NCT02210390

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 23, 2016

Status Verified

December 1, 2016

Enrollment Period

2.9 years

First QC Date

August 5, 2014

Last Update Submit

December 21, 2016

Conditions

Bipolar Disorder

Keywords

Psycho-education, Bipolar , cultural adaptation, Pakistan

Outcome Measures

Primary Outcomes (3)

  • 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

  • Knowledge and attitudes

    Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire

    three months

  • 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

Secondary Outcomes (3)

  • Medication adherence

    three months

  • Visual Analogue Scale

    three months

  • Short Explanatory Model Interview

    three months

Study Arms (2)

Intervention

EXPERIMENTAL

Psycho-education Sessions will be offered weekly basis

Behavioral: Psycho education

Control

NO INTERVENTION

Patients who will be randomized to the "treatment as usual" arm will receive routine care

Interventions

Psycho educationBEHAVIORAL

Psycho-education Sessions will be offered weekly basis

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 28155203DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 6, 2014

Study Start

June 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

December 23, 2016

Record last verified: 2016-12

Locations

PA(1)