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Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan

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ClinicalTrials.gov Identifier: NCT02210390
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : December 23, 2016
Sponsor:
Collaborators:
University of Manchester
Dow University of Health Sciences
Abbasi Shaheed Hospital
Information provided by (Responsible Party):
Pakistan Institute of Living and Learning

Study Description
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Brief Summary:

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: Psycho education Not Applicable

Detailed Description:

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 :

  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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility RCT of the Efficacy of a Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
Study Start Date : June 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Psycho-education Sessions will be offered weekly basis
 Behavioral: Psycho education
Psycho-education Sessions will be offered weekly basis
No Intervention: Control
Patients who will be randomized to the "treatment as usual" arm will receive routine care


Outcome Measures
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Primary Outcome Measures :
  1. Young Mania Rating Scale(YMRS) [ Time Frame: three months ]
    The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms

  2. Knowledge and attitudes [ Time Frame: three months ]
    Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire

  3. Beck's Depression Inventory Scale (BDI) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Medication adherence [ Time Frame: three months ]
    Self-reported Measure of Medication adherence

  2. Visual Analogue Scale [ Time Frame: three months ]
    Patient satisfaction with overall care

  3. Short Explanatory Model Interview [ Time Frame: three months ]
    used to elicit beliefs of mental illness


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210390


Locations
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Pakistan
Dow University of Health Sciences
Karachi, Sindh, Pakistan
Sponsors and Collaborators
Pakistan Institute of Living and Learning
University of Manchester
Dow University of Health Sciences
Abbasi Shaheed Hospital
Investigators
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Principal Investigator: Nusrat Husain, MD Pakistan Institute of Learning and Living, University of Manchester
Principal Investigator: Imran Chaudhry, MD University of Manchester
Principal Investigator: Farooq Naeem, MRCPsych Pakistan Institute of Learning and Living, University of Southampton
Principal Investigator: Raza Ur Rehman, FCPS Dow University of Health Sciences
Principal Investigator: Ajmal kazm Pakistan Institute of Living and Learning
Principal Investigator: Munir Hamirani, FCPS Abbasi Shaheed Hospital
Principal Investigator: Muhammad I Husain, MRCPsych Camden and Islington NHS Foundation Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pakistan Institute of Living and Learning
ClinicalTrials.gov Identifier: NCT02210390    
Other Study ID Numbers: PSY-BPD-03
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Keywords provided by Pakistan Institute of Living and Learning:
Psycho-education, Bipolar , cultural adaptation, Pakistan
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders