Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210390
• Other study ID #: PSY-BPD-03
• Status: Completed
• Phase: N/A
• First received: August 5, 2014
• Last updated: December 21, 2016
• Start date: June 2012
• Est. completion date: May 2015

Study information

• Verified date: December 2016
• Source: Pakistan Institute of Learning and Living
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Behavioral:
• Psycho education
Psycho-education Sessions will be offered weekly basis

Locations

Country	Name	City	State
Pakistan	Dow University of Health Sciences	Karachi	Sindh

Sponsors (4)

Lead Sponsor	Collaborator
Pakistan Institute of Learning and Living	Abbasi Shaheed Hospital, Dow University of Health Sciences, University of Manchester

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Knowledge and attitudes	Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire	three months	No
Primary	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	Yes
Secondary	Medication adherence	Self-reported Measure of Medication adherence	three months	No
Secondary	Visual Analogue Scale	Patient satisfaction with overall care	three months	No
Secondary	Short Explanatory Model Interview	used to elicit beliefs of mental illness	three months	No