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

NCT ID: NCT04174326

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-24
• Study Completion Date: 2021-12-31

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 (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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

A weekly 2 hour CBT for chronic pain group intervention for a duration of 6 weeks

Group Type: EXPERIMENTAL

Immediate intervention group

Intervention Type: BEHAVIORAL

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.

Delayed intervention group

A waiting list for CBT for chronic pain group intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Immediate

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Holland Bloorview Kids Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darcy Fehlings, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Holland Bloorview Kids Rehabilitation Hospital

Locations

Holland-Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

REB19-850

Identifier Type: -

Identifier Source: org_study_id