Clinical Trials Directory

Trials / Completed

CompletedNCT03699007

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
68 (actual)
Sponsor
Laura E Simons · Academic / Other
Sex
All
Age
8 Years – 18 Years
Healthy volunteers
Not accepted

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 Multidisciplinary Pain Management (MPM) in adolescents with chronic musculoskeletal pain. Participants will be randomized into GET Living or MPM, 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALGraded 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.
BEHAVIORALMultidisciplinary Pain Management (MPM)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.

Timeline

Start date
2019-01-23
Primary completion
2022-01-28
Completion
2022-01-28
First posted
2018-10-09
Last updated
2023-08-01
Results posted
2023-04-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03699007. Inclusion in this directory is not an endorsement.