Clinical trial NCT02210390: Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
Official title: Feasibility RCT of the Efficacy of a Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Psycho-education, Bipolar , cultural adaptation, Pakistan
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: Dow University of Health Sciences
name: Abbasi Shaheed Hospital
First posted: 2014-08-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Young Mania Rating Scale(YMRS)
timeFrame: three months
measure: Knowledge and attitudes
timeFrame: three months
measure: Beck's Depression Inventory Scale (BDI)
timeFrame: three months
Secondary outcomes:
measure: Medication adherence
timeFrame: three months
measure: Visual Analogue Scale
timeFrame: three months
measure: Short Explanatory Model Interview
timeFrame: three months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
affiliation: Pakistan Institute of Learning and Living, University of Manchester
name: Nusrat Husain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Imran Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pakistan Institute of Learning and Living, University of Southampton
name: Farooq Naeem, MRCPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: Dow University of Health Sciences
name: Raza Ur Rehman, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Pakistan Institute of Living and Learning
name: Ajmal kazm
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbasi Shaheed Hospital
name: Munir Hamirani, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Camden and Islington NHS Foundation Trust
name: Muhammad I Husain, MRCPsych
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.