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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Children's Hospital Boston
Information provided by (Responsible Party):
Laura Simons(Giardi), Children's Hospital Boston Identifier:
First received: October 22, 2013
Last updated: January 26, 2016
Last verified: January 2016
The broad aim of the 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. Pain-related fear is an important psychological factor associated with poor outcomes in children suffering with chronic pain. To examine the efficacy of GET Living in addressing pain-related fears the investigators propose to use a sequential replicated randomized single-case experimental phase design with multiple measures. The specific aims are to 1) evaluate the effectiveness and acceptability of individually tailored GET Living for children with high pain-related fear and functional disability and 2) define anatomical and resting state connectivity patterns in the brains of children and adolescents with complex chronic pain prior to and after participation in GET Living.

Condition Intervention
Chronic Pain
Musculoskeletal Pain
Behavioral: GET Living
Other: Multidisciplinary Standard Care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain

Resource links provided by NLM:

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Decrease in Fear of Pain [ Time Frame: Decrease in Fear of Pain from Baseline to end of treatment at 6-weeks, on average ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease in Functional Disability [ Time Frame: Decrease in Functional Disability from Baseline to end of treatment at 6-weeks, on average ] [ Designated as safety issue: No ]
  • Improvement in School Functioning [ Time Frame: Improvement in School Functioning from baseline to end of treatment at 6-weeks, on average ] [ Designated as safety issue: No ]
  • Decrease in Pain Catastrophizing [ Time Frame: Decrease in Pain Catastrophizing from baseline to end of treatment at 6-weeks, on average ] [ Designated as safety issue: No ]
  • Decrease in Pain Intensity [ Time Frame: Decrease in Pain Intensity from baseline to end of treatment at 6-weeks, on average ] [ Designated as safety issue: No ]
  • Increase in Physical Activity [ Time Frame: Increase in Physical Activity from baseline to end of treatment at 6-weeks, on average ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: October 2013
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GET Living Treatment Behavioral: GET Living
GET Living is an exposure based treatment jointly delivered by a cognitive-behavioral therapist and physical therapy to help children and adolescents suffering with chronic pain and headache progressively return to valued life activities.
Active Comparator: Multidisciplinary Standard Care Other: Multidisciplinary Standard Care
Patients who are evaluated at the Pain Treatment Service are given recommendations that include medical, physical therapy, and psychological treatments.


Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pain-related fear (score >40 on the Fear of Pain Questionnaire (FOPQ (Simons et al., 2011a))
  • Musculoskeletal, neuropathic limb or back pain, or headache
  • Functional limitations (score > 12 on the Functional Disability Inventory (FDI (Kashikar-Zuck et al., 2001; Walker and Greene, 1991)).

Exclusion Criteria:

  • Significant cognitive impairment (e.g., intellectual disability)
  • Serious psychopathology (e.g., active suicidality).
  • Acute trauma (e.g., spondylolithesis, disk herniation, fracture, acute tendonitis)
  • Systemic disease in active inflammatory state
  • Biomechanical deficit that would limit ability to engage in exposure activities (e.g. severe muscle atrophy)
  • Making gains in current physical therapy or have not had physical therapy, but it is clearly indicated
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01974791

Contact: Molly Basch 617-919-4676
Contact: Laura Simons 617-919-4677

United States, Massachusetts
Boston Children's Hospital Waltham Recruiting
Waltham, Massachusetts, United States, 02453
Principal Investigator: Laura Simons, PhD         
Sponsors and Collaborators
Children's Hospital Boston
Principal Investigator: Laura E Simons, PhD Children's Hospital Boston
  More Information

Responsible Party: Laura Simons(Giardi), Staff Psychologist, Children's Hospital Boston Identifier: NCT01974791     History of Changes
Other Study ID Numbers: IRB-P00007276  82267 
Study First Received: October 22, 2013
Last Updated: January 26, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chronic Pain
Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on May 26, 2016