Agile Development of a Digital Exposure Treatment for Youth With Chronic Musculoskeletal Pain

NCT05079984 | Active Not Recruiting DMC

• 2 other identifiers: 533231K23AR079608-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Exposure; Adolescent Behavior; Child Behavior

Outcome Measures

Primary Outcomes (6)

• Assessment of Acceptability of Treatment Content and Digital Delivery Questionnaire - Likert Scale (Aim 1 and Aim 2)

  Participant-rated acceptability measured on 5-point Likert scale. Range 0-4 (higher scores indicate more acceptable). Questionnaire will be administered to youth with chronic pain and their parents.

  Baseline through 3-month follow-up (up to 22 weeks)

• Assessment of Acceptability of Treatment Content and Digital Delivery Questionnaire - Participant Responses (Aim 1 and Aim 2)

  Acceptability will be assessed qualitatively through participant responses to open-ended questions related to acceptability, ease of use, comprehensibility, and suggestions for improvement. Responses will be assessed categorically by the investigator. Questionnaire will be administered to youth with chronic pain and their parents.

  Baseline through 3-month follow-up (up to 22 weeks)

• Participant Satisfaction with the Intervention (Aim 1 and Aim 2)

  Treatment satisfaction at the end of treatment will be evaluated by examining mean satisfaction scores on an adapted version of the Pain Service Satisfaction Test (PSST, McCracken et al., 1997). The PSST consists of 23 items rated on a 5-point Likert Scale (0 = not at all satisfied to 4 = very satisfied) and assesses the patient and parent's experience of the intervention. Scores range from 0-92. A score greater than/equal to 40 of 60 (satisfied to very satisfied) will indicate high levels of satisfaction with the intervention content.

  19 weeks (Assessed at the end of treatment)

• Percentage of Participants Dropped Out of Intervention (Aim 2)

  As a measure of treatment adherence, we will calculate the percentage of participants who drop out or withdraw from the intervention prior to completion of the intervention.

  19 weeks (Assessed at the end of treatment)

• Expectations for Treatment (Aim 2)

  Participants (child) and parent expectations for treatment will be measured by the Treatment Expectancy and Creditability, Borkovec \& Nau, 1972). The TEC is comprised of 6 items rated on a 0 to 10 Likert-scale assessing expectations related to the effectiveness of the current treatment. The TEC is completed by the patient at the end of the first treatment session. Higher scores indicate greater expectations for treatment effectiveness.

  Baseline (up to 2 minutes to complete the survey)

• Functional Disability (Aim 2)

  Functional disability will be assessed using the Functional Disability Inventory (FDI, Walker \& Greene, 1991), a 15-item self-report measure of perceived difficulty in performing activities in school, home, physical, and social contexts. Items are rated on a 5-point Likert scale ranging from 0 (no trouble) to 4 (impossible). Items are summed to create a total score (range 0-60), with higher scores indicating greater disability.

  Baseline through 3-month follow-up (up to 22 weeks)

Secondary Outcomes (7)

• Child Fear of Pain (Aim 2)

  Baseline through 3-month follow-up (up to 22 weeks)

• Parental Fear of Pain (Aim 2)

  Baseline through 3-month follow-up (up to 22 weeks)

• Child Pain Catastrophizing (Aim 2)

  Baseline through 3-month follow-up (up to 22 weeks)

• Parent Pain Catastrophizing (Aim 2)

  Baseline through 3-month follow-up (up to 22 weeks)

• Child Pain Acceptance (Aim 2)

  Baseline through 3-month follow-up (up to 22 weeks)

Study Arms (1)

Graded Exposure Intervention

EXPERIMENTAL

For Aim 2, adolescents with chronic pain will be enrolled in a single-arm feasibility trial examining acceptability, feasibility, and preliminary effectiveness of a novel, digitally delivered, graded exposure treatment.

Behavioral: Graded exposure treatment (GET)

Interventions

Graded exposure treatment (GET) BEHAVIORAL

Graded-exposure is a theory driven, individually tailored, and evidenced based behavioral intervention for individuals with chronic pain targeting pain-related impairment by exposing patients to previously feared and avoided activities.

