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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05079984
• Other study ID #: 53323
• Secondary ID: 1K23AR079608-01
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: May 1, 2026

Study information

• Verified date: June 2024
• Source: Stanford University
• Contact: Lauren E Harrison, PhD
• Phone: 650-498-2486
• Email: leharr[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: May 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Child Behavior
• Chronic Pain
• Exposure
• Musculoskeletal Pain

Intervention

Behavioral:
• Graded exposure treatment (GET)
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.

Locations

Country	Name	City	State
United States	Pediatric Pain Management Clinic	Menlo Park	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Karolinska Institutet, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (24)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Child Fear of Pain (Aim 2)	Fear of Pain Questionnaire- Child (FOPQ-C, Simons et al., 2011) consists of 24 items, with each item rated on a 5-point Likert scale (0 = "strongly disagree" to 4 = "strongly agree"). The FOPQ-C contains two subscales: Fear of Pain (11 items) and Avoidance of Activities (13 items). Total score is derived by summing subscale items, with higher scores indicating greater pain related fear (score range 0-44) and avoidance of activities (score range 0-52).	Baseline through 3-month follow-up (up to 22 weeks)
Secondary	Parental Fear of Pain (Aim 2)	The Parent Fear of Pain Questionnaire (PFOPQ, Simons et al., 2015) assesses parent's fear associated with their child's pain experiences. The PFOPQ contains 23 items assessed on a 5-point Likert scale (0 = "strongly disagree" to 4 "strongly agree"). Items are summed to create a total score (0-92), with higher scores indicated greater parent fear associated with their child's pain.	Baseline through 3-month follow-up (up to 22 weeks)
Secondary	Child Pain Catastrophizing (Aim 2)	The Pain Catastrophizing Scale -Child Version (PCS-C, Crombez et al., 2003) assesses negative cognitions associated with pain. The PCS-C is comprised of 13-items rated on a 5-point Likert scale (0= "not at all true" to 4 "very true"). A total score (0-52) is obtained by summing all items. Higher scores indicate higher levels of catastrophic thinking.	Baseline through 3-month follow-up (up to 22 weeks)
Secondary	Parent Pain Catastrophizing (Aim 2)	Pain Catastrophizing Scale-Parent Version (PCS-P, Goubert et al., 2006) assesses parents' negative cognitions associated with their child's pain. It is comprised of 13 items rated on a 5-point Likert scale (0 = "not true at all" to 4 = "very true"). A total score (0-52) is derived by summing items, with higher scores indicating higher levels of catastrophic thinking.	Baseline through 3-month follow-up (up to 22 weeks)
Secondary	Child Pain Acceptance (Aim 2)	Child report on the Chronic Pain Acceptance Questionnaire for Adolescents-short form (CPAQ-A8, Gauntlett-Gilbert et al., 2018) will be used to assess pain acceptance in the child. The CPAQ-A8 is an 8-item measure consisting of two subscales: Activity Engagement (4 items) and Pain Willingness (4 items). Items are rated on a 5-point Likert scale ranging from 0 (Never True) to 4 (Always True) and yield a total score for each subscale ranging from 0-16. Higher scores indicate greater Activity Engagement and greater Pain Willingness .	Baseline through 3-month follow-up (up to 22 weeks)
Secondary	Parent Psychological Flexibility (Aim 2)	The Parent Psychological Flexibility Questionnaire (PPFQ-10, Timmers et al., 2019) is a 10-item parent self-report questionnaire assessing a parent's ability to accept their own distress and respond adaptively and flexibly to their child's pain. Items are rated on a 5-point Likert scale (0= " never true" to 4 = "always true") and are summed to create a total score, ranging from 0 - 40. Higher scores indicate greater parent psychological flexibility.	Baseline through 3-month follow-up (up to 22 weeks)
Secondary	Parent Responses to Childs Pain (Aim 2)	Adult Responses to Children's Symptoms (ARCS, Claar et al., 2010) assesses parents' behavioral responses to children's pain behaviors. The Protect subscale (13 items) will be utilized in this study. The Protect scale refers to protective parental behavior, such as giving the child special attention and limiting the child's normal activities and responsibilities. All items are rated on a 5-point Likert scale (0 = "never" to 4 "always"), and are averaged to create a total score ranging from 0-4. Hiigher scores indicating greater use of a particular type of response to their child's pain.	Baseline through 3-month follow-up (up to 22 weeks)