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

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ClinicalTrials.gov Identifier: NCT03699007
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Laura E Simons, Stanford University

Tracking Information
First Submitted Date  ICMJE July 28, 2018
First Posted Date  ICMJE October 9, 2018
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE January 23, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
Pain-related Fear and Avoidance [ Time Frame: Baseline to end of treatment at 6-weeks, on average ]
Fear of Pain Questionnaire (FOPQ-C): a 24-item validated patient-report measure of pain-related fear and avoidance. (score Min=0, Max=96; Lower score means less fear and avoidance/better outcomes.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
Functional Disability [ Time Frame: Baseline to end of treatment at 6-weeks, on average ]
Functional Disability Inventory (FDI): a 15-item validated patient-report measure of difficulties in physical, social and recreational activities (score Min=0, Max=60; Lower score means less disability/better outcome)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
Official Title  ICMJE GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
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.
Detailed Description The treatment intervention to be tested in this clinical trial is Graded in-vivo Exposure Treatment (GET Living) compared to Typical Pain Management (TPM) in adolescents with chronic musculoskeletal pain. Participants will be randomized into GET Living or TPM, and will be instructed to not seek new treatments for pain for the duration of the study. Both treatments consist of 12 1-hour patient sessions delivered twice a week across 6- weeks and 3 parent-only sessions.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pediatric Pain
  • Chronic Pain, Widespread
  • Musculoskeletal Pain
Intervention  ICMJE
  • Behavioral: Graded Exposure Therapy (GET Living)
    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.
  • Behavioral: Typical Pain Management (TPM)
    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.
Study Arms  ICMJE
  • Experimental: Graded Exposure Therapy (GET Living)
    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.
    Intervention: Behavioral: Graded Exposure Therapy (GET Living)
  • Active Comparator: Typical Pain Management (TPM)
    TPM 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.
    Intervention: Behavioral: Typical Pain Management (TPM)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 4, 2018)
74
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 8 - 18 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

Exclusion Criteria:

  • Significant cognitive impairment (e.g., brain injury)
  • Significant medical or psychiatric problem that would interfere (e.g., seizures, psychosis, suicidality)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marissa Heirich, BS 650-723-5814 mheirich@stanford.edu
Contact: Gillian Rush, BA 650-497-9562 gqrush@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03699007
Other Study ID Numbers  ICMJE 39514
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Laura E Simons, Stanford University
Study Sponsor  ICMJE Laura E Simons
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laura Simons, PhD Associate Professor
PRS Account Stanford University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP