- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05523453
Examinando los efectos de un enfoque terapéutico sobre los recuerdos positivos en la salud postraumática
Examen y refinamiento de un nuevo tratamiento para el trastorno de estrés postraumático: técnica de procesamiento de recuerdos positivos (PPMT)
El trastorno de estrés postraumático (TEPT) tiene consecuencias devastadoras para la salud. Las intervenciones de PTSD basadas en la evidencia abordan la carga sustancial del PTSD en la salud de las personas y las sociedades; sin embargo, varias personas que reciben estas intervenciones abandonan y no todas las personas experimentan una mejoría en los síntomas del PTSD. Además, estas intervenciones actuales de PTSD se dirigen principalmente a los recuerdos traumáticos. En particular, la creciente evidencia sugiere que los síntomas del PTSD también están relacionados con dificultades en la codificación y recuperación de recuerdos positivos.
Por lo tanto, el estudio propuesto examinará los efectos y los objetivos subyacentes de una nueva técnica de PTSD centrada en narrar y detallar recuerdos positivos: la técnica de procesamiento de recuerdos positivos (PPMT). Metodológicamente, 70 individuos serán asignados al azar a PPMT vs. Consejería de Apoyo (SC) para este estudio.
Los objetivos del estudio propuesto incluyen (1) examinar los efectos de la PPMT sobre la gravedad de los síntomas del TEPT y la desregulación de los sistemas de estrés (es decir, despertar la alfa amilasa salival [sAA] y el cortisol); (2) examinar los mecanismos subyacentes a los efectos de PPMT; y (3) refinación de PPMT. Se plantea la hipótesis de que el brazo de PPMT informará mayores disminuciones en la gravedad del TEPT y las proporciones de sAA/cortisol. Además, se plantea la hipótesis de que la mejora del afecto relacionado con la EMPP mediará la asociación entre el brazo del estudio (PPMT frente a SC) y los cambios en la gravedad del TEPT. Por último, se obtendrán comentarios de los participantes del estudio sobre la viabilidad, el formato y el contenido de PPMT para perfeccionar PPMT.
El estudio propuesto puede aportar evidencia preliminar sobre la importancia potencial de enfocarse en los recuerdos positivos en las intervenciones de PTSD.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Texas
-
Denton, Texas, Estados Unidos, 76203
- University of North Texas
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Descripción
Criterios de inclusión:
- 18-65 años
- Dispuesto/capaz de dar su consentimiento informado
- Mes anterior Diagnóstico de trastorno de estrés postraumático (TEPT) del DSM-5
- Conocimiento práctico del inglés.
Criterio de exclusión:
- Intención o intentos suicidas activos
- Psicosis activa
- Actualmente recibiendo terapia de salud mental (últimos 3 meses)
- Cambios de dosis en medicamentos psiquiátricos (últimos 3 meses)
- actualmente embarazada
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Técnica de Procesamiento de Memorias Positivas (PPMT)
Los participantes reciben 5 sesiones de 60 minutos de la Técnica de Procesamiento de Recuerdos Positivos (PPMT, por sus siglas en inglés) para el TEPT siguiendo los procedimientos de tratamiento descritos en el manual de terapia de PPMT.
|
PPMT consta de 5 sesiones enfocadas en identificar y procesar recuerdos positivos.
En las sesiones 1 a 5, los participantes narran los detalles de un recuerdo positivo y procesan el recuerdo positivo para obtener valores, afectos, fortalezas y pensamientos positivos.
|
|
Comparador activo: Consejería de apoyo (SC)
Los participantes reciben 5 sesiones de asesoramiento de apoyo (SC) de 60 minutos.
