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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 31 August 2015
Main ID:  NCT02167347
Date of registration: 17/06/2014
Prospective Registration: No
Primary sponsor: Pakistan Institute of Learning and Living
Public title: Culturally Adapted Family Intervention For Psychosis
Scientific title: Pilot Study of Culturaly Adapted Family Intervention for Psychosis
Date of first enrolment: February 2012
Target sample size: 36
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02167347
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research  
Phase:  N/A
Countries of recruitment
Pakistan
Contacts
Name:     Ajmal kazm
Address: 
Telephone:
Email:
Affiliation:  Pakistan Institute of Learning and Living
Name:     Nusrat Husain, MD
Address: 
Telephone:
Email:
Affiliation:  Pakistan Institute of Learning and Living, University of Manchester
Name:     Raza Ur Rehman, FCPS
Address: 
Telephone:
Email:
Affiliation:  Dow University of Health Sciences
Name:     Imran Chaudhry, MD
Address: 
Telephone:
Email:
Affiliation:  University of Manchester
Name:     Munir Hamirani, FCPS
Address: 
Telephone:
Email:
Affiliation:  Abbasi Shaheed Hospital
Name:     Farooq Naeem, MRCPsych
Address: 
Telephone:
Email:
Affiliation:  Pakistan Institute of Learning and Living, University of Southampton
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Living with or with at least 10 hours per week face to face contact with an
individual with psychosis who has a caring role. Plus the individual with psychosis
themselves.

2. Individuals aged between 18-65.

3. Resident of Karachi.

4. Participant is able to give informed written consent.

Exclusion Criteria:

1. Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence
according to ICD10 RDC).

2. Unstable residential arrangements such that the likelihood of being available for the
duration of the trial is low.

.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Psychosis
Intervention(s)
Behavioral: Family intervention
Primary Outcome(s)
Experience of Care-giving inventory(ECI) [Time Frame: six months]
Carer Wel-Being & Support(CWS) [Time Frame: six months]
Positive and Negative syndrome scale (PANSS) [Time Frame: six months]
Secondary Outcome(s)
Calgary Depression Scale for Schizophrenia [Time Frame: six months]
Insight rating scale [Time Frame: six months]
Short Explanatory Model Interview [Time Frame: six months]
Family Questionnaire(FQ) [Time Frame: six months]
Secondary ID(s)
FINT-PSY-02
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Manchester
Abbasi Shaheed Hospital
Dow University of Health Sciences
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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