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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Sindh
-
Karachi, Sindh, Pakistán
- Dow University of Health Sciences
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿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 |
|---|---|
|
Sin intervención: Control
Los pacientes que serán aleatorizados al brazo de "tratamiento habitual" recibirán atención de rutina
|
|
|
Experimental: Intervention
Psycho-education Sessions will be offered weekly basis
|
Psycho-education Sessions will be offered weekly basis
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Young Mania Rating Scale(YMRS)
Periodo de tiempo: 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
Periodo de tiempo: three months
|
Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire
|
three months
|
|
Beck's Depression Inventory Scale (BDI)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Medication adherence
Periodo de tiempo: three months
|
Self-reported Measure of Medication adherence
|
three months
|
|
Visual Analogue Scale
Periodo de tiempo: three months
|
Patient satisfaction with overall care
|
three months
|
|
Short Explanatory Model Interview
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PSY-BPD-03
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