAnxietyIntake (Baseline)7.457 score on a scaleStandard Deviation 4.56
iCanCope+Contingency ManagementAnxietyDischarge (an average of 2 weeks)5.667 score on a scaleStandard Deviation 3.65
iCanCope+Contingency ManagementAnxietyFollow-Up (on average 4 months)6.861 score on a scaleStandard Deviation 4.98
Control GroupAnxietyDischarge (an average of 2 weeks)8.871 score on a scaleStandard Deviation 6.48
Control GroupAnxietyIntake (Baseline)8.412 score on a scaleStandard Deviation 6.16
Control GroupAnxietyFollow-Up (on average 4 months)9.697 score on a scaleStandard Deviation 5.67
Comparison: P value at discharge.p-value: 0.212ANOVA
p-value: 0.965ANOVA
Comparison: P value at discharge.p-value: 0.294ANOVA
Comparison: P value at follow-up.p-value: 0.207ANOVA
Comparison: P value at follow-up.p-value: 0.158ANOVA
Comparison: P value at follow-up.p-value: 0.988ANOVA
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
iCanCopeChronic Pain AcceptanceFollow-Up (on average 4 months)66.774 score on a scaleStandard Deviation 9.51
iCanCopeChronic Pain AcceptanceDischarge (an average of 2 weeks)70.606 score on a scaleStandard Deviation 11.58
iCanCopeChronic Pain AcceptanceIntake (Baseline)65.517 score on a scaleStandard Deviation 12.64
iCanCope+Contingency ManagementChronic Pain AcceptanceFollow-Up (on average 4 months)70.462 score on a scaleStandard Deviation 8.98
iCanCope+Contingency ManagementChronic Pain AcceptanceIntake (Baseline)71.968 score on a scaleStandard Deviation 11.26
iCanCope+Contingency ManagementChronic Pain AcceptanceDischarge (an average of 2 weeks)72.333 score on a scaleStandard Deviation 8.26
Control GroupChronic Pain AcceptanceFollow-Up (on average 4 months)64.400 score on a scaleStandard Deviation 13.3
Control GroupChronic Pain AcceptanceIntake (Baseline)70.148 score on a scaleStandard Deviation 13.01
Control GroupChronic Pain AcceptanceDischarge (an average of 2 weeks)67.643 score on a scaleStandard Deviation 12.19
Comparison: P value at discharge.p-value: 0.333ANOVA
Comparison: P value at discharge.p-value: 0.003ANOVA
Comparison: P value at discharge.p-value: 0.106ANOVA
Comparison: P value at follow-up.p-value: 0.541ANOVA
Comparison: P value at follow-up.p-value: 0.202ANOVA
Comparison: P value at follow-up.p-value: 0.791ANOVA
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
iCanCopePsychological Inflexibility in Pain Scale: AvoidanceDischarge (an average of 2 weeks)22.676 score on a scaleStandard Deviation 13.26
iCanCopePsychological Inflexibility in Pain Scale: AvoidanceIntake (Baseline)26.361 score on a scaleStandard Deviation 15.87
iCanCopePsychological Inflexibility in Pain Scale: AvoidanceFollow-Up (on average 4 months)22.750 score on a scaleStandard Deviation 13.56
iCanCope+Contingency ManagementPsychological Inflexibility in Pain Scale: AvoidanceDischarge (an average of 2 weeks)22.639 score on a scaleStandard Deviation 11.81
iCanCope+Contingency ManagementPsychological Inflexibility in Pain Scale: AvoidanceIntake (Baseline)26.743 score on a scaleStandard Deviation 13.28
iCanCope+Contingency ManagementPsychological Inflexibility in Pain Scale: AvoidanceFollow-Up (on average 4 months)22.735 score on a scaleStandard Deviation 13.13
Control GroupPsychological Inflexibility in Pain Scale: AvoidanceIntake (Baseline)25.061 score on a scaleStandard Deviation 15.21
Control GroupPsychological Inflexibility in Pain Scale: AvoidanceFollow-Up (on average 4 months)27.290 score on a scaleStandard Deviation 14.58
Control GroupPsychological Inflexibility in Pain Scale: AvoidanceDischarge (an average of 2 weeks)27.194 score on a scaleStandard Deviation 16.7
Comparison: P value at discharge.p-value: 0.026ANOVA
Comparison: P value at discharge.p-value: 0.15ANOVA
p-value: 0.745ANOVA
Comparison: P value at follow-up.p-value: 0.021ANOVA
Comparison: P value at follow-up.p-value: 0.155ANOVA
Comparison: P value at follow-up.p-value: 0.652ANOVA
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
iCanCopePsychological Inflexibility in Pain Scale: CognitiveDischarge (an average of 2 weeks)21.833 score on a scaleStandard Deviation 5.53
iCanCopePsychological Inflexibility in Pain Scale: CognitiveIntake (Baseline)23.000 score on a scaleStandard Deviation 6.75
