- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02734212
Ending Self Stigma for PTSD (ESS-P)
Reducing Internalized Stigma Among Veterans With PTSD: A Pilot Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Stigma and fear of stigma are widespread among Veterans with PTSD and both have pernicious effects on Veterans' well-being and participation in mental health treatment. Internalized stigma is a harmful consequence of societal stigma, and has been associated with decreased hope, self-esteem, personal motivation, morale, self-regard, and persistence regarding illness management among individuals with a range of mental illnesses. Internalized stigma also has negative impacts on the recovery and well-being of Veterans with PTSD specifically, but no evidence-based interventions are currently available to assist Veterans with PTSD in combatting the impact of internalized stigma. Therefore, the purpose of this proposal is to develop and pilot-test an intervention to provide Veterans with PTSD the skills to cope effectively with stigma and to mitigate the internalization of stigmatizing beliefs and stereotypes. To that end, the investigators will modify Ending Self Stigma (ESS), an intervention composed of evidence-based strategies for combating internalized stigma for mental illness developed by the investigators' team, to specifically serve the needs of Veterans with PTSD.
This proposed project is composed of two phases. In Phase I, the investigators will produce an intervention and accompanying manual for the PTSD version of ESS (ESS-P), based upon the strategies and structure of the existing ESS intervention. To this end, the investigators will interview Veterans with a PTSD diagnosis to learn more about their experience with societal and internalized stigma associated with PTSD, plus other considerations and issues in addressing internalized stigma with such Veterans. Information gleaned in these qualitative interviews will form the basis of the investigators' adaption of the ESS intervention to specifically address the needs of Veterans with PTSD. In Phase II, the investigators will pilot-test ESS-P with Veterans who have PTSD, to evaluate the feasibility and acceptability of the intervention. In addition, the investigators will preliminarily estimate the effects of ESS-P through comparison to a control group receiving only an informational brochure on internalized stigma associated with PTSD. These feasibility, implementation and pilot outcome data will be used to further refine the intervention, towards the goal of conducting a future larger scale study of ESS-P within the VA system.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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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:
- a diagnosis of PTSD
- age between 18 and 70
- participation in mental health services at the VAMHCS
- sufficient clinical stability to participate
Exclusion Criteria:
a diagnosis of serious mental illness
- schizophrenia/schizoaffective disorder
- bipolar disorder
- major depression with psychotic features
- participation in the Phase I qualitative study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Ending Self-Stigma for PTSD
Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes.
Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving.
Each session is designed to focus on a specific strategy for addressing self-stigma.
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Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes.
Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving.
Each session is designed to focus on a specific strategy for addressing self-stigma.
Otros nombres:
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Otro: Enhanced Treatment as Usual
The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both.
Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
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The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both.
Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Internalized Stigma of Mental Illness Inventory (Internalized Stigma)
Periodo de tiempo: Basline and Post Treatment (~3 1/2 months)
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The Internalized Stigma of Mental Illness Inventory was used to measure of internalized or self-stigma.
A total score is calculated by taking an average of the responses on the items (range=1 to 4).
Higher total scores indicate greater internalized stigma.
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Basline and Post Treatment (~3 1/2 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
General Self-Efficacy
Periodo de tiempo: Baseline and Post Treatment (~3 1/2 months)
|
The General Self-Efficacy subscale of Sherer's Self-Efficacy Scale was used to measure participant's general beliefs or expectations about their abilities.
A total score is calculated by summing the responses on the items (range= 17-85).
Higher score indicate greater general self-efficacy.
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Baseline and Post Treatment (~3 1/2 months)
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Social Self-Efficacy
Periodo de tiempo: Baseline and Post Treatment (~3 1/2 months)
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The Social Self-Efficacy subscale of Sherer's Self-Efficacy Scale was used to measure participant's beliefs or expectations about their abilities with regards to social interactions/relationships.
A total score is calculated by summing the responses on the items (range= 5-30).
Higher score indicate greater social self-efficacy.
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Baseline and Post Treatment (~3 1/2 months)
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D1432-P
- 1I21RX001432-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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