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Web-based CBT for Children With Chronic Pain

Primary Purpose

Chronic Pain, Headache, Abdominal Pain

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
cognitive-behavioral therapy
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring cognitive-behavioral therapy, chronic pain, randomized controlled trial, pediatrics

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic headache, abdominal, and/or musculoskeletal pain present over the previous 3 months
  • interference from pain in at least one area of daily functioning.

Exclusion Criteria:

  • serious comorbid chronic condition in the patient (e.g., diabetes, cancer)
  • non-English speaking
  • previous participation in cognitive-behavioral therapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    CBT

    SMC

    Arm Description

    Cognitive-behavioral therapy delivered via the internet in eight treatment modules for children (education, stress and negative emotions, deep breathing and relaxation, distraction, cognitive skills, sleep hygiene and lifestyle, staying active, relapse prevention) and eight treatment modules for parents (education, stress and negative emotions, operant strategies I, operant strategies II, modeling, sleep hygiene and lifestyle, communication, relapse prevention).

    The standard medical care wait-list control group continued with the treatment recommendations proscribed by their pain care team.

    Outcomes

    Primary Outcome Measures

    activity limitations

    Secondary Outcome Measures

    parental response to pain behaviors
    depressive symptoms
    pain intensity

    Full Information

    First Posted
    February 26, 2009
    Last Updated
    May 26, 2015
    Sponsor
    Seattle Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00853138
    Brief Title
    Web-based CBT for Children With Chronic Pain
    Official Title
    Web-based CBT for Children With Chronic Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2007 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    May 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seattle Children's Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to develop and evaluate the feasibility and effectiveness of a web-based (i.e., internet) treatment approach for providing psychological treatment to reduce pain and improve functioning in children and adolescents with chronic pain.
    Detailed Description
    Chronic pain is an important problem for children and adolescents owing to its high prevalence rate and significant impact on children's mood, daily functioning, and overall quality of life. Effective psychological treatments have been developed to change behaviors and thoughts important in the child's ability to cope with chronic pain. However, the majority of children do not have access to these treatments due to a variety of barriers such as geographical distance from pediatric pain treatment centers. The purpose of this study is to develop a more accessible method of delivering effective psychological treatment to reduce pain and increase function in children. Children with chronic headache, abdominal, or musculoskeletal pain will be randomized to either receive the web-based treatment right away or to be in a wait-list control condition and receive the treatment 8 weeks later. Both groups of children will continue to receive clinical care through specialty medical clinics. Children's level of pain, their ability to perform, daily functional activities, and overall quality of life will be evaluated before treatment begins, immediately after treatment, and at a 3 month follow up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain, Headache, Abdominal Pain
    Keywords
    cognitive-behavioral therapy, chronic pain, randomized controlled trial, pediatrics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CBT
    Arm Type
    Experimental
    Arm Description
    Cognitive-behavioral therapy delivered via the internet in eight treatment modules for children (education, stress and negative emotions, deep breathing and relaxation, distraction, cognitive skills, sleep hygiene and lifestyle, staying active, relapse prevention) and eight treatment modules for parents (education, stress and negative emotions, operant strategies I, operant strategies II, modeling, sleep hygiene and lifestyle, communication, relapse prevention).
    Arm Title
    SMC
    Arm Type
    No Intervention
    Arm Description
    The standard medical care wait-list control group continued with the treatment recommendations proscribed by their pain care team.
    Intervention Type
    Behavioral
    Intervention Name(s)
    cognitive-behavioral therapy
    Intervention Description
    In addition to standard medical care, the children and parents in the family CBT condition will also receive education about chronic pain, pain behaviors and operant strategies as well as training in coping skills using an interactive, engaging format on the Internet. The Internet site will consist of three main sections: child treatment modules, parent treatment modules, and diary tracking. All users will complete 8 treatment modules (one per week) over the 8-week treatment period. Each module will require approximately 30-40 minutes to complete. There is separate specific content of the intervention for child users and for parent users. Assignments are incorporated into each module for the participant to work on during the treatment week.
    Primary Outcome Measure Information:
    Title
    activity limitations
    Time Frame
    immediately post-treatment, 3 month follow-up
    Secondary Outcome Measure Information:
    Title
    parental response to pain behaviors
    Time Frame
    immediately post-treatment, 3 month follow-up
    Title
    depressive symptoms
    Time Frame
    immediately post-treatment, 3 month follow-up
    Title
    pain intensity
    Time Frame
    immediately post-treatment, 3 month follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: chronic headache, abdominal, and/or musculoskeletal pain present over the previous 3 months interference from pain in at least one area of daily functioning. Exclusion Criteria: serious comorbid chronic condition in the patient (e.g., diabetes, cancer) non-English speaking previous participation in cognitive-behavioral therapy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tonya M Palermo, PhD
    Organizational Affiliation
    Seattle Children's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19695776
    Citation
    Palermo TM, Wilson AC, Peters M, Lewandowski A, Somhegyi H. Randomized controlled trial of an Internet-delivered family cognitive-behavioral therapy intervention for children and adolescents with chronic pain. Pain. 2009 Nov;146(1-2):205-13. doi: 10.1016/j.pain.2009.07.034. Epub 2009 Aug 19.
    Results Reference
    result
    PubMed Identifier
    22511033
    Citation
    Law EF, Murphy LK, Palermo TM. Evaluating treatment participation in an internet-based behavioral intervention for pediatric chronic pain. J Pediatr Psychol. 2012 Sep;37(8):893-903. doi: 10.1093/jpepsy/jss057. Epub 2012 Apr 17.
    Results Reference
    result

    Learn more about this trial

    Web-based CBT for Children With Chronic Pain

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