WtoHWindow to Hope-Evaluating a Psychological Treatment for Hopelessness Among Veterans With Traumatic Brain Injury
Window to Hope
+ Waitlist Control
Maladies du cerveau+5
+ Traumatismes crâniens
+ Maladies du système nerveux central
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 2012
Date à laquelle le premier participant a commencé l'étude.Prior to implementing the intervention, Dr. Simpson will work with VA study team members (e.g., Drs. Brenner, Matarazzo, Signoracci) to modify WtoH manual semantics and graphics to meet the needs of the U.S. Veteran population. Dr. Brenner has a long history of working within the Veterans Health Administration (VHA) and is a Diplomate in Rehabilitation Psychology. An expert committee (up to 15 participants) will also be convened for a meeting focused on the cross-cultural adaptation of WtoH. All efforts will be made to include experts in treating TBI and stakeholders (e.g., Veterans with or without TBI and/or family members/support persons) on the committee. Members of the research team will contact potential committee members by phone, email, mail or in person. Presentations may also be made to Veterans/family members/support persons receiving care, participating in patient advocacy activities, or providing peer support. Prior to reviewing the content, the expert committee will be provided background on the current state of knowledge about suicidality and hopelessness after TBI, available treatment options, and information regarding the underlying theoretical basis and key features of the WtoH program. The committee will then review the ten sessions to identify potential changes required to the therapeutic content, exercises, language and graphics to ensure that it is culturally appropriate for the VAMC context. Modifications will be made employing a consensus approach among the expert committee. The adapted program will then be trialed across four pilot groups. Once the pilot groups have been completed (see below) the expert committee will be reconvened for a final review of the program. Data collected on acceptability and feasibility will be presented to the committee and test therapists. Any necessary final modifications to assessment procedures and/or the intervention to ensure that the program is appropriate for the Veterans' condition will be made employing a consensus approach. The revised version of the manual will be used to conduct the RCT. Up to 90 Veterans will participate.
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.44 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 89 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
Critères
Inclusion Criteria for Pilot Groups: Age between 18 and 89 Determination of positive history of moderate/or severe TBI Ability to adequately respond to questions regarding the informed consent procedure Exclusion Criteria for Pilot Groups: History of alcohol abuse in the seven days prior to baseline assessment History of non-alcohol substance abuse within the last 30 days prior to baseline assessment Same-day drug or alcohol abuse during treatment History of mild TBI only Inability to travel to the Denver VA for daily or weekly therapy sessions Inclusion Criteria for RCT: Age between 18 and 65 Determination of positive history of moderate/or severe TBI Beck Hopelessness Scale score of 9 or greater Ability to adequately respond to questions regarding the informed consent procedure Exclusion Criteria for RCT: Diagnosis of neurological condition(s) History of alcohol abuse in the seven days prior to baseline assessment History of non-alcohol substance abuse within the last 30 days prior to baseline assessment Same-day drug or alcohol abuse during treatment History of mild TBI only Inability to travel to the Denver VA for weekly therapy sessions
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
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
VA Eastern Colorado Health Care System
Aurora, United StatesOuvrir VA Eastern Colorado Health Care System dans Google Maps