Culturally Adapted Family Intervention For Psychosis
Primary Purpose
Psychosis
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Family intervention
Sponsored by
About this trial
This is an interventional health services research trial for Psychosis focused on measuring CBT, Psychosis, cultural adaptation, Pakistan
Eligibility Criteria
Inclusion Criteria:
- 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.
- Individuals aged between 18-65.
- Resident of Karachi.
- Participant is able to give informed written consent.
Exclusion Criteria:
- Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).
Unstable residential arrangements such that the likelihood of being available for the duration of the trial is low.
.
Sites / Locations
- Dow University of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Family Intervention
Control
Arm Description
Culturally Adapted Family intervention for Psychosis Sessions will be offered weekly basis
Caregiver ' s Patients who will be randomized to the "treatment as usual" arm will receive routine care
Outcomes
Primary Outcome Measures
Positive and Negative syndrome scale (PANSS)
The PANSS is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale.
Experience of Care-giving inventory(ECI)
Commonly apply to persons who care for relative or friends With a serious mental illness
Carer Wel-Being & Support(CWS)
A questionnaire for carers of people with a mental Health problem
Secondary Outcome Measures
Family Questionnaire(FQ)
Find out the problem of caregiver for relative or friends With a serious mental illness.
Insight rating scale
Assesses Improvement in insight
Calgary Depression Scale for Schizophrenia
This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia
Short Explanatory Model Interview
used to elicit beliefs of mental illness
Full Information
NCT ID
NCT02167347
First Posted
June 17, 2014
Last Updated
August 22, 2015
Sponsor
Pakistan Institute of Living and Learning
Collaborators
University of Manchester, Dow University of Health Sciences, Abbasi Shaheed Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02167347
Brief Title
Culturally Adapted Family Intervention For Psychosis
Official Title
Pilot Study of Culturaly Adapted Family Intervention for Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning
Collaborators
University of Manchester, Dow University of Health Sciences, Abbasi Shaheed Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim:
To assess the feasibility of culturally adapted Family Intervention for Psychosis.
Design:
Randomized Control Trial
Setting:
psychiatric department of different hospitals
Participants:
A total of 36 caregivers of Psychosis patients will be randomized to psychological Intervention and treatment as usual arm.
Intervention:
Culturally Adapted Family Intervention for Psychosis
Outcome measure:
Positive and Negative syndrome scale (PANSS) Experience of care -giving inventory(ECI) Care Well-Being & Support(CWS)
Detailed Description
The purpose of the study is to test the feasibility of culturally adaptive family intervention for Psychosis
Primary Objective :
To test whether Pakistani families caring for someone with psychosis will engage with a model of family intervention which has been culturally adapted to meet their needs.
To evaluate the acceptability of the intervention to the families who receive it and to gather feedback regarding any changes that might improve the intervention.
To gain an impression of whether the intervention has the potential to address unmet psychological and social needs of the families and how this affects their levels of stress
the investigators will conduct a feasibility pilot study to test whether Pakistani families offered the intervention will want to receive it. 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 ten sessions of family intervention will be provided by trained research clinician during the period of three months. Relatives of Patients in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested families will be offered family intervention
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
CBT, Psychosis, cultural adaptation, Pakistan
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family Intervention
Arm Type
Experimental
Arm Description
Culturally Adapted Family intervention for Psychosis Sessions will be offered weekly basis
Arm Title
Control
Arm Type
No Intervention
Arm Description
Caregiver ' s Patients who will be randomized to the "treatment as usual" arm will receive routine care
Intervention Type
Behavioral
Intervention Name(s)
Family intervention
Other Intervention Name(s)
Psychosocial intervention
Intervention Description
This 10 session Multi-modal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component
Primary Outcome Measure Information:
Title
Positive and Negative syndrome scale (PANSS)
Description
The PANSS is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale.
Time Frame
six months
Title
Experience of Care-giving inventory(ECI)
Description
Commonly apply to persons who care for relative or friends With a serious mental illness
Time Frame
six months
Title
Carer Wel-Being & Support(CWS)
Description
A questionnaire for carers of people with a mental Health problem
Time Frame
six months
Secondary Outcome Measure Information:
Title
Family Questionnaire(FQ)
Description
Find out the problem of caregiver for relative or friends With a serious mental illness.
Time Frame
six months
Title
Insight rating scale
Description
Assesses Improvement in insight
Time Frame
six months
Title
Calgary Depression Scale for Schizophrenia
Description
This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia
Time Frame
six months
Title
Short Explanatory Model Interview
Description
used to elicit beliefs of mental illness
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Individuals aged between 18-65.
Resident of Karachi.
Participant is able to give informed written consent.
Exclusion Criteria:
Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).
Unstable residential arrangements such that the likelihood of being available for the duration of the trial is low.
.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nusrat Husain, MD
Organizational Affiliation
Pakistan Institute of Learning and Living, University of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Imran Chaudhry, MD
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Farooq Naeem, MRCPsych
Organizational Affiliation
Pakistan Institute of Learning and Living, University of Southampton
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raza Ur Rehman, FCPS
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ajmal kazm
Organizational Affiliation
Pakistan Institute of Living and Learning
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Munir Hamirani, FCPS
Organizational Affiliation
Abbasi Shaheed Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh,
Country
Pakistan
12. IPD Sharing Statement
Citations:
PubMed Identifier
32930011
Citation
Husain MO, Khoso AB, Renwick L, Kiran T, Saeed S, Lane S, Naeem F, Chaudhry IB, Husain N. Culturally adapted family intervention for schizophrenia in Pakistan: a feasibility study. Int J Psychiatry Clin Pract. 2021 Sep;25(3):258-267. doi: 10.1080/13651501.2020.1819332. Epub 2020 Sep 15.
Results Reference
derived
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Culturally Adapted Family Intervention For Psychosis
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