Clinical trial NCT05079984: Agile Development of a Digital Exposure Treatment for Youth With Chronic Musculoskeletal Pain
Official title: Agile Development of a Digital Exposure Treatment for Youth With Chronic Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Exposure
Adolescent Behavior
Child Behavior
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2021-10-15
Enrollment: 35
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project proposes to systematically develop and evaluate the feasibility and preliminary effectiveness of a digitally delivered, graded exposure treatment for youth with chronic musculoskeletal pain, utilizing a sequential replicated and randomized single-case experimental design (SCED). SCED provides the opportunity to rigorously evaluate treatment effectiveness at the individual level.

Development of iGET Living will be based on a series of short iterations, with alpha testing (Aim 1) on a small sample of adolescents with chronic pain (N = 15). For Aim 1, participants will participate in three, two hour focus groups (one per week over the course of three weeks), resulting in 6 total hours of participation per participant for Aim 1.

Aim 2 will involve a sample (N = 20 youth) of naïve end-users. Participants will be enrolled in a baseline period ranging from 7-25 days (done to support SCED methodology) after which they will be enrolled in the online intervention program, lasting 6-weeks. Patients will be contacted 3-months post-discharge from treatment (week 22 of enrollment) and will complete self-report outcome measures at this time.


Eligibility criteria: Inclusion Criteria:

* Youth ages 10-18
* Have diagnosis of chronic musculoskeletal pain (\>3months)
* Have moderate to high pain interference (PROMIS Pain Interference ≥ 61)
* English literate
* Have access to computer, smartphone, or tablet with internet connection

Exclusion Criteria:

* Significant cognitive impairment (e.g., brain injury)
* Significant medical or psychiatric problems that would interfere with treatment

Primary outcomes:
measure: Assessment of Acceptability of Treatment Content and Digital Delivery Questionnaire - Likert Scale (Aim 1 and Aim 2)
timeFrame: Baseline through 3-month follow-up (up to 22 weeks)
measure: Assessment of Acceptability of Treatment Content and Digital Delivery Questionnaire - Participant Responses (Aim 1 and Aim 2)
timeFrame: Baseline through 3-month follow-up (up to 22 weeks)
measure: Participant Satisfaction with the Intervention (Aim 1 and Aim 2)
timeFrame: 19 weeks (Assessed at the end of treatment)
measure: Percentage of Participants Dropped Out of Intervention (Aim 2)
timeFrame: 19 weeks (Assessed at the end of treatment)
measure: Expectations for Treatment (Aim 2)
timeFrame: Baseline (up to 2 minutes to complete the survey)
measure: Functional Disability (Aim 2)
timeFrame: Baseline through 3-month follow-up (up to 22 weeks)
Secondary outcomes:
measure: Child Fear of Pain (Aim 2)
timeFrame: Baseline through 3-month follow-up (up to 22 weeks)
measure: Parental Fear of Pain (Aim 2)
timeFrame: Baseline through 3-month follow-up (up to 22 weeks)
measure: Child Pain Catastrophizing (Aim 2)
timeFrame: Baseline through 3-month follow-up (up to 22 weeks)
measure: Parent Pain Catastrophizing (Aim 2)
timeFrame: Baseline through 3-month follow-up (up to 22 weeks)
measure: Child Pain Acceptance (Aim 2)
timeFrame: Baseline through 3-month follow-up (up to 22 weeks)
measure: Parent Psychological Flexibility (Aim 2)
timeFrame: Baseline through 3-month follow-up (up to 22 weeks)
measure: Parent Responses to Childs Pain (Aim 2)
timeFrame: Baseline through 3-month follow-up (up to 22 weeks)
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: Pediatric Pain Management Clinic
state: California
Study officials:
affiliation: Stanford University
name: Lauren E Harrison, PhD
role: PRINCIPAL_INVESTIGATOR
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