iCanCopePsychological Inflexibility in Pain Scale: CognitiveFollow-Up (on average 4 months)20.108 score on a scaleStandard Deviation 6.72
iCanCope+Contingency ManagementPsychological Inflexibility in Pain Scale: CognitiveDischarge (an average of 2 weeks)22.528 score on a scaleStandard Deviation 6.58
iCanCope+Contingency ManagementPsychological Inflexibility in Pain Scale: CognitiveIntake (Baseline)25.000 score on a scaleStandard Deviation 6.38
iCanCope+Contingency ManagementPsychological Inflexibility in Pain Scale: CognitiveFollow-Up (on average 4 months)21.800 score on a scaleStandard Deviation 7.02
Control GroupPsychological Inflexibility in Pain Scale: CognitiveIntake (Baseline)24.324 score on a scaleStandard Deviation 7.48
Control GroupPsychological Inflexibility in Pain Scale: CognitiveFollow-Up (on average 4 months)22.938 score on a scaleStandard Deviation 7.5
Control GroupPsychological Inflexibility in Pain Scale: CognitiveDischarge (an average of 2 weeks)23.844 score on a scaleStandard Deviation 6.58
Comparison: P value at discharge.p-value: 0.343ANOVA
Comparison: P value at discharge.p-value: 0.995ANOVA
Comparison: P value at discharge.p-value: 0.371ANOVA
Comparison: P value at follow-up.p-value: 0.228ANOVA
Comparison: P value at follow-up.p-value: 0.282ANOVA
p-value: 0.986ANOVA
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
iCanCopeShort Form/Quality of LifeDischarge (an average of 2 weeks)9.189 score on a scaleStandard Deviation 5.24
iCanCopeShort Form/Quality of LifeIntake (Baseline)9.342 score on a scaleStandard Deviation 5.77
iCanCopeShort Form/Quality of LifeFollow-Up (on average 4 months)8.737 score on a scaleStandard Deviation 4.84
iCanCope+Contingency ManagementShort Form/Quality of LifeDischarge (an average of 2 weeks)8.500 score on a scaleStandard Deviation 4.97
iCanCope+Contingency ManagementShort Form/Quality of LifeIntake (Baseline)9.167 score on a scaleStandard Deviation 5.02
iCanCope+Contingency ManagementShort Form/Quality of LifeFollow-Up (on average 4 months)9.556 score on a scaleStandard Deviation 6.39
Control GroupShort Form/Quality of LifeIntake (Baseline)10.500 score on a scaleStandard Deviation 6.11
Control GroupShort Form/Quality of LifeFollow-Up (on average 4 months)11.588 score on a scaleStandard Deviation 6.37
Control GroupShort Form/Quality of LifeDischarge (an average of 2 weeks)11.206 score on a scaleStandard Deviation 6.54
Comparison: P value at discharge.p-value: 0.295ANOVA
Comparison: P value at discharge.p-value: 0.718ANOVA
Comparison: P value at discharge.p-value: 0.738ANOVA
Comparison: P value at follow-up.p-value: 0.797ANOVA
Comparison: P value at follow-up.p-value: 0.26ANOVA
p-value: 0.616ANOVA
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
iCanCopeSleep Functioning22.4 score on a scaleStandard Deviation 6.4
iCanCope+Contingency ManagementSleep Functioning22.2 score on a scaleStandard Deviation 7.3
Control GroupSleep Functioning21.4 score on a scaleStandard Deviation 8.2
Secondary

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.

ArmMeasureGroupValue (NUMBER)
iCanCopeTreatment Services ReviewTrends presented to the user by the program27 themes
iCanCopeTreatment Services ReviewUser experience46 themes
iCanCopeTreatment Services ReviewCheck-ins29 themes
iCanCopeTreatment Services ReviewProfile set up5 themes
iCanCopeTreatment Services ReviewArticles presented to the user by program40 themes
iCanCopeTreatment Services ReviewGoals presented to the user by the program37 themes
iCanCopeTreatment Services ReviewImprovement suggestions40 themes
iCanCopeTreatment Services ReviewLiked most36 themes
iCanCopeTreatment Services ReviewLiked least25 themes
Other Pre-specified

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.

ArmMeasureValue (MEAN)Dispersion
iCanCopeMindfulness Based Alternative Approaches (MBAA)27.5 score on a scaleStandard Deviation 3.9
iCanCope+Contingency ManagementMindfulness Based Alternative Approaches (MBAA)28.2 score on a scaleStandard Deviation 2.4
Control GroupMindfulness Based Alternative Approaches (MBAA)28.9 score on a scaleStandard Deviation 2.5
p-value: 0.421ANOVA
p-value: 0.556ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026