- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03820297
Anti-stigma Intervention for Chinese American Older Adults
Effects Of Anti-Stigma Intervention For Chinese American Older Adults With Mood And Anxiety Disorders
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10016
- New York University School of Medicine
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Self-reported Chinese heritage;
- 55 years or older
- Mandarin and/or Cantonese speaking and ability to read and/or comprehend spoken Chinese language.
- Currently receiving treatment from a mental health provider at Gouverneur Medical Center Asian Bicultural Clinic (GMC ABC) and willing to continue mental health care through the study.
- Willing to provide release for communication between primary mental health care provider and study staff throughout the study.
- Documented by mental health provider after consent for release of information as having mood and anxiety disorder diagnosis in the past year;
- A willingness to participate in the ASGI with stated availability;
- Able and willing to provide informed consent.
Exclusion Criteria:
- Lifetime psychosis, neurocognitive, or significant neurological disorders;
- Current manic episode;
- Past 6 months of alcohol/substance use disorder;
- Serious safety concerns of suicide or homicide.
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 |
---|---|
Otro: Anti-Stigma Group
Complete a 10 weekly anti-stigma group intervention (ASGI) in addition to several self-report internalized stigma and psychiatric measures.
|
10-session intervention will occur weekly for 45 minutes per session: psychoeducation about mood and anxiety disorders, focusing on identification of risk factors and biological theory to counter stigma; psychoeducation regarding 'therapeutic modules' (psychotropics and psychotherapy) to treat depression, with an emphasis on the importance of psychiatric treatment adherence, providing behavioral strategies for anticipated and experienced forms of mental illness related work, social, or family discrimination
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Self stigma of mental illness scale
Periodo de tiempo: 23 weeks
|
This 40-item self-report scale assesses the extent of patient self-stigma. Items are rated on a 9-point Likert-type scale (1= Strongly Disagree; 9= Strongly Agree). Total score from 1 to 9 (average score) Higher score means worse outcome |
23 weeks
|
Recovery assessment scale
Periodo de tiempo: 23 weeks
|
Empowerment will be assessed using the 15-item scale from the Recovery Assessment Scale. This scale measures domains of recovery including 1) personal confidence and hope 2) willingness to ask for help 3) goal and success orientation 4) reliance on others 5) symptom coping. Patients are asked to describe themselves using a 5-point agreement scale (1= strongly disagree, 5= strongly agree) regarding their recovery. Total score from15 to 75 (summed score) Higher score means better outcome |
23 weeks
|
Self-protective Withdrawal and Secrecy scale
Periodo de tiempo: 23 weeks
|
Changes in use of self-protective withdrawal and secrecy as a strategy for coping with public stigma will be evaluated using two scales to assess patients' responses to their stigmatized status.
Total score: 6 to 42 (average score). For the overall scale, summed score will be used. Higher score means better outcome |
23 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in social support
Periodo de tiempo: 23 weeks
|
The subjective support and social interaction subscales from the Abbreviated Duke Social Support Scale (ADSSS) will be used to measure changes in social support. It is an 11-item Likert-type scalewhich has been shown to correlate well with mental and physical health outcomes.
Total score: 7 to 21 (summed score) For the overall scale, total score from 11 to 33 (summed score of two subscales). A higher score means better outcome |
23 weeks
|
Changes in patient depressive symptoms measured by Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: 23 weeks
|
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item interview assessing depressive symptoms which is a reliable and valid measure of depression severity (0=not at all, 1=several days, 2=more than half the days, 3=nearly everyday). Total score: 27 (summed score). A higher score means worse outcome |
23 weeks
|
Changes in patient anxiety symptoms associated with stigma reduction
Periodo de tiempo: 23 weeks
|
The Generalized Anxiety Disorder 7-item Scale (GAD-7) is a 7-item interview assessing anxiety symptoms (0=not at all, 1=several days, 2=more than half the days, 3=nearly everyday). Total score: 21 (summed score will be used). A higher score means worse outcome |
23 weeks
|
Colaboradores e Investigadores
Patrocinador
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
- 18-01236
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.
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 10 sessions of ASGI
-
Zagazig UniversityTerminadoVacuna contra la hepatitis B intralesional versus intramuscular para las verrugas comunes múltiplesEgipto