Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Feasibility RCT of the Efficacy of a Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Behavioral: Psycho education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Psycho-education Sessions will be offered weekly basis | Behavioral: Psycho education<br>* Psycho-education Sessions will be offered weekly basis<br>|
| No Intervention: Control<br>Patients who will be randomized to the treatment as usual arm will receive routine care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Young Mania Rating Scale(YMRS) | The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms | three months | 
| Knowledge and attitudes | Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire | three months | 
| Beck's Depression Inventory Scale (BDI) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | Self-reported Measure of Medication adherence | three months | 
| Visual Analogue Scale | Patient satisfaction with overall care | three months | 
| Short Explanatory Model Interview | used to elicit beliefs of mental illness | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psycho-education, Bipolar , cultural adaptation, Pakistan