GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03699007|
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : June 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Pain Chronic Pain, Widespread Musculoskeletal Pain||Behavioral: Graded Exposure Therapy (GET Living) Behavioral: Typical Pain Management (TPM)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|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.|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain|
|Actual Study Start Date :||January 23, 2019|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||December 2021|
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.
- Pain-related Fear and Avoidance [ Time Frame: 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.
- Functional Disability [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699007
|Contact: Marissa Heirich, BSfirstname.lastname@example.org|
|Contact: Gillian Rush, BAemail@example.com|
|United States, California|
|Pediatric Pain Management Clinic - Stanford Children's Health||Recruiting|
|Menlo Park, California, United States, 94025|
|Contact: Marissa Heirich, BS 650-723-5814 firstname.lastname@example.org|
|Contact: Gillian Rush, BA 650-497-9562 email@example.com|
|Principal Investigator: Laura E Simons, PhD|
|Principal Investigator:||Laura Simons, PhD||Associate Professor|