Integrative Exercise for Post-Deployment Stress
Despite the considerable efforts of the DoD and VA to improve awareness of mental health problems and access to care, many returning veterans still report substantial barriers to seeking traditional mental health care. Research suggests that a significant barrier to pursuing treatment is the perception of stigma (Hoge at al., 2004). The primary objective of this 12-week pilot, randomized controlled trial (RCT) is to obtain pilot data on the utilization and efficacy of a standardized, integrative exercise protocol (aerobic exercise and mindful breath training) in addressing global post-traumatic stress disorder (PTSD) symptoms, sleep disturbances, and non-sleep PTSD symptoms in veterans with PTSD. Specifically, this study will examine whether a 12-week course of Integrative Exercise therapy, a treatment lacking stigma, 1) produces significant pre-post improvements in PTSD symptoms and sleep disturbances (compared to a Monitor Only Waitlist condition) 2) improves other clinical outcomes including mood, alcohol and non-alcohol substance use, psychological distress, mindfulness, and overall quality of life (compared to a Monitor Only Waitlist condition) and 3) whether such treatment is feasible and acceptable.
A secondary aim of this study is to evaluate possible mechanisms underlying these effects such as chemicals in the blood related to stress, changes in brain imaging markers, aerobic capacity, and improved sleep.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
San Francisco, California, Estados Unidos, 94121
- Stress and Health Research Program, University of California San Francisco
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Between the ages of 18-65 and must be physically able to participate in an exercise program
- Participants will meet criteria for either current, full syndromal PTSD of at least 3 months duration, as indexed by the Clinician Administered PTSD Scale (CAPS) diagnostic criteria or partial PTSD defined by meeting the required number of symptoms in the B symptom cluster as well as the required number of symptoms in either the C or D symptom clusters.
Exclusion Criteria:
- Lifetime history of any psychiatric disorder with psychotic features, bipolar disorder, or mania or meet criteria for drug or alcohol dependence within the past year as assessed by the Structured Clinical Interview for DSM-IV-TR.
- Prominent suicidal or homicidal ideation
- Currently exposed to recurrent trauma or have been exposed to a traumatic event within the past 3 months
- Pregnant, have a clinically significant neurologic disorder, systemic illness affecting CNS function, history of seizure disorder, asthma, and/or physical disabilities making it impossible to use exercise equipment will be excluded
- Myocardial infarction (MI) in the past 6 months
- Moderate to severe Traumatic Brain Injury (any history of head trauma associated with the onset of persistent cognitive complaints, neurological symptoms, or loss of consciousness > 5 minutes)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Integrative Exercise
Subjects will exercise for 12 weeks (3 times weekly, with each total workout being approximately 60 minutes in length).
The exercise protocol will incorporate elements of mindfulness, cardiovascular strengthening, and controlled breathing.
|
|
|
Comparador activo: Monitor Only Waitlist
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Clinician Administered PTSD Scale (CAPS) score comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only
Periodo de tiempo: 12 weeks
|
12 weeks
|
|
Self-reported sleep quality comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only
Periodo de tiempo: 12 weeks
|
12 weeks
|
|
Hippocampal subfield volume comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only
Periodo de tiempo: 12 weeks
|
12 weeks
|
Colaboradores e Investigadores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 12-09594
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Síntomas del TEPT
-
COMPASS PathwaysAún no reclutandoTEPT | PTSD, trastorno de estrés postraumático | Síntomas del TEPT | PTSD - Trastorno de Estrés Postraumático
-
Modum BadInscripción por invitaciónTEPT | PTSD y síntomas relacionados con el traumaNoruega
-
VA Office of Research and DevelopmentTerminadoComportamientos de crianza y síntomas de PTSDEstados Unidos
-
University Hospital, ToursFondation Matmut Paul BennetotAún no reclutandoPTSD - Trastorno de Estrés Postraumático
-
White River Junction Veterans Affairs Medical CenterReclutamientoPTSD - Trastorno de Estrés PostraumáticoEstados Unidos
-
NeuroBrave ltd.ReclutamientoPTSD - Trastorno de Estrés PostraumáticoIsrael
-
Almaviva SanteReclutamientoPTSD - Trastorno de Estrés PostraumáticoFrancia
-
Medical Corps, Israel Defense ForceReclutamientoPTSD - Trastorno de Estrés PostraumáticoIsrael
-
Cognitive FXAún no reclutandoPTSD - Trastorno de Estrés PostraumáticoEstados Unidos
-
Reinier van ArkelTerminadoPTSD - Trastorno de Estrés PostraumáticoPaíses Bajos