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

H

Holland Bloorview Kids Rehabilitation Hospital

Status

Unknown

Conditions

Chronic Pain
Cerebral Palsy

Treatments

Behavioral: Immediate intervention group

Study type

Interventional

Funder types

Other

Identifiers

NCT04174326
REB19-850

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

8 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Diagnosis of CP
  2. Chronic pain lasting greater than 3 months and restricting some or all activities according to child/youth/parental self-report
  3. A baseline score of 70 (~ -2 SD) on each of the three vineland adaptive behavior scales (VABS) sub-scales: communication, daily living skills and socialization
  4. Successful completion of a modified sorting task including sorting cubes according to size and rating activities in order of how much they like to do them
  5. Parent agreement to participate in the parents' program
  6. Can communicate in English, with or without the use of augmentative communication devices

Exclusion criteria

Participants who meet any of the following criteria will not be eligible to take part in the trial:

  1. Diagnosis of major visual or hearing impairment
  2. Currently attending psychological treatment focused on pain management; (3) Uncontrolled seizure(s) (with or without medication) in the previous 12 months.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

8 participants in 2 patient groups

Intervention group
Experimental group
Description:
A weekly 2 hour CBT for chronic pain group intervention for a duration of 6 weeks
Treatment:
Behavioral: Immediate intervention group
Delayed intervention group
No Intervention group
Description:
A waiting list for CBT for chronic pain group intervention.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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