SC incluye una discusión del diario de seguimiento diario y la exploración de problemas y preocupaciones actuales.
|
SC es un tratamiento activo y no específico de 5 sesiones administrado semanalmente, que incluye una discusión del diario de seguimiento diario y la exploración de problemas y preocupaciones actuales.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Periodo de tiempo: Baseline
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
Baseline
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Periodo de tiempo: Week 1 post-baseline during therapy session
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
Week 1 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Periodo de tiempo: Week 2 post-baseline during therapy session
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
Week 2 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Periodo de tiempo: Week 3 post-baseline during therapy session
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
Week 3 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Periodo de tiempo: Week 4 post-baseline during therapy session
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
Week 4 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Periodo de tiempo: Week 5 post-baseline during therapy session
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
Week 5 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Periodo de tiempo: 1 week after the last therapy session, at week 6 post-baseline
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
1 week after the last therapy session, at week 6 post-baseline
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Periodo de tiempo: 3-months posttreatment completion, at week 18 post-baseline
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
3-months posttreatment completion, at week 18 post-baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Awakening Salivary Alpha Amylase to Cortisol Ratio
Periodo de tiempo: 3 times each day for 2 consecutive days prior to first therapy session
|
Via a passive drool procedure, participants provided 3 whole saliva samples each day for 2 consecutive days both prior to PPMT/SC: (1) immediately upon awakening, (2) 30 minutes post-awakening, and (3) 60 minutes post-awakening.
For each marker, for each day, area under the curve with respect to ground (AUCg) was calculated.
The two-day average AUCg of sAA was then divided by the two-day average AUCg of cortisol to create the ratio variable.
Higher sAA/cortisol ratio indicates greater stress system dysregulation and sympathetic nervous system dominance.
|
3 times each day for 2 consecutive days prior to first therapy session
|
|
Awakening Salivary Alpha Amylase to Cortisol Ratio
Periodo de tiempo: 3 times each day for 2 consecutive days after the last therapy session
|
Via a passive drool procedure, participants provided 3 whole saliva samples each day for 2 consecutive days one week following PPMT/SC: (1) immediately upon awakening, (2) 30 minutes post-awakening, and (3) 60 minutes post-awakening.
For each marker, for each day, area under the curve with respect to ground (AUCg) was calculated.
The two-day average AUCg of sAA was then divided by the two-day average AUCg of cortisol to create the ratio variable.
Higher sAA/cortisol ratio indicates greater stress system dysregulation and sympathetic nervous system dominance.
|
3 times each day for 2 consecutive days after the last therapy session
|
|
Positive and Negative Affect Schedule
Periodo de tiempo: Baseline
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Baseline
|
|
Positive and Negative Affect Schedule
Periodo de tiempo: Week 1 post-baseline during therapy session
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 1 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Periodo de tiempo: Week 2 post-baseline during therapy session
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 2 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Periodo de tiempo: Week 3 post-baseline during therapy session
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 3 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Periodo de tiempo: Week 4 post-baseline during therapy session
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 4 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Periodo de tiempo: Week 5 post-baseline during therapy session
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 5 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Periodo de tiempo: 1 week after the last therapy session, at week 6 post-baseline
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
1 week after the last therapy session, at week 6 post-baseline
|
|
Positive and Negative Affect Schedule
Periodo de tiempo: 3-months posttreatment completion, at week 18 post-baseline
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
3-months posttreatment completion, at week 18 post-baseline
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ateka Contractor, PHD, University of North Texas Health Science Center
Publicaciones y enlaces útiles
Publicaciones Generales
- Contractor AA, Blumenthal H, Rosenfield D, Shea MT, Taylor DJ, Fentem A, Vingren JL. Study protocol and rationale for a pilot randomized clinical trial comparing processing of positive memories technique with supportive counseling for PTSD. Contemp Clin Trials. 2024 Mar;138:107455. doi: 10.1016/j.cct.2024.107455. Epub 2024 Jan 20.
- Rodenbaugh MM, Almeida I, Solakoglu L, Jin L, Contractor AA. Client and therapist experiences with the Processing of Positive Memories Technique (PPMT) in a randomized controlled trial: insights for protocol refinement. Eur J Psychotraumatol. 2026 Dec;17(1):2692887. doi: 10.1080/20008066.2026.2692887. Epub 2026 Jul 29.
- Contractor AA, Rosenfield D, Almeida IM, Wang S, Taylor DJ, Weiss NH, Shea MT. Comparison of the processing of positive memories technique and supportive counseling for posttraumatic stress disorder: A randomized controlled trial. Behav Res Ther. 2026 Aug;203:105087. doi: 10.1016/j.brat.2026.105087. Epub 2026 May 19.
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 (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R15MH129773-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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. .