Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan

December 21, 2016 updated by: Pakistan Institute of Living and Learning

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Dow University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
three months
Knowledge and attitudes
Time Frame: three months
Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire
three months
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.
three months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Living and Learning

Collaborators

University of Manchester
Dow University of Health Sciences
Abbasi Shaheed Hospital

Investigators

  • Principal Investigator: Imran Chaudhry, MD, University of Manchester
  • Principal Investigator: Nusrat Husain, MD, Pakistan Institute of Learning and Living, University of Manchester
  • Principal Investigator: Farooq Naeem, MRCPsych, Pakistan Institute of Learning and Living, University of Southampton
  • Principal Investigator: Munir Hamirani, FCPS, Abbasi Shaheed Hospital
  • Principal Investigator: Raza Ur Rehman, FCPS, Dow University of Health Sciences
  • Principal Investigator: Ajmal kazm, Pakistan Institute of Living and Learning
  • Principal Investigator: Muhammad I Husain, MRCPsych, Camden and Islington NHS foundation trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

August 5, 2014

First Submitted That Met QC Criteria

August 5, 2014

First Posted (Estimate)

August 6, 2014

Study Record Updates

Last Update Posted (Estimate)

December 23, 2016

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSY-BPD-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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