A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder
16 de julio de 2019 actualizado por: Esther Ching-Lan Lin, National Cheng Kung University
A Randomized Controlled Trial of a Psychoeducational Program"BalancingMySwing" for Patients With Bipolar Disorder
The psychoeducation BalancingMySwing (BMS) program has been developed manually and its feasibility has been tested in our previous study.
This 3-year research project aimed to further examine the immediate and lasted effects of BMS program for BD, and to assess its knowledge dissemination and the transferability of its evidence-based practice across multiple sites.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The psychoeducation BalancingMySwing (BMS) program has been developed manually and its feasibility has been tested in our previous study. This 3-year research project aimed to further examine the immediate and lasted effects of BMS program for bipolar disorders (BD), and to assess its knowledge dissemination and the transferability of its evidence-based practice across multiple sites.
During the first 2 years, a randomized controlled trial was conducted. Patients diagnosed with BD were recruited and 104 patients were randomly assigned to treatment as usual (TAU) or to 8 BMS sessions. A battery of three outcome indicators-social rhythm, illness perception, and symptom severity-were used to examine the effects of the two groups at baseline, after intervention, and every 3 months until half year. In addition, a pre- and post-test quasi-experimental study combined with qualitative design was used to assess the translational feasibility of BMS and to explore related barriers and facilitators of implementing BMS in clinical settings in the third year. Nurses from 4 Hospitals received the BMS training, and patients with BD received the BMS translated in practice were recruited.
Tipo de estudio
Intervencionista
Inscripción (Actual)
120
Fase
- No aplica
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
20 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Had a DSM-IV(Diagnostic and Statistical Manual of Mental Disorders-IV) diagnosis of BP-I or II confirmed through the interviews using the Chinese version of the Modified Schedule of Affective Disorder and Schizophrenia-Lifetime.
- Able to speak and read Taiwanese or Taiwanese Mandarin Chinese
- Had signed a written consent form
- Agreed to accept the following medication therapy during the study: a mood stabilizer (valproic acid or lithium salts), an antidepressant, second generation antipsychotics, anxiolytics (lorazepam [< 8 mg/day]), and medicine to counteract side effects: extrapyramidal symptoms, tachycardia, and involuntary movement of smooth muscles in the gastrointestinal tract, urinary tract, lungs, etc.
Exclusion Criteria:
- Required immediate hospitalization
- Had any comorbidity with substance abuse or were current alcohol or drug abusers, or had been in the previous year
- Had been diagnosed with an organic psychosis, a neurodegenerative disease, a personality disorder, or impaired cognitive abilities
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: "BalancingMySwing"
Psychoeducational Program "BalancingMySwing" for bipolar disorder
|
Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy
|
|
Otro: treatment as usual (TAU)
Patients received treatment as usual
|
Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes from Baseline Social Rhythm through Study Completion, at the 3rd and the 6th month after study completion
Periodo de tiempo: At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
|
Social Rhythm Metric-5 items (SRM-5)-- The total scores range from 0 to 5; the higher the score the more regularly the activities occur.
|
At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
|
|
Changes from Baseline Illness Perception through Study Completion, at the 3rd and the 6th month after study completion
Periodo de tiempo: At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
|
Illness Perception Questionnaire-Revised (IPQ-R) has 3 subscales.
The first subscale (identity) determines whether patients attribute specific symptoms to BD (total score: range = 0-10).
The second subscale assesses 25 items of illness perceptions.
The third subscale assessed the causes of BD.
The second and third subscales are rated on a 5-point Likert scale (range: 1~5).
A higher score on each item indicates a stronger belief in that illness perception.
|
At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
|
|
Changes from Baseline Manic Symptom through Study Completion, at the 3rd and the 6th month after study completion
Periodo de tiempo: At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
|
Young Mania Rating Scale (YMRS)--The total score of the 11-item YMRS is the summation of the 2 subscales (range: 0-60), and could be divided into four levels: 0 to 12 means remission, 13 to 19 means minimal severe, > 20 as diagnosed with mania based on DSM-IV(Diagnostic and Statistical Manual of Mental Disorders, IV) criteria, and over 25 showed obvious symptoms.
|
At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
|
|
Changes from Baseline Depressive Symptom through Study Completion, at the 3rd and the 6th month after study completion
Periodo de tiempo: At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
|
Hamilton Depression Rating Scale (HDRS)--The total score of the 17-item HDRS is the summation of the 2 subscales(ranged: 0- 52), and could be divided into four levels: 0-7 means remission, 8-13 means mild severe, 14-22 means moderate severe, and > 23 means very severe.
|
At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Esther C Lin, National Cheng Kung University
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)
1 de agosto de 2015
Finalización primaria (Actual)
31 de julio de 2018
Finalización del estudio (Actual)
31 de diciembre de 2018
Fechas de registro del estudio
Enviado por primera vez
8 de julio de 2019
Primero enviado que cumplió con los criterios de control de calidad
11 de julio de 2019
Publicado por primera vez (Actual)
16 de julio de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de julio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
16 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
- NCKU
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
We plan to use only for data analysis and publication without any recognized individual identification.
Marco de tiempo para compartir IPD
Data analysis and publication will have occur at the end of the study, and continue after 7 months of the summary data are published.
Criterios de acceso compartido de IPD
Only the research members in out research team can access individual participant data (IPD) and any additional supporting information and only for statistic data analysis and publication under the PI supervision.
The PI will review all information shared to follow the research purpose.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
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. .