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Understanding Treatment Adherence Among Individuals With Rapid Cycling Bipolar Disorder

4 de fevereiro de 2019 atualizado por: Martha Sajatovic, MD, Case Western Reserve University

Rapid Cycling Bipolar Disorder (RCBPD), Subjective Illness Experience and Gender

This study will examine how various factors, such as psychiatric symptoms, gender, quality of life, and attitudes toward medication, affect treatment adherence in individuals with rapid cycling bipolar disorder.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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. Rapid cycling bipolar disorder (RCBPD) is a type of BPD in which the individual experiences four or more episodes of mania and depression per year. The rapid shift between the manic and depressive episodes makes it imperative that individuals with RCBPD strictly manage their illness with medication. 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 RCBPD 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 study will consist of 1 visit, which will last approximately 2 and ½ hours and will include an anthropological interview and numerous standardized psychological questionnaires. The interview and questionnaires will assess participants' attitudes toward BPD treatment; psychiatric illness severity, including symptoms of mania and depression; expectations regarding recovery, stigma, and quality of life; and medication adherence.

Tipo de estudo

Observacional

Inscrição (Real)

40

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Ohio
      • Beachwood, Ohio, Estados Unidos, 44122
        • Northeast Ohio Health Services
      • Cleveland, Ohio, Estados Unidos, 44106
        • University Hospitals of Cleveland

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

The population includes 20 individuals receiving treatment at an academic medical center and 20 individuals seeking treatment at a community mental health clinic.

Descrição

Inclusion Criteria:

  • Clinical diagnosis of rapid cycling variant of bipolar disorder type I; diagnosed 2 to 20 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
  • 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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Qualitative Interview
Participants with rapid cycling bipolar disorder (RCBPD)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The Subjective Experience of Medication Interview (SEMI)
Prazo: Baseline
The Subjective Experience of Medication Interview (SEMI) is a qualitative, semi-structured assessment of subjective experience of mental illness, which requires approximately 60-120 minutes to administer. Illness experience domains assessed include illness attitudes, attributions and behaviors, social relations, treatment history and medication experience, self-medication, quality of life, stigma, culture/ethnicity, and health care logistics. The SEMI has been modified for use in populations with Bipolar Disorder.
Baseline

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Hamilton Depression Rating Scale (HAMD)
Prazo: Baseline
A rater administered rating to scale to measure symptoms of depression, and is the most commonly utilized rating scale to assess depressive symptoms in bipolar depression clinical studies.
Baseline
Clinical Global Impression (CGI)
Prazo: Baseline
Global illness severity is measured with the Clinical Global Impressions (CGI), a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.66-0.41.
Baseline
Insight and Treatment Attitudes Questionnaire (ITAQ)
Prazo: Baseline
An 11-item rating scale to evaluate patient recognition of illness and need for treatment in psychiatric illness. Each ITAQ item is scored on a 0 to 2 scale (0 = no insight, 2 = good insight), and the scale has high interrater reliability (r=0.82, p<.001) (McEvoy 1981). Construct validity, checked by correlating scores with an open interview is also good (r=.85, p<.001).
Baseline
Illness Behavior Questionnaire (IBQ)
Prazo: Baseline
A 62-item instrument designed to measure a respondent's attitudes, ideas, affects and attributions in relation to illness. The IBQ is a self-reported scale, in which the respondent answers "yes" or "no" to each question regarding illness experience and subjective response. There are seven major subscales derived through factor analysis. The IBQ has very good stability, with one-to-twelve week test-retest correlations ranging from .67-.85 for the subscales. It has good face and content validity.
Baseline
Attitude Towards Mood Stabilizers Questionnaire (AMSQ)
Prazo: Baseline
A modification of the Lithium Attitudes Questionnaire (Harvey 1991) which evaluates an individual's attitudes towards mood stabilizing medication (Adams and Scott 2000). The AMSQ comprises 19 items grouped into 7 subscales: general opposition to prophylaxis (4 items), denial of illness severity (3 items), negative attitudes toward drugs in general (3 items), and lack of information about mood stabilizers (1 item). Higher scores on each subscale represent more negative attitudes toward mood stabilizers. Reliability for the 19 items ranges from 57.6 % to 96.9%.
Baseline
Multidimensional Health Locus of Control Scale (MHLC)
Prazo: Baseline
An 18-item instrument that measures three dimensions of locus of control of reinforcement as it pertains to health (internal, IHLC: external-chance, CHLC: and external powerful others, PHLC). Scoring is from 6-36 with higher scores indicating stronger beliefs. The internal consistency reliability using Cronbach's alpha ranges from .67 to .77 for the three dimensions, and the measure has fairly good criterion validity (Wallston 1978).
Baseline
Treatment Adherence
Prazo: Baseline
Treatment adherence will be evaluated in the following three ways: 1) The primary measure will be the Tablet Routines Questionnaire (TRQ, Peet 1991) which is a validated assessment of adherence among individuals with bipolar disorders (Scott 2002, Peet 1991), 2) Blood level of mood stabilizing and antipsychotic medications will be identified from the patient record. This has been identified as a standard of care in numerous guidelines for the treatment of bipolar disorder (American Psychiatric Association 2000, Goldberg 2000). 3) Adherence with clinic visits for the previous three month time period will be calculated as a percentage.
Baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Case Western Reserve University

Colaboradores

National Institute of Mental Health (NIMH)

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de julho de 2004

Conclusão Primária (Real)

1 de novembro de 2006

Conclusão do estudo (Real)

1 de agosto de 2007

Datas de inscrição no estudo

Enviado pela primeira vez

14 de setembro de 2005

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de setembro de 2005

Primeira postagem (Estimativa)

16 de setembro de 2005

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de fevereiro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de fevereiro de 2019

Última verificação

1 de fevereiro de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • K23MH065599-02 (Concessão/Contrato do NIH dos EUA)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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