Trial Outcomes & Findings for GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain (NCT NCT03699007)
NCT ID: NCT03699007
Last Updated: 2023-08-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.
Results posted on
2023-08-01
Participant Flow
Participant milestones
| Measure |
Graded Exposure Therapy (GET Living)
Graded Exposure Therapy (GET Living) is jointly delivered by a pain psychologist and a physical therapist: 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).
|
Multidisciplinary Pain Management (MPM)
Multidisciplinary Pain Management (MPM) protocol consists of 12 multidisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Sessions will alternate between psychological Cognitive Behavioral Therapy (CBT) sessions and Physical Therapy sessions. The parent will also participate in 3 additional parent-only sessions with the psychologist to address parental coping skills.
|
|---|---|---|
|
Treatment Phase (Baseline to 3-Month FU)
STARTED
|
33
|
35
|
|
Treatment Phase (Baseline to 3-Month FU)
COMPLETED
|
26
|
33
|
|
Treatment Phase (Baseline to 3-Month FU)
NOT COMPLETED
|
7
|
2
|
|
6-month Follow Up
STARTED
|
26
|
33
|
|
6-month Follow Up
COMPLETED
|
24
|
30
|
|
6-month Follow Up
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Graded Exposure Therapy (GET Living)
Graded Exposure Therapy (GET Living) is jointly delivered by a pain psychologist and a physical therapist: 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).
|
Multidisciplinary Pain Management (MPM)
Multidisciplinary Pain Management (MPM) protocol consists of 12 multidisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Sessions will alternate between psychological Cognitive Behavioral Therapy (CBT) sessions and Physical Therapy sessions. The parent will also participate in 3 additional parent-only sessions with the psychologist to address parental coping skills.
|
|---|---|---|
|
Treatment Phase (Baseline to 3-Month FU)
Physician Decision
|
7
|
2
|
|
6-month Follow Up
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
Baseline characteristics by cohort
| Measure |
Graded Exposure Therapy (GET Living)
n=33 Participants
Graded Exposure Therapy (GET Living) is jointly delivered by a pain psychologist and a physical therapist: 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).
|
Multidisciplinary Pain Management (MPM)
n=35 Participants
Multidisciplinary Pain Management (MPM) 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. The parent will also participate in 3 additional parent-only sessions with the psychologist to address parental coping skills.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
33 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
14.1 years
STANDARD_DEVIATION 2.92 • n=93 Participants
|
14.2 years
STANDARD_DEVIATION 2.24 • n=4 Participants
|
14.1 years
STANDARD_DEVIATION 2.57 • n=27 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Fear of Pain
|
32.36 score on a scale
STANDARD_DEVIATION 8.83 • n=93 Participants
|
30.03 score on a scale
STANDARD_DEVIATION 9.59 • n=4 Participants
|
31.16 score on a scale
STANDARD_DEVIATION 9.24 • n=27 Participants
|
|
Avoidance of Activities
|
26.67 score on a scale
STANDARD_DEVIATION 8.59 • n=93 Participants
|
25.06 score on a scale
STANDARD_DEVIATION 8.71 • n=4 Participants
|
25.84 score on a scale
STANDARD_DEVIATION 8.63 • n=27 Participants
|
|
FDI
|
25.06 score on a scale
STANDARD_DEVIATION 10.26 • n=93 Participants
|
27 score on a scale
STANDARD_DEVIATION 9.35 • n=4 Participants
|
25.90 score on a scale
STANDARD_DEVIATION 9.68 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.Population: Participants with data available at each time point are included in the analysis.
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.
Outcome measures
| Measure |
Graded Exposure Therapy (GET Living)
n=33 Participants
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.
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.
|
Multidisciplinary Pain Management (MPM)
n=35 Participants
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.
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.
|
|---|---|---|
|
Pain-related Fear and Avoidance
Fear of Pain_Baseline
|
32.36 score on a scale
Standard Deviation 8.83
|
30.03 score on a scale
Standard Deviation 9.59
|
|
Pain-related Fear and Avoidance
Fear of Pain_Discharge
|
25.15 score on a scale
Standard Deviation 9.14
|
25.64 score on a scale
Standard Deviation 10.64
|
|
Pain-related Fear and Avoidance
Fear of Pain_3 month follow-up
|
22.24 score on a scale
Standard Deviation 11.53
|
20.03 score on a scale
Standard Deviation 11.54
|
|
Pain-related Fear and Avoidance
Fear of Pain_6 month follow-up
|
20.17 score on a scale
Standard Deviation 11.25
|
21.15 score on a scale
Standard Deviation 12.78
|
|
Pain-related Fear and Avoidance
Avoidance of Activities_Baseline
|
26.67 score on a scale
Standard Deviation 8.59
|
25.06 score on a scale
Standard Deviation 8.71
|
|
Pain-related Fear and Avoidance
Avoidance of Activities_Discharge
|
20.81 score on a scale
Standard Deviation 8.66
|
21.61 score on a scale
Standard Deviation 8.72
|
|
Pain-related Fear and Avoidance
Avoidance of Activities_3 month follow-up
|
18.92 score on a scale
Standard Deviation 10.75
|
18.73 score on a scale
Standard Deviation 9.89
|
|
Pain-related Fear and Avoidance
Avoidance of Activities_6 month follow-up
|
18.61 score on a scale
Standard Deviation 10.81
|
16.77 score on a scale
Standard Deviation 9.63
|
SECONDARY outcome
Timeframe: Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.Population: Participants with data available at each time point are included in the analysis.
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)
Outcome measures
| Measure |
Graded Exposure Therapy (GET Living)
n=33 Participants
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.
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.
|
Multidisciplinary Pain Management (MPM)
n=33 Participants
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.
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.
|
|---|---|---|
|
Functional Disability
Baseline
|
25.06 score on a scale
Standard Deviation 10.26
|
27 score on a scale
Standard Deviation 9.35
|
|
Functional Disability
Discharge (approx. week 6)
|
20.59 score on a scale
Standard Deviation 10.45
|
22 score on a scale
Standard Deviation 9.58
|
|
Functional Disability
3-month Follow Up
|
20.08 score on a scale
Standard Deviation 12.75
|
19.24 score on a scale
Standard Deviation 10.08
|
|
Functional Disability
6-month Follow Up
|
19.82 score on a scale
Standard Deviation 13.21
|
19.62 score on a scale
Standard Deviation 12.28
|
Adverse Events
Graded Exposure Therapy (GET Living)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Typical Pain Management (TPM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place