Pediatric PainNCT03699007

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

A study testing Graded Exposure Therapy (GET Living) and Multidisciplinary Pain Management (MPM) in people with Pediatric Pain and Chronic Pain, Widespread, run by Laura E Simons at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 8 to 18 years
Conditions the study is for: Pediatric Pain, Chronic Pain, Widespread, Musculoskeletal Pain
What is being tested?: Graded Exposure Therapy (GET Living) and Multidisciplinary Pain Management (MPM)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteUnited States
Study dates: 23 Jan 2019to 28 Jan 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Pediatric Pain Management Clinic - Stanford Children's Health
Menlo Park, California, 94025

Other trials in United States

About this study

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.

Read the 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: Pediatric Pain, Chronic Pain, Widespread, Musculoskeletal Pain
Being tested: Graded Exposure Therapy (GET Living), Multidisciplinary Pain Management (MPM)
Medical subject headings: Chronic Pain, Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Graded Exposure Therapy (GET Living)Behavioural
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.
Multidisciplinary Pain Management (MPM)Behavioural
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 groups in NCT03699007
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Multidisciplinary Pain Management (MPM)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jan 201928 Jan 2022

First posted9 Oct 2018
Study start23 Jan 2019
Primary completion28 Jan 2022
Study completion28 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Pediatric PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Outcomes assessor
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03699007
Sponsor's protocol ID: 39514
Other IDs: 1R21AR072921-01A1
Status last verified: Jul 2023
First submitted: 28 Jul 2018
Last updated: 1 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data (text, tables, figures, appendices) that underlie the results reported in an article related to this trial will, after de-identification, be shared with researchers who provide a methodologically sound proposal.

Publications

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.
PubMed 31650069
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.
PubMed 35686576
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.
PubMed 37624900
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.
PubMed 36892929

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
ClinicalTrials.gov ID: NCT03699007
Acronym / sponsor ID: 39514
Conditions: Pediatric Pain, Chronic Pain, Widespread, Musculoskeletal Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Laura E SimonsUniversity, hospital or other
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study start: 23 Jan 2019 (actual)
Primary completion: 28 Jan 2022 (actual)
Study completion: 28 Jan 2022 (actual)
First posted: 9 Oct 2018 (actual)
Results: Posted 4 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Graded Exposure Therapy (GET Living)	Experimental	Behavioral: 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.
Multidisciplinary Pain Management (MPM)	Active comparator	Behavioral: Multidisciplinary Pain Management (MPM)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.

Who may qualify

Ages: 8 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Graded Exposure Therapy (GET Living)
Multidisciplinary 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.	Behavioural	Multidisciplinary Pain Management (MPM)

Primary outcome

Pain-related Fear and Avoidance
Time frame: Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.
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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 4 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Graded Exposure Therapy (GET Living)	33	26
Multidisciplinary Pain Management (MPM)	35	33

Primary outcome: Pain-related Fear and Avoidance

Time frame: Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.. Mean (Standard Deviation). Unit: score on a scale

Measure	Graded Exposure Therapy (GET Living) n = 33	Multidisciplinary Pain Management (MPM) n = 35
Fear of Pain_Baseline	32.36 (8.83)	30.03 (9.59)
Fear of Pain_Discharge	25.15 (9.14)	25.64 (10.64)
Fear of Pain_3 month follow-up	22.24 (11.53)	20.03 (11.54)
Fear of Pain_6 month follow-up	20.17 (11.25)	21.15 (12.78)
Avoidance of Activities_Baseline	26.67 (8.59)	25.06 (8.71)
Avoidance of Activities_Discharge	20.81 (8.66)	21.61 (8.72)
Avoidance of Activities_3 month follow-up	18.92 (10.75)	18.73 (9.89)
Avoidance of Activities_6 month follow-up	18.61 (10.81)	16.77 (9.63)

Graded Exposure Therapy (GET Living) vs Multidisciplinary Pain Management (MPM): p <0.05, Mixed Models Analysis

Population analysed: Participants with data available at each time point are included in the analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were identified from signing of ICF to end of treatment, an average duration of 6 weeks. During the 3 month and 6 month follow-up contacts, the study staff asked patient and parent if any AEs occurred since the end of treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Graded Exposure Therapy (GET Living)	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Typical Pain Management (TPM)	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31650069Simons 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.
Results publication: PubMed 35686576Shear 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.
Derived from this study: PubMed 37624900Simons 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.
Derived from this study: PubMed 36892929Schemer 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.
Individual participant dataSharing planned: Yes. Individual participant data (text, tables, figures, appendices) that underlie the results reported in an article related to this trial will, after de-identification, be shared with researchers who provide a methodologically sound proposal.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura Simons, PhD principal investigator

Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain-related Fear and Avoidance (time frame: Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03699007, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.