NCT04174326

CBT Program for Pain Management for Children and Youth With CP (CBT=Cognitive Behavioral Therapy; CP= Cerebral Palsy)

Cognitive Behavioral Pain Management Program for Children and Youth With Cerebral Palsy (CBPM_CP): a Feasibility Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Holland Bloorview Kids Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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 (50/50). The 2 groups are: (1) immediate treatment group and (2) delayed wait-list treatment group. 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 (QoL).One 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.

Conditions

• Cerebral Palsy
• Chronic Pain

Interventions

Type	Name	Description
BEHAVIORAL	Immediate intervention group	Participants will be randomized to either the immediate or delayed intervention group at baseline. Participants in both groups will receive CBT for chronic pain management sequentially, once a week during the 6 week intervention period. Participants will be followed-up at 18 weeks from baseline. Two in-between sessions practice assignments will be added to each group therapy session during the the CBT program.

Timeline

• Start date: 2020-08-24
• Primary completion: 2021-08-01
• Completion: 2021-12-01
• First posted: 2019-11-22
• Last updated: 2021-01-27

Locations

1 site across 1 country: Canada