GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain

NCT03699007 | Completed Results DMC

• 2 other identifiers: 395141R21AR072921-01A1
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The broad aim of this study is to implement and evaluate the efficacy of Graded Exposure Treatment (GET Living) to target elevated pain-related fears in children with chronic pain at the Stanford Pediatric Pain Management Clinic (PPMC). The investigators will evaluate the effectiveness and acceptability of this intervention for children with high levels of pain-related fear and functional disability. If proven efficacious, it will allow for the dissemination of this innovative treatment model to others working with children and adolescents with chronic pain.

Conditions

Pediatric Pain; Chronic Pain, Widespread; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Pain-related Fear and Avoidance

  Fear of Pain Questionnaire (FOPQ-C): a 24-item validated patient-report measure of pain-related fear and avoidance. The FOPQ-C contains two subscales: Fear of Pain (11 items; Min=0, Max=44) and Avoidance of Activities (13 items; Min=0, Max=52). Higher scores on each subscale indicate greater pain related fear and avoidance of activities.

  Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.

Secondary Outcomes (1)

• Functional Disability

  Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.

Study Arms (2)

Graded Exposure Therapy (GET Living)

EXPERIMENTAL

GET Living is jointly delivered by a pain psychologist and a physical therapist. The GET Living treatment was based on a published graded in-vivo exposure treatment manual for adults with adaptations to target a pediatric audience.

Behavioral: Graded Exposure Therapy (GET Living)

Multidisciplinary Pain Management (MPM)

ACTIVE COMPARATOR

MPM is a treatment intervention that is representative of current standards of care in a multidisciplinary pain clinic setting. It consists of Cognitive Behavioral Therapy (CBT) and Physical Therapy (PT) sessions, delivered separately by a pain psychologist and a physical therapist.

Behavioral: Multidisciplinary Pain Management (MPM)

Interventions

Graded Exposure Therapy (GET Living) BEHAVIORAL

The protocol consists of 12 interdisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Phase I-III are conducted with the psychologist, physical therapist, adolescent, and parent (as developmentally appropriate). Patient and parent will complete daily diaries and patients will wear the Actigraph throughout the duration of treatment.

Graded Exposure Therapy (GET Living)

Multidisciplinary Pain Management (MPM) BEHAVIORAL

The protocol consists of 12 multidisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Sessions will alternate between psychological CBT sessions and Physical Therapy sessions. Patient and parent will complete daily diaries and patients will wear the Actigraph throughout the duration of treatment. The parent will also participate in 3 additional parent-only sessions with the psychologist to address parental coping skills.

Multidisciplinary Pain Management (MPM)

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old; Male or Female
• Musculoskeletal pain (e.g. localized \[back, limb\], diffuse) not due to acute trauma (e.g. active sprain or fracture).
• Moderate to high pain-related fear ( ≥ 35 on the FOPQ-C)
• Moderate to high functional disability ( ≥ 13 on the FDI)
• English Language Proficiency

You may not qualify if:

• Significant cognitive impairment (e.g., brain injury)
• Significant medical or psychiatric problem that would interfere (e.g., seizures, psychosis, suicidality)

Sponsors & Collaborators

• Laura E Simons: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Pediatric Pain Management Clinic - Stanford Children's Health

Menlo Park, California, 94025, United States

Location

Related Publications (4)

• 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

• Shear D, Harrison LE, O'Brien S, Khazendar Z, Lyons S, Morgan JJ, Chan SK, Feinstein AB, Simons LE. Rapid Transition to Virtual Assessment and Treatment in an Interdisciplinary Randomized Clinical Trial for Youth With Chronic Pain: Adaptations and Implications for Future Trials. Clin J Pain. 2022 Jul 1;38(7):459-469. doi: 10.1097/AJP.0000000000001040.

  PMID: 35686576 RESULT

• Simons LE, Harrison LE, Boothroyd DB, Parvathinathan G, Van Orden AR, O'Brien SF, Schofield D, Kraindler J, Shrestha R, Vlaeyen JWS, Wicksell RK. A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain. Pain. 2024 Jan 1;165(1):177-191. doi: 10.1097/j.pain.0000000000003010. Epub 2023 Aug 25.

  PMID: 37624900 DERIVED

• Schemer L, Hess CW, Van Orden AR, Birnie KA, Harrison LE, Glombiewski JA, Simons LE. Enhancing Exposure Treatment for Youths With Chronic Pain: Co-design and Qualitative Approach. J Particip Med. 2023 Mar 9;15:e41292. doi: 10.2196/41292.

  PMID: 36892929 DERIVED

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Dr. Laura Simons
• Organization: Stanford University Medical School

lesimons@stanford.edu

(650) 736-0838

Study Officials

• Laura Simons, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Adolescents will be randomized to either GET Living or TPM and stratified on fear (moderate/high; FOPQ-C: moderate \[35-49\] high \[50-96\]) and disability (moderate/high; moderate \[13-29\] severe \[30-60\]), to minimize the possibility of imbalance between the two treatment arms. To allow the use of small blocks while minimizing the probability of a blinded staff member predicting the next assignment we will use blocks of size two and four and randomly choose block sizes.

Study Record Dates

• First Submitted: July 28, 2018
• First Posted: October 9, 2018
• Study Start: January 23, 2019
• Primary Completion: January 28, 2022
• Study Completion: January 28, 2022
• Last Updated: August 1, 2023
• Results First Posted: April 4, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Proposals should be directed to Dr. Laura Simons at lesimons@stanford.edu. To gain access, data requestors will need to sign a data usage agreement with Stanford University.

Locations

US (1)