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- Ensaio Clínico NCT04020289
A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder
A Randomized Controlled Trial of a Psychoeducational Program"BalancingMySwing" for Patients With Bipolar Disorder
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: "BalancingMySwing"
Psychoeducational Program "BalancingMySwing" for bipolar disorder
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Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy
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Outro: treatment as usual (TAU)
Patients received treatment as usual
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Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Changes from Baseline Social Rhythm through Study Completion, at the 3rd and the 6th month after study completion
Prazo: 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.
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At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
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Changes from Baseline Illness Perception through Study Completion, at the 3rd and the 6th month after study completion
Prazo: 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
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Changes from Baseline Manic Symptom through Study Completion, at the 3rd and the 6th month after study completion
Prazo: 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.
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At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
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Changes from Baseline Depressive Symptom through Study Completion, at the 3rd and the 6th month after study completion
Prazo: 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.
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At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Esther C Lin, National Cheng Kung University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NCKU
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- ANALYTIC_CODE
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