Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
Feasibility RCT of the Efficacy of a Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
Aim:
To assess the Feasibility RCT of the efficacy of a culturally adapted psychological intervention for Bipolar disorder in Pakistan
Design:
Randomized Control Trial
Setting:
Psychiatric Departments of different Hospitals in Karachi.
Participants:
A total of 36 Bipolar disorder patients will be randomized to psychological Intervention and treatment as usual arm.
Intervention:
Culturally Adapted psychological intervention for bipolar disorder
Outcome measure:
- Acceptance of intervention in terms of attending session and dropouts
- Knowledge and attitudes towards bipolar disorder
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The purpose of the study is to test Feasibility RCT of the efficacy of a culturally adapted psychological intervention for Bipolar disorder in Pakistan
Primary Objectives :
- To determine effectiveness of educational intervention in terms of patient Satisfaction with overall care, knowledge and attitudes to bipolar disorder and medication adherence.
To assess feasibility in terms of
- Recruitment
- Using instruments that will be used to assess recurrence rate in the main study (BDI, YMRS and obtaining prospective hospitalisation and medication data)
- acceptability of a culturally adapted bipolar group education package
- To allow 'fine tuning' of culturally adapted bipolar group education package (this will partly be achieved by using the SEMI at study entry)
The Participants will be recruited from psychiatric department of different hospitals.
They will be randomly divided into two groups; intervention group and treatment-as-usual group. A total of thirty six participants will be recruited in the pilot study and divided equally into two arms. This will ensure that, even after loss to follow-up, we will have at least 12 subjects per group for analysis (FDA guidance http://www.fda.gov/cder/guidance/5356fnl.pdf) .Randomization will be carried out by the on offsite statistician. This will provide a reliable geographically remote service. For intervention group twelve sessions of psychoeducation will be provided by trained research clinician during the period of three months. Patients in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested patients will be offered psychoeducation.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Sindh
-
Karachi, Sindh, Paquistão
- Dow University of Health Sciences
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Diagnosis of DSM IV Bipolar disorder
- Currently stable (YMRS <8, BDI<12)
- Age 18 to 65 years.
- Participants engaged with the mental health services since last 6 months.
- Able to give written informed consent.
- Resident of trial catchments area
- Ability to speak Urdu /Punjabi
Exclusion Criteria:
- Substance or alcohol dependent (i.e., those who fulfill the criteria for dependence according to DSM IV criteria)
- Inability to engage fully in the psychotherapy (due to cognitive impairment)
- Actively suicidal
- Any major psychiatric illness other than bipolar disorder
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 |
|---|---|
|
Sem intervenção: Ao controle
Os pacientes que serão randomizados para o braço "tratamento como de costume" receberão cuidados de rotina
|
|
|
Experimental: Intervention
Psycho-education Sessions will be offered weekly basis
|
Psycho-education Sessions will be offered weekly basis
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Young Mania Rating Scale(YMRS)
Prazo: three months
|
The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms
|
three months
|
|
Knowledge and attitudes
Prazo: three months
|
Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire
|
three months
|
|
Beck's Depression Inventory Scale (BDI)
Prazo: three months
|
The BDI is a measure of depression severity and has been used in several previous studies in Pakistan and is validated for use in Urdu.
|
three months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Medication adherence
Prazo: three months
|
Self-reported Measure of Medication adherence
|
three months
|
|
Visual Analogue Scale
Prazo: three months
|
Patient satisfaction with overall care
|
three months
|
|
Short Explanatory Model Interview
Prazo: three months
|
used to elicit beliefs of mental illness
|
three months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Imran Chaudhry, MD, University of Manchester
- Investigador principal: Nusrat Husain, MD, Pakistan Institute of Learning and Living, University of Manchester
- Investigador principal: Farooq Naeem, MRCPsych, Pakistan Institute of Learning and Living, University of Southampton
- Investigador principal: Munir Hamirani, FCPS, Abbasi Shaheed Hospital
- Investigador principal: Raza Ur Rehman, FCPS, Dow University of Health Sciences
- Investigador principal: Ajmal kazm, Pakistan Institute of Living and Learning
- Investigador principal: Muhammad I Husain, MRCPsych, Camden and Islington NHS foundation trust
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- PSY-BPD-03
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