Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01381263
Status:
COMPLETED
Last Update Posted:
2018-05-25
First Post:
2010-12-20
Brief Title:
Behavioral Medicine Treatment for Adolescents in Pain
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
Development Evaluation and Cost Effectiveness of a Treatment Program With a Behavioural Medicine Approach for Adolescents With Persistent Pain
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
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:
None
Brief Summary:
Recurrent pain such as headache stomach pain and musculoskeletal pain is common in children and adolescents Children and adolescents are reported to have restrictions in daily life activities social contacts and school attendance and to have poorer academic skills and as well as an increased utilization of heath care services due to pain problems The treatment approaches available today for teenagers with pain are often biologicalphysiological and little evidence for their effectiveness has been shown It is urgent to try new interventions for pain problems in early ages in order to prevent disability development of maladaptive coping strategies and to avoid negative impact on daily activities
The optimal treatment regime for paediatric pain patients has been suggested to be cognitive behavioural approach integrated with physical therapy The aim of this project is to develop and evaluate in a randomized controlled trial a treatment program with a behavioural medicine approach suitable to use in primary care or school based health care context compared with standard treatment for adolescents with persistent pain problems The aim is also to compare short and long-term costs for patients and for the health care system related to the two interventions in order to determine strategies for future cost-effective care of children and adolescents experiencing recurrent pain
The optimal treatment regime for paediatric pain patients has been suggested to be cognitive behavioural approach integrated with physical therapy The aim of this project is to develop and evaluate in a randomized controlled trial a treatment program with a behavioural medicine approach suitable to use in primary care or school based health care context compared with standard treatment for adolescents with persistent pain problems The aim is also to compare short and long-term costs for patients and for the health care system related to the two interventions in order to determine strategies for future cost-effective care of children and adolescents experiencing recurrent pain
Detailed Description:
Chronic or recurrent pain symptoms are widely studied and generally regarded as an important public health concern in adults The prevalence of pain symptoms are reported to be as high as 25-30 in children and adolescents Children and adolescents are reported to have restrictions in daily life activities social contacts and school attendance and to have poorer academic skills and as well as an increased utilization of heath care services due to pain problems These patients suffer from a wide variety of problems for example sports injuries persistent postoperative pain musculoskeletal pains headaches or multiple recurrent pain problems The treatments given today to adolescents are dealing with symptoms in a physical manner
In this study participants will be recruited among adolescents referred to paediatric physiotherapy The participants will be randomly allocated to either physiotherapy including standard treatment or a behavioural medicine treatment program Standard treatment includes muscle strengthening stretching posture training training of relaxation techniques and information about pain according to the best empirical praxis
The behavioural medicine treatment program will include the same components as the standard treatment with the addition of age appropriate interventions aimed to address the emotional and behavioural processes of pain The treatment is based on earlier intervention programs and includes the following phases
Individual functional behavioural analysis The adolescents lists specific important and frequent activities and situations they have problems to master due to pain and target activities are then chosen Individual capabilities both physical and psychological behavioural responses and their short and long-term consequences are identified Parental responses and their impact on adolescents pain behaviours are noted Target activity related treatment goals as well goals for engagement in the treatment are defined from the individual functional behavioural analysis
Basic skill acquisition Physical abilities and cognitive skills required for improvement of behaviour in target activities are trained For example to meet the problem of fear of movement graded activity or exposure will be provided When negative thoughts are recognized the adolescents are taught and trained on how to replace these thoughts self-efficacy for target activities are increased by carefully selected activities witch allows the adolescent to succeed and by repeated feedback from the physiotherapists Adequate coping strategies for restoring and sustaining activities are taught and trained Parents are trained on how to support new behaviours
Applied skill acquisition The basic capabilities are put together in order to shape the more complex skills required when applying in target activities Self- efficacy is reinforced by feedback from both the physiotherapists and parents
Generalisation This phase includes the generalisation of new both physical and psychological skills to other for the adolescent important activities
Maintenance and relapse prevention This phase includes the identification of risk situations and recognition of how adolescents and parents can support positive behaviours further
Patient follow-ups takes place immediately after completed intervention after 6 months and after one year and two years after intervention in order to evaluate the long-term effect
Parents The treatment is based on earlier intervention program and includes Information on pain and pain behaviours and parental impact on adolescents pain behaviours An individual intervention plan according to each teenagers problems is made All parents will be trained on how to support new positive health behaviours
In this study participants will be recruited among adolescents referred to paediatric physiotherapy The participants will be randomly allocated to either physiotherapy including standard treatment or a behavioural medicine treatment program Standard treatment includes muscle strengthening stretching posture training training of relaxation techniques and information about pain according to the best empirical praxis
The behavioural medicine treatment program will include the same components as the standard treatment with the addition of age appropriate interventions aimed to address the emotional and behavioural processes of pain The treatment is based on earlier intervention programs and includes the following phases
Individual functional behavioural analysis The adolescents lists specific important and frequent activities and situations they have problems to master due to pain and target activities are then chosen Individual capabilities both physical and psychological behavioural responses and their short and long-term consequences are identified Parental responses and their impact on adolescents pain behaviours are noted Target activity related treatment goals as well goals for engagement in the treatment are defined from the individual functional behavioural analysis
Basic skill acquisition Physical abilities and cognitive skills required for improvement of behaviour in target activities are trained For example to meet the problem of fear of movement graded activity or exposure will be provided When negative thoughts are recognized the adolescents are taught and trained on how to replace these thoughts self-efficacy for target activities are increased by carefully selected activities witch allows the adolescent to succeed and by repeated feedback from the physiotherapists Adequate coping strategies for restoring and sustaining activities are taught and trained Parents are trained on how to support new behaviours
Applied skill acquisition The basic capabilities are put together in order to shape the more complex skills required when applying in target activities Self- efficacy is reinforced by feedback from both the physiotherapists and parents
Generalisation This phase includes the generalisation of new both physical and psychological skills to other for the adolescent important activities
Maintenance and relapse prevention This phase includes the identification of risk situations and recognition of how adolescents and parents can support positive behaviours further
Patient follow-ups takes place immediately after completed intervention after 6 months and after one year and two years after intervention in order to evaluate the long-term effect
Parents The treatment is based on earlier intervention program and includes Information on pain and pain behaviours and parental impact on adolescents pain behaviours An individual intervention plan according to each teenagers problems is made All parents will be trained on how to support new positive health behaviours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None