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

Sponsor

Laura E Simons (Other)

Overall Status

Completed

CT.gov ID

NCT03699007

Collaborator

(none)

Enrollment

Location

Arms

36.2

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Pain Chronic Pain, Widespread Musculoskeletal Pain	Behavioral: Graded Exposure Therapy (GET Living) Behavioral: Typical Pain Management (TPM)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

68 participants

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.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

Official Title:

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

Actual Study Start Date :

Jan 23, 2019

Actual Primary Completion Date :

Jan 28, 2022

Actual Study Completion Date :

Jan 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.	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.

Arm

Intervention/Treatment

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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

Pain-related Fear and Avoidance [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.

Secondary Outcome Measures

Functional Disability [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pediatric Pain Management Clinic - Stanford Children's Health	Menlo Park	California	United States	94025

Sponsors and Collaborators

Laura E Simons

Investigators

Principal Investigator: Laura Simons, PhD, Professor

Study Documents (Full-Text)

Informed Consent Form - Mar 4, 2021

More Information

Publications

None provided.

Responsible Party:

Laura E Simons, Associate Professor, Stanford University

ClinicalTrials.gov Identifier:

NCT03699007

Other Study ID Numbers:

39514

First Posted:

Oct 9, 2018

Last Update Posted:

Jul 14, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Musculoskeletal Pain

Chronic Pain

Study Results

No Results Posted as of Jul 14, 2022