Graded Exposure Intervention

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Karolinska Institutet: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Pediatric Pain Management Clinic

Menlo Park, California, 94025, United States

Location

Related Publications (25)

• Huguet A, Miro J. The severity of chronic pediatric pain: an epidemiological study. J Pain. 2008 Mar;9(3):226-36. doi: 10.1016/j.jpain.2007.10.015. Epub 2007 Dec 21.

  PMID: 18088558 BACKGROUND

• King S, Chambers CT, Huguet A, MacNevin RC, McGrath PJ, Parker L, MacDonald AJ. The epidemiology of chronic pain in children and adolescents revisited: a systematic review. Pain. 2011 Dec;152(12):2729-2738. doi: 10.1016/j.pain.2011.07.016.

  PMID: 22078064 BACKGROUND

• Wilson K, Bell C, Wilson L, Witteman H. Agile research to complement agile development: a proposal for an mHealth research lifecycle. NPJ Digit Med. 2018 Sep 13;1:46. doi: 10.1038/s41746-018-0053-1. eCollection 2018.

  PMID: 31304326 BACKGROUND

• Groenewald CB, Essner BS, Wright D, Fesinmeyer MD, Palermo TM. The economic costs of chronic pain among a cohort of treatment-seeking adolescents in the United States. J Pain. 2014 Sep;15(9):925-33. doi: 10.1016/j.jpain.2014.06.002. Epub 2014 Jun 19.

  PMID: 24953887 BACKGROUND

• Murray CB, Groenewald CB, de la Vega R, Palermo TM. Long-term impact of adolescent chronic pain on young adult educational, vocational, and social outcomes. Pain. 2020 Feb;161(2):439-445. doi: 10.1097/j.pain.0000000000001732.

  PMID: 31651579 BACKGROUND

• Groenewald CB, Patel KV, Rabbitts JA, Palermo TM. Correlates and motivations of prescription opioid use among adolescents 12 to 17 years of age in the United States. Pain. 2020 Apr;161(4):742-748. doi: 10.1097/j.pain.0000000000001775.

  PMID: 31815917 BACKGROUND

• Peng P, Stinson JN, Choiniere M, Dion D, Intrater H, Lefort S, Lynch M, Ong M, Rashiq S, Tkachuk G, Veillette Y; STOPPAIN Investigators Group. Dedicated multidisciplinary pain management centres for children in Canada: the current status. Can J Anaesth. 2007 Dec;54(12):985-91. doi: 10.1007/BF03016632.

  PMID: 18056207 BACKGROUND

• Eccleston C, Blyth FM, Dear BF, Fisher EA, Keefe FJ, Lynch ME, Palermo TM, Reid MC, Williams ACC. Managing patients with chronic pain during the COVID-19 outbreak: considerations for the rapid introduction of remotely supported (eHealth) pain management services. Pain. 2020 May;161(5):889-893. doi: 10.1097/j.pain.0000000000001885. No abstract available.

  PMID: 32251203 BACKGROUND

• Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0.

  PMID: 10781906 BACKGROUND

• Vlaeyen JWS, Crombez G, Linton SJ. The fear-avoidance model of pain. Pain. 2016 Aug;157(8):1588-1589. doi: 10.1097/j.pain.0000000000000574. No abstract available.

  PMID: 27428892 BACKGROUND

• Vlaeyen JW, de Jong J, Geilen M, Heuts PH, van Breukelen G. The treatment of fear of movement/(re)injury in chronic low back pain: further evidence on the effectiveness of exposure in vivo. Clin J Pain. 2002 Jul-Aug;18(4):251-61. doi: 10.1097/00002508-200207000-00006.

  PMID: 12131067 BACKGROUND

• Simons LE, Harrison LE, O'Brien SF, Heirich MS, Loecher N, Boothroyd DB, Vlaeyen JWS, Wicksell RK, Schofield D, Hood KK, Orendurff M, Chan S, Lyons S. Graded exposure treatment for adolescents with chronic pain (GET Living): Protocol for a randomized controlled trial enhanced with single case experimental design. Contemp Clin Trials Commun. 2019 Sep 10;16:100448. doi: 10.1016/j.conctc.2019.100448. eCollection 2019 Dec.

  PMID: 31650069 BACKGROUND

• Simons LE, Sieberg CB, Carpino E, Logan D, Berde C. The Fear of Pain Questionnaire (FOPQ): assessment of pain-related fear among children and adolescents with chronic pain. J Pain. 2011 Jun;12(6):677-86. doi: 10.1016/j.jpain.2010.12.008. Epub 2011 Feb 26.

