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Understanding Treatment Adherence Among Individuals With Bipolar Disorder

29 de julio de 2019 actualizado por: Martha Sajatovic, MD, Case Western Reserve University

Determinants and Manifestation of Illness Behavior in Promoting Treatment Adherence Among Individuals With Bipolar Depression

This study will examine how various factors, such as psychiatric symptoms, gender, social support, substance use, and attitudes toward medication, affect treatment adherence in individuals with bipolar disorder.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Bipolar Disorder (BPD), also known as manic-depressive illness, is a disorder that causes frequent shifts in an individual's mood, energy, and ability to function. An individual with BPD may go through periods of mania, which are characterized by increased energy, irritability, and an excessively "high" euphoric mood. The manic periods are followed by periods of depression, which are characterized by decreased energy, feelings of hopelessness, and anxiety. BPD is a persistent and severe mental illness with a high suicide rate; it must be strictly managed through medication and therapy. Many BPD medications have been developed recently; however, there are still many individuals who do not respond well to medication treatment. Research has shown that the way individuals experience illness has an effect on their response to medication. The purpose of this study is to gain insight into how individuals with BPD perceive and respond to medication treatment. Factors such as gender, degree of social support, drug and alcohol usage, and attitudes towards medication will be evaluated to understand how they affect medication and treatment adherence.

This 6-month study will consist of 3 interviews. Each interview will last approximately 2 and ½ hours and will include numerous standardized psychological questionnaires. The questionnaires will assess participants' attitudes toward BPD treatment; psychiatric illness severity, including symptoms of mania and depression; level of addiction to alcohol and drugs; availability of social support resources; and medication adherence.

Tipo de estudio

De observación

Inscripción (Actual)

140

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

  • Estados Unidos
    • Ohio
      • Beachwood, Ohio, Estados Unidos, 44122
        • Northeast Ohio Health Services

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Individuals with bipolar disorder receiving treatment at a Community Mental Health Clinic in Northeast Ohio.

Descripción

Inclusion Criteria:

  • Clinical diagnosis of bipolar disorder type I for at least two years prior to study entry
  • Has experienced an index depressive episode
  • Received treatment with medication to stabilize mood for at least 6 months prior to study entry
  • Able to participate in psychiatric interviews
  • Lives in the Northeast Ohio area and is a patient at either Northeast Ohio Health Services or The Mood Disorders Clinic at University Hospitals of Cleveland

Exclusion Criteria:

  • Unable/unwilling to participate in psychiatric interviews

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Attitudes toward Mood Stabilizers Questionnaire (AMSQ)
Periodo de tiempo: Change from Baseline to 6 month visit
The AMSQ is a 19-item scale which is a modification of the Lithium Attitudes Questionnaire (LAQ) that evaluates an individual's attitude toward mood-stabilizing medication. The questions are in a yes/no format. The AMSQ has 7 subscales that represent key attitudinal domains with respect to adherence, as follows: 1. opposition to prophylaxis, 2. denial of therapeutic effectiveness, 3. fear of adverse effects, 4. difficulty with medication routines, 5. denial of illness severity, 6. negative attitude toward drugs in general, and 7. lack of information about mood stabilizers. Total scores range from 0 to 19. Higher scores on the total and each subscale represent more negative attitudes toward mood stabilizers.
Change from Baseline to 6 month visit
Brief Psychiatric Rating Scale (BPRS)
Periodo de tiempo: Change from Baseline to 6 month visit
The BPRS measures levels of mania. There are 24 items, scored on a 7-point scale ranging from 0 to 6. Total scores range from 0 to 42, with higher scores indicating higher levels of mania.
Change from Baseline to 6 month visit
Addiction Severity Index (ASI)
Periodo de tiempo: Change from Baseline to 6 month visit

A portion of the standardized instrument measuring level of addiction to alcohol and drugs. Items 1-14 of the Alcohol/Drug index were used. The ASI evaluated both lifetime and past-30 day use of a wide variety of commonly abused substances. Each question is divided by its maximum answer value and by the total number of questions in the composite. These individual results are then summed.

The six questions (A-F) that make up the alcohol composite score is determined by:

A/180 + B/180 + C/180 + D/24 + E/24 + log F/44.

The 13 questions (A-M) that make up the drug composite score is determined by:

A/390 + B/390 + C/390 + D/390 + E/390 + F/390 + G/390 + H/390 + I/390 + J/390 + K/390 + L/52 + M/52.
Change from Baseline to 6 month visit
Interpersonal Suppose Evaluation List (ISEL)
Periodo de tiempo: Change from Baseline to 6 month visit
The ISEL is a 40-item self-report questionnaire that was developed to assess availability of social support resources. A total index is composed of four subscales: tangible assistance (material aid), appraisal (availability of someone to talk to about life's problems), self-esteem (positive appraisal of self from others and positive comparison when comparing one's self with others) and belonging (people with whom one can do things). Response for each item is coded on a 4-point Likert scale ranging from definitely false to definitely true. Total scores range from 0 to 120, with higher scores indicating a higher availability of perceived social support.
Change from Baseline to 6 month visit
Tablets Routine Questionnaire (TRQ)
Periodo de tiempo: Change from Baseline to 6 month visit
The TRQ evaluates adherence to medications via a brief self-report instrument that has been validated in populations with bipolar disorder medication adherence. The TRQ identifies nonadherent individuals, defined as those who miss 30% or more of their medication in the last week or month. Total scores are represented as a percentage and range from 0 to 100, with higher scores indicating a greater level of nonadherence (higher scores indicate worse adherence to medications).
Change from Baseline to 6 month visit
Hamilton Rating Scale for Depression (HAM-D)
Periodo de tiempo: Change from Baseline to 6 month visit
The HAM-D measures form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Total scores range from 0-52, with higher scores indicating worse depression. The categories are as follows: 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score is 52.
Change from Baseline to 6 month visit

Colaboradores e Investigadores

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

Patrocinador

Case Western Reserve University

Colaboradores

National Institute of Mental Health (NIMH)

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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

1 de marzo de 2004

Finalización primaria (Actual)

1 de marzo de 2007

Finalización del estudio (Actual)

1 de agosto de 2007

Fechas de registro del estudio

Enviado por primera vez

13 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

13 de septiembre de 2005

Publicado por primera vez (Estimar)

16 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

31 de julio de 2019

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

29 de julio de 2019

Última verificación

1 de julio de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • K23MH065599-01 (Subvención/contrato del NIH de EE. UU.)
  • DAHBR 9K-TA

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. .

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