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Anti-stigma Intervention for Chinese American Older Adults

19 de mayo de 2020 actualizado por: NYU Langone Health

Effects Of Anti-Stigma Intervention For Chinese American Older Adults With Mood And Anxiety Disorders

Approximately 50 participants will be enrolled and screened to achieve 45 eligible patients with mood/anxiety disorders to complete a 10 weekly anti-stigma group intervention (ASGI) in addition to several self-report internalized stigma and psychiatric measures.This study will examine changes in internalized stigma and psychiatric symptoms pre- and post-ASGI with 3 months post-intervention follow-up.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

16

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New York
      • New York, New York, Estados Unidos, 10016
        • New York University School of Medicine

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

55 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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.

  1. Secrecy subscale: a 5-item Likert-type scale (1=strongly agree, 6=strongly disagree) assessing use of concealment of mental illness.

    Total score: 5 to 30 (summed score)

  2. Withdrawal subscale consists of 7 items (1=strongly agree, 6=strongly disagree) assessing "limiting social interaction to those who know about and tend to accept one's stigmatized condition".

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.

  1. Social interaction sub-scale: patients are asked 4 items to describe their telephone and face-to-face interaction patterns during the past week (1=none, 2=1-2 people, 3=more than 2 people).

    Total score: 4 to 12 (summed score ).

  2. Satisfaction with social support sub-scale: they are asked to respond to 7 questions such as "Does it seem that your family and friends understand you most of the time, some of the time, or hardly ever?" (1=hardly ever, 2=some of the time, 3=most of the time).

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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

19 de agosto de 2019

Finalización primaria (Actual)

13 de marzo de 2020

Finalización del estudio (Actual)

13 de marzo de 2020

Fechas de registro del estudio

Enviado por primera vez

25 de enero de 2019

Primero enviado que cumplió con los criterios de control de calidad

25 de enero de 2019

Publicado por primera vez (Actual)

29 de enero de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de mayo de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

19 de mayo de 2020

Última verificación

1 de mayo de 2020

Más información

Términos relacionados con este estudio

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.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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

3
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