  PMID: 21354866 BACKGROUND

• Walker LS, Greene JW. The functional disability inventory: measuring a neglected dimension of child health status. J Pediatr Psychol. 1991 Feb;16(1):39-58. doi: 10.1093/jpepsy/16.1.39.

  PMID: 1826329 BACKGROUND

• Simons LE, Smith A, Kaczynski K, Basch M. Living in fear of your child's pain: the Parent Fear of Pain Questionnaire. Pain. 2015 Apr;156(4):694-702. doi: 10.1097/j.pain.0000000000000100.

  PMID: 25630026 BACKGROUND

• Goubert L, Eccleston C, Vervoort T, Jordan A, Crombez G. Parental catastrophizing about their child's pain. The parent version of the Pain Catastrophizing Scale (PCS-P): a preliminary validation. Pain. 2006 Aug;123(3):254-263. doi: 10.1016/j.pain.2006.02.035. Epub 2006 Apr 27.

  PMID: 16644128 BACKGROUND

• Claar RL, Guite JW, Kaczynski KJ, Logan DE. Factor structure of the Adult Responses to Children's Symptoms: validation in children and adolescents with diverse chronic pain conditions. Clin J Pain. 2010 Jun;26(5):410-7. doi: 10.1097/AJP.0b013e3181cf5706.

  PMID: 20473048 BACKGROUND

• Crombez G, Bijttebier P, Eccleston C, Mascagni T, Mertens G, Goubert L, Verstraeten K. The child version of the pain catastrophizing scale (PCS-C): a preliminary validation. Pain. 2003 Aug;104(3):639-646. doi: 10.1016/S0304-3959(03)00121-0.

  PMID: 12927636 BACKGROUND

• Timmers I, Simons LE, Hernandez JM, McCracken LM, Wallace DP. Parent psychological flexibility in the context of pediatric pain: Brief assessment and associations with parent behaviour and child functioning. Eur J Pain. 2019 Aug;23(7):1340-1350. doi: 10.1002/ejp.1403. Epub 2019 May 14.

  PMID: 31002473 BACKGROUND

• Gauntlett-Gilbert J, Alamire B, Duggan GB. Pain Acceptance in Adolescents: Development of a Short Form of the CPAQ-A. J Pediatr Psychol. 2019 May 1;44(4):453-462. doi: 10.1093/jpepsy/jsy090.

  PMID: 30496433 BACKGROUND

• Palermo T. Remote management of pediatric pain. Encyclopedia of Pain 2nd Edition New York: Springer 2013:3389-93

  BACKGROUND

• Borkovec TD, & Nau, S. D. . Credibility of analogue therapy rationales. Journal of Behavior Therapy and Experimental Psychology 1972;3:257-60

  BACKGROUND

• Simons LE, Vlaeyen JWS, Declercq L, Smith AM, Beebe J, Hogan M, Li E, Kronman CA, Mahmud F, Corey JR, Sieberg CB, Ploski C. Avoid or engage? Outcomes of graded exposure in youth with chronic pain using a sequential replicated single-case randomized design. Pain. 2020 Mar;161(3):520-531. doi: 10.1097/j.pain.0000000000001735.

  PMID: 31693541 BACKGROUND

• McCracken LM, Klock PA, Mingay DJ, Asbury JK, Sinclair DM. Assessment of satisfaction with treatment for chronic pain. J Pain Symptom Manage. 1997 Nov;14(5):292-9. doi: 10.1016/s0885-3924(97)00225-x.

  PMID: 9392923 BACKGROUND

• Harrison LE, Webster SN, Van Orden AR, Choate E, Jehl N, Stinson J, Wicksell RK, Bonnert M, Lalouni M, Darnall BD, Simons LE. Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy. BMJ Open. 2022 Sep 15;12(9):e065997. doi: 10.1136/bmjopen-2022-065997.

  PMID: 36109029 DERIVED

MeSH Terms

Conditions

Chronic Pain; Adolescent Behavior; Child Behavior

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Lauren E Harrison, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 15, 2021
• Study Start: May 2, 2022
• Primary Completion: May 13, 2025
• Study Completion: October 1, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)