Terminé

ToPSYTreatment of Psychosomatic Pain in Youth (ToPSY): A Pilot Study

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Ce qui est testé

Integrative Coping Group

Comportemental
Qui peut participer

Troubles Mentaux+14

+ Maladies du cerveau

+ Maladies du système nerveux central

De 10 à 12 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Interventionnel
Date de début : octobre 2012
Voir le détail du protocole

Résumé

Sponsor principalDuke University
Dernière mise à jour : 20 août 2014
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 octobre 2012

Date à laquelle le premier participant a commencé l'étude.

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 children's 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 (e.g., 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.

Sponsor principalDuke University
Dernière mise à jour : 20 août 2014
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

28 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 10 à 12 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Troubles MentauxMaladies du cerveauMaladies du système nerveux centralMaladies musculairesMaladies musculo-squelettiquesMaladies du système nerveuxManifestations NeurologiquesDouleurSignes et symptômesConditions pathologiques, signes et symptômesTroubles du déficit de l'attention et du comportement perturbateurTroubles de la céphaléeTroubles de la céphalée primaireTroubles du développement neurologiqueTrouble Déficit de l'Attention avec HyperactivitéTroubles de la MigraineDouleur musculosquelettique

Critères

Inclusion Criteria: Children between the ages of 10- and 12-years old; Presence of clinically-relevant internalizing symptoms (e.g., anxiety or depression) as defined by any of the following: T-score ≥ 65 on the Anxiety or Depression subscales of the CBCL; T-score ≥ 65 on any of the subscales of the RCADS; Currently receiving psychotherapy or prescribed psychotropic medication to treat identified psychological distress; presence of relevant somatic symptoms defined by a score of any one of the following: T-score ≥ 65 on the Somatic subscale of the Child Behavior Checklist (CBCL); Raw score > 10 on the parent- or child-rated CSI-24; Current medical intervention for somatic pain in the absence of an organic disease (e.g., medical treatment for migraines or irritable bowel syndrome) Exclusion Criteria: The presence of a physical handicap or injury that prevents participation or puts them at a high risk for further injury in the integrative intervention; A diagnosis of a pervasive developmental disorder (by history); a current eating disorder, including anorexia nervosa, bulimia, or binge eating disorder; active psychosis; A history of drug, alcohol or chemical abuse within 6-months prior to screening; Non-English speaking; Participation in a current structured yoga practice

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
The proposed 12-week intervention will integrate yoga-based skills with cognitive-behavioral principles. The development of this program was based on existing and empirically-validated cognitive-behavioral interventions for youth (i.e., Coping Cat and Cat Project; Kendall et al.) and therapeutic yoga interventions (e.g., Galantino et al., 2008 for review). The intervention will be broken down into four three-week modules, which address the following: Module 1: Introduction to group and awareness of body Module 2: Awareness of emotion and developing an understanding of the mind-body connection Module 3: Focus on cognitive process Module 4: Experiential practice and therapeutic discussions

Groupe II

Pas d'intervention
Participants in the waitlist condition will not receive any experimental intervention. They can continue any treatments as usual. The waitlist will be approximately 10-14 weeks in duration. At the end they will be offered the opportunity to participate in the intervention. If they elect to participate in the intervention, post-study data will also be collected from this group, approximately 13-weeks following the first group session.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Duke Child and Family Study Center

Durham, United StatesOuvrir Duke Child and Family Study Center dans Google Maps
Terminé1 Centres d'Étude