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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 January 2017 |
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Main ID: |
NCT02210390 |
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Date of registration:
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05/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
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Scientific title:
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Feasibility RCT of the Efficacy of a Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan |
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Date of first enrolment:
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June 2012 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02210390 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Nusrat Husain, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pakistan Institute of Learning and Living, University of Manchester |
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Name:
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Muhammad I Husain, MRCPsych |
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Address:
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Telephone:
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Email:
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Affiliation:
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Camden and Islington NHS Foundation Trust |
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Name:
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Munir Hamirani, FCPS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abbasi Shaheed Hospital |
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Name:
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Raza Ur Rehman, FCPS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dow University of Health Sciences |
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Name:
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Imran Chaudhry, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Manchester |
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Name:
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Ajmal kazm |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pakistan Institute of Learning and Living |
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Name:
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Farooq Naeem, MRCPsych |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pakistan Institute of Learning and Living, University of Southampton |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bipolar Disorder
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Intervention(s)
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Behavioral: Psycho education
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Primary Outcome(s)
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Beck's Depression Inventory Scale (BDI)
[Time Frame: three months]
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Knowledge and attitudes
[Time Frame: three months]
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Young Mania Rating Scale(YMRS)
[Time Frame: three months]
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Secondary Outcome(s)
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Visual Analogue Scale
[Time Frame: three months]
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Short Explanatory Model Interview
[Time Frame: three months]
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Medication adherence
[Time Frame: three months]
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Secondary ID(s)
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PSY-BPD-03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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