Written Exposure Therapy for Childbirth-related Post-Traumatic Stress (SCRIBE)
Written Exposure Therapy (WET) for the Treatment of Childbirth-related Post-Traumatic Stress: A Pilot Study
In this research study, the investigators hope to determine whether Written Exposure Therapy is a feasible intervention for postpartum women experiencing trauma symptoms related to childbirth to complete. Written Exposure Therapy involves five structured psychotherapy sessions that can be conducted over telehealth.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Childbirth-related posttraumatic stress disorder (CB-PTSD) affects approximately one in twenty women after any given childbirth. Postpartum women are faced with unique barriers to accessing and engaging in evidence-based treatment for PTSD. Aside from avoidance, limited time and financial and logistical barriers regarding childcare can make it difficult to engage in long-term therapy or travel to frequent in-person visits. Therefore, postpartum individuals may find a brief telehealth-based intervention, Written Exposure Therapy, to be highly appealing and well-aligned with the demands of postpartum parenting.
Written exposure therapy (WET) is a highly protocolized evidence-based brief psychotherapeutic intervention for the treatment of PTSD that may be promising for women with CB-PTSD. WET consists of 5 treatment sessions. In the first, patients receive brief psychoeducation about PTSD and avoidance as a maladaptive behavior that maintains PTSD symptoms. In each of the five sessions, the patient writes about the same single traumatic event with a focus on feelings and cognitions during the event and how the event has affected their lives. Written exposure therapy can be conducted via telehealth, does not require between-session assignments for patients, is non-inferior to cognitive processing therapy and prolonged exposure therapy, and involves only four total hours of treatment, thus decreasing treatment time by 50-80% compared to other evidence-based psychotherapies for PTSD. This study aims to assess whether postpartum individuals would find such an intervention feasible and be able to maintain engagement to complete the protocol.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Amanda Koire, MD, PhD
- Número de teléfono: (617) 525-3707
- Correo electrónico: akoire@bwh.harvard.edu
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Reclutamiento
- Brigham and Women's Hospital
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Contacto:
- Amanda Koire, MD, PhD
- Número de teléfono: 617-525-3707
- Correo electrónico: mgbscribe@mgb.org
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Birthing individuals
- 18 years of age or older
- Living in Massachusetts
- Can read, write, and speak English
- Identified a traumatic event exposure related to their childbirth experience
- Are between one month to two years postpartum
- Have a probable CB-PTSD diagnosis based on a PCL-5 score ≥ 28.
Exclusion Criteria:
- Current engagement in another form of trauma-focused psychotherapy
- No or little memory of the traumatic event
- Safety concerns including active suicidality, active psychosis, and heavy substance use with inability to cease substance use for at least 2 hours before and after each session.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Terapia de exposición escrita
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Written exposure therapy (WET) is a highly protocolized evidence-based brief psychotherapeutic intervention for the treatment of post-traumatic stress disorder (PTSD). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Feasibility (retention rate)
Periodo de tiempo: From date of the first WET session until the date of the fifth WET session, withdrawal from the study, or determination of loss to follow-up, whichever occurs first (estimated average assessment period: 6 weeks).
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Feasibility will be measured retention rate across five Written Exposure Therapy (WET) sessions. Retention rate is defined as the number of participants who complete all five WET sessions divided by the total number of participants who engaged in at least one WET session. A higher value indicates higher retention. We expect at least 75% of enrolled participants will complete treatment once initiated. |
From date of the first WET session until the date of the fifth WET session, withdrawal from the study, or determination of loss to follow-up, whichever occurs first (estimated average assessment period: 6 weeks).
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Feasibility (Engagement rate)
Periodo de tiempo: From the date of enrollment until the date of the first WET session, withdrawal from the study, or determination of loss to follow-up, whichever occurs first (estimated average assessment period: 4 weeks).
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Engagement will be measured as the number of participants who engaged in at least one Written Exposure Therapy session divided by the number of women who enrolled in the study. A higher value indicates higher engagement. We expect at least 75% of enrolled participants will engage in treatment. |
From the date of enrollment until the date of the first WET session, withdrawal from the study, or determination of loss to follow-up, whichever occurs first (estimated average assessment period: 4 weeks).
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Acceptability (Credibility)
Periodo de tiempo: Baseline
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Credibility will be measured using the pre-intervention credibility/expectancy questionnaire (CEQ) which assesses patient perception of whether treatment seems logical and useful. Credibility is scored as the sum of the first three scale items on the credibility/expectancy questionnaire. Scores range from 3-27, with higher scores indicating greater credibility. |
Baseline
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Acceptability (Satisfaction)
Periodo de tiempo: Study exit survey approximately 4 weeks after final WET session.
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Satisfaction will be measured as total score on the post-intervention Client Satisfaction Questionnaire-8 (CSQ-8) survey. Scores range from 8-32, with higher numbers indicating greater satisfaction. |
Study exit survey approximately 4 weeks after final WET session.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in PTSD Symptoms Assessed by the PTSD Checklist for DSM-5
Periodo de tiempo: From enrollment to study exit survey approximately 4 weeks after the final written exposure therapy session.
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The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Scores range from 0 to 80 and a score at or above 28 is indicative of probable CB-PTSD. A 9 point change represents reliable change. |
From enrollment to study exit survey approximately 4 weeks after the final written exposure therapy session.
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Changes in EPDS Symptoms Assessed by the Edinburgh Postnatal Depression Scale
Periodo de tiempo: From enrollment to study exit survey approximately 4 weeks after the final written exposure therapy session.
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The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire used during pregnancy and postpartum to screen for perinatal and postpartum depression. Scores range from 0-30 and a score at or above 10 is indicative of a positive screen for perinatal depression. A 4 point change indicates reliable change. |
From enrollment to study exit survey approximately 4 weeks after the final written exposure therapy session.
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Changes in PSS Symptoms Assessed by the Perceived Stress Scale
Periodo de tiempo: From enrollment to study exit survey approximately 4 weeks after the final written exposure therapy session.
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The Perceived Stress Scale (PSS) is a 10-item self-report questionnaire designed to assess perceptions of recent stress. Scores range from 0 to 40, with higher scores indicating higher perceived stress. A 6 point change indicates reliable change. |
From enrollment to study exit survey approximately 4 weeks after the final written exposure therapy session.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- 2025P000531
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data will not be shared due to privacy and confidentiality concerns. Aggregate study results will be made publicly available on ClinicalTrials.gov and through publications.
Información sobre medicamentos y dispositivos, documentos del estudio
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