Ignite Creation Date:
2024-05-06 @ 1:58 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04174326
Status:
UNKNOWN
Last Update Posted:
2021-01-27
First Post:
2019-11-20
Brief Title:
CBT Program for Pain Management for Children and Youth With CP CBTCognitive Behavioral Therapy CP Cerebral Palsy
Sponsor:
Holland Bloorview Kids Rehabilitation Hospital
Organization:
Holland Bloorview Kids Rehabilitation Hospital
Study Overview
Official Title:
Cognitive Behavioral Pain Management Program for Children and Youth With Cerebral Palsy CBPM_CP a Feasibility Study
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBTCP
Brief Summary:
This study will focus on the feasibility of a modified cognitive behavioral program for pain management among children and youth with cerebral palsy CP on developing pain coping skills and reducing pain interference levels The study design is a randomized control feasibility trial Participants will be placed randomly into one of two groups based on chance 5050 The 2 groups are 1 immediate treatment group and 2 delayed wait-list treatment group
Both groups will receive the same intervention protocol
Both groups will receive the same intervention protocol
Detailed Description:
Children with CP often experience pain that is related to their medical condition and that may limit or interfere with their everyday activities and Quality of Life QoLOne possible way to help these children is by using a modified cognitive behavioral therapy CBT for pain management
For this study the investigators want to do a feasibility study to see if participating in a six-week pain management CBT program for children and youth with CP and their parents leads to better pain coping skills and lower levels of pain interference when compared to a controlled waiting list
Participants in both groups immediate and delayed treatment will participate in a 2-hour CBT session once a week for a total of six weeks Following 3-months from the last CBT session participants will be contacted for a short follow-up screening All participants will be enrolled in the study for a total of 18 weeks
This study will be done at the Holland Bloorview Kids Rehabilitation Hospital Toronto Canada Sixteen participants with CP gross motor function classification system GMFCS levels I-V age 8 to 18 with evidence of chronic pain detailed as pain lasting more than 3 months or lasting longer than the expected time to heal and their parents will be recruited for participation
For this study the investigators want to do a feasibility study to see if participating in a six-week pain management CBT program for children and youth with CP and their parents leads to better pain coping skills and lower levels of pain interference when compared to a controlled waiting list
Participants in both groups immediate and delayed treatment will participate in a 2-hour CBT session once a week for a total of six weeks Following 3-months from the last CBT session participants will be contacted for a short follow-up screening All participants will be enrolled in the study for a total of 18 weeks
This study will be done at the Holland Bloorview Kids Rehabilitation Hospital Toronto Canada Sixteen participants with CP gross motor function classification system GMFCS levels I-V age 8 to 18 with evidence of chronic pain detailed as pain lasting more than 3 months or lasting longer than the expected time to heal and their parents will be recruited for participation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None