COPEIncentivizing Adherence to Prolonged Exposure With Substance Users
Prolonged Exposure Therapy
+ Voucher-Based Reinforcement
+ Prolonged Exposure Therapy
Trastornos Relacionados con el Estrés y el Trauma
+ Trastornos Mentales
+ Trastornos de Estrés Postraumático
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de septiembre de 2012
Fecha en la que se inscribió al primer participante.The aim of this research is to assess whether Contingency Management is effective in improving treatment adherence in substance use disordered (SUD) patients with comorbid PTSD. Although Prolonged Exposure therapy (PE) is the gold standard treatment for PTSD, the few studies of this treatment in substance users have shown poor adherence. Contingency Management is a well-established approach that could be used to enhance adherence to PE. From a consented sample of 125 opioid-dependent and methadone-treated patients at Addiction Treatment Services, an intent-to-treat sample of 62 patients with co-occurring current PTSD will be offered PE. Half of the 62 participants will be randomly assigned to a Prolonged Exposure with Contingency Management (PE+CM) condition that provides monetary-based incentives for attending the PE therapy sessions. The comparison condition will be assigned to a Prolonged Exposure (PE) condition without the attendance incentives intervention. The PE sessions will be scheduled once per week for 12 weeks, with a 12-week follow-up. Groups will be compared primarily on adherence to the PE schedule, improvement in PTSD symptoms, and rates of drug use (urine specimens, self-reported use). The study's three primary aims are to 1) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to increase adherence in SUD patients in a methadone treatment program; 2) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to reduce PTSD symptoms in SUD patients; and 3) Evaluate the effect of PE for PTSD on rates of drug use in SUD patients.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 126 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 100 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria for Phase I (evaluation): positive screen for PTSD, as determined by score on the MPSS-R methadone maintenance for at least 4 weeks (to help ensure initial stabilization on methadone) at least 18 years of age Inclusion criteria for Phase 2 (treatment): confirmation of current PTSD based on the Clinician-Administered PTSD Scale no psychiatric contraindications to PE (e.g., current suicidal/homicidal intent) clear memory for the traumatic event (e.g., flashbacks or re-experiencing the event) interest in receiving PE agree to sign release of information for any current psychiatric treatment providers outside of ATS agree to delay taking daily methadone dose on exposure therapy days until after session no history of prior exposure-based therapy for PTSD agree to audiotaping of therapy sessions Exclusion Criteria: pregnancy acute medical problem that requires immediate and intense medical management (e.g., AIDS defining illness; active tuberculosis) presence of a formal thought disorder, delusions, hallucinations, or imminent risk of harm to self or others
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Addiction Treatment Services
Baltimore, United StatesAbrir Addiction Treatment Services en Google Maps