Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
NCT ID: NCT02210390
Last Updated: 2016-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2012-06-30
2015-05-31
Brief Summary
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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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Primary Objectives :
1. To determine effectiveness of educational intervention in terms of patient Satisfaction with overall care, knowledge and attitudes to bipolar disorder and medication adherence.
2. 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
3. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention
Psycho-education Sessions will be offered weekly basis
Psycho education
Psycho-education Sessions will be offered weekly basis
Control
Patients who will be randomized to the "treatment as usual" arm will receive routine care
No interventions assigned to this group
Interventions
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Psycho education
Psycho-education Sessions will be offered weekly basis
Eligibility Criteria
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Inclusion Criteria
* 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
* Inability to engage fully in the psychotherapy (due to cognitive impairment)
* Actively suicidal
* Any major psychiatric illness other than bipolar disorder
18 Years
65 Years
ALL
No
Sponsors
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University of Manchester
OTHER
Dow University of Health Sciences
OTHER
Abbasi Shaheed Hospital
OTHER
Pakistan Institute of Living and Learning
OTHER
Responsible Party
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Principal Investigators
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Nusrat Husain, MD
Role: PRINCIPAL_INVESTIGATOR
Pakistan Institute of Learning and Living, University of Manchester
Imran Chaudhry, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manchester
Farooq Naeem, MRCPsych
Role: PRINCIPAL_INVESTIGATOR
Pakistan Institute of Learning and Living, University of Southampton
Raza Ur Rehman, FCPS
Role: PRINCIPAL_INVESTIGATOR
Dow University of Health Sciences
Ajmal kazm
Role: PRINCIPAL_INVESTIGATOR
Pakistan Institute of Living and Learning
Munir Hamirani, FCPS
Role: PRINCIPAL_INVESTIGATOR
Abbasi Shaheed Hospital
Muhammad I Husain, MRCPsych
Role: PRINCIPAL_INVESTIGATOR
Camden and Islington NHS Foundation Trust
Locations
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Dow University of Health Sciences
Karachi, Sindh, Pakistan
Countries
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References
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Husain MI, Chaudhry IB, Rahman RR, Hamirani MM, Mehmood N, Haddad PM, Hodsoll J, Young AH, Naeem F, Husain N. Pilot study of a culturally adapted psychoeducation (CaPE) intervention for bipolar disorder in Pakistan. Int J Bipolar Disord. 2017 Dec;5(1):3. doi: 10.1186/s40345-017-0074-8. Epub 2017 Feb 11.
Other Identifiers
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PSY-BPD-03
Identifier Type: -
Identifier Source: org_study_id