This trial has been completed.

Condition bipolar disorder
Treatment psycho education
Sponsor Pakistan Institute of Learning and Living
Collaborator University of Manchester
Start date June 2012
End date May 2015
Trial size 36 participants
Trial identifier NCT02210390, PSY-BPD-03



To assess the Feasibility RCT of the efficacy of a culturally adapted psychological intervention for Bipolar disorder in Pakistan


Randomized Control Trial


Psychiatric Departments of different Hospitals in Karachi.


A total of 36 Bipolar disorder patients will be randomized to psychological Intervention and treatment as usual arm.


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Psycho-education Sessions will be offered weekly basis
psycho education
Psycho-education Sessions will be offered weekly basis
(No Intervention)
Patients who will be randomized to the "treatment as usual" arm will receive routine care

Primary Outcomes

Young Mania Rating Scale(YMRS)
time frame: three months
Knowledge and attitudes
time frame: three months
Beck's Depression Inventory Scale (BDI)
time frame: three months

Secondary Outcomes

Medication adherence
time frame: three months
Visual Analogue Scale
time frame: three months
Short Explanatory Model Interview
time frame: three months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Feasibility RCT of the Efficacy of a Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
Principal investigator Nusrat Husain, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Pakistan Institute of Learning and Living.