Ignite Creation Date:
2024-05-06 @ 1:28 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01813669
Status:
COMPLETED
Last Update Posted:
2014-08-20
First Post:
2013-03-15
Brief Title:
Integrative Coping Group for Children
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Treatment of Psychosomatic Pain in Youth ToPSY A Pilot Study
Status:
COMPLETED
Status Verified Date:
2014-08
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:
ToPSY
Brief Summary:
The purpose of this study is to examine whether an integrative group-based intervention will help children experiencing psychological and physical distress Children ages 10 to 12 will be recruited for participation in this therapeutic group Eligible and consenting participants will be randomized to a wait-list control group or the group intervention The group intervention will take place over a 12-week period during which participants will attend a weekly coping skills group that integrates yoga-based practices such as yoga poses mindfulness self-acceptance breath work with cognitive-behavioral principles such as increasing awareness of thoughts and emotions
Detailed Description:
Psychosomatic symptoms are physical complaints in the absence of an organic cause For children and adolescents psychosomatic symptoms often manifest as headaches gastrointestinal GI discomfort non-specific musculoskeletal pain and fatigue These symptoms are strongly associated with the presence of an internalizing disorder-namely anxiety or depression-in youth Thus treatment of these symptoms has often been cached within a broader intervention protocol the overarching goal of which is to address the global internalizing disorder For children who experience intense and persistent psychosomatic discomfort however it can be critical to specifically target these symptoms through intensive intervention Otherwise psychosomatic complaints can be extremely impairing impeding childrens attendance in school participation in extracurricular activities and disrupting family activities At present there are few systematic that can target a range of psychosomatic problems
Yoga-based interventions may be a particularly valuable treatment for children with psychosomatic complaints Such interventions have been studied empirically in adults with a number of psychosomatic conditions and more recently in children with a variety of psychological conditions Indeed there have been a small number of studies targeting psychosomatic complaints in children via yogic practices Although there is emerging interest in yoga-based interventions for youth and slowly growing evidence their efficacy at present there are no known structured interventions for youth with psychosomatic complaints in the context of an internalizing disorder Thus the goal of the present proposal is to develop a semi-structured manualized intervention that targets impairing psychosomatic symptoms in youth with a comorbid internalizing disorders The specific aims are as follows
Specific Aim 1 Treatment Feasibility Assess the feasibility of a novel integrative coping intervention for children with somatic symptoms and anxiety
Hypothesis The yoga-based intervention will be acceptable and feasible for children Acceptability will be defined as a 50 consent rate among participants approached for the study Feasibility will be defined by 75 of children completing 80 of intervention sessions
Secondary Aim 1 Treatment Efficacy Assess the preliminary efficacy of a 12-week integrative coping intervention on both somatic and psychological eg anxiety mood symptoms compared to a wait-list control condition
Hypothesis Children in the active intervention condition will have a significant reduction in somatic and anxiety symptoms following the 12-week intervention compared to a wait-list control
Yoga-based interventions may be a particularly valuable treatment for children with psychosomatic complaints Such interventions have been studied empirically in adults with a number of psychosomatic conditions and more recently in children with a variety of psychological conditions Indeed there have been a small number of studies targeting psychosomatic complaints in children via yogic practices Although there is emerging interest in yoga-based interventions for youth and slowly growing evidence their efficacy at present there are no known structured interventions for youth with psychosomatic complaints in the context of an internalizing disorder Thus the goal of the present proposal is to develop a semi-structured manualized intervention that targets impairing psychosomatic symptoms in youth with a comorbid internalizing disorders The specific aims are as follows
Specific Aim 1 Treatment Feasibility Assess the feasibility of a novel integrative coping intervention for children with somatic symptoms and anxiety
Hypothesis The yoga-based intervention will be acceptable and feasible for children Acceptability will be defined as a 50 consent rate among participants approached for the study Feasibility will be defined by 75 of children completing 80 of intervention sessions
Secondary Aim 1 Treatment Efficacy Assess the preliminary efficacy of a 12-week integrative coping intervention on both somatic and psychological eg anxiety mood symptoms compared to a wait-list control condition
Hypothesis Children in the active intervention condition will have a significant reduction in somatic and anxiety symptoms following the 12-week intervention compared to a wait-list control
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