Culturally Adapted Family Intervention For Psychosis

Pilot Study of Culturaly Adapted Family Intervention for Psychosis

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)

Study Overview

• Status: Completed
• Conditions: Psychosis
• Intervention / Treatment: Behavioral: Family intervention

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

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh,
    • Karachi, Sindh,, Pakistan
      • Dow University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Intervention; Culturally Adapted Family intervention for Psychosis Sessions will be offered weekly basis	Behavioral: Family intervention; This 10 session Multi-modal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component; Other Names: Psychosocial intervention
No Intervention: Control; Caregiver ' s Patients who will be randomized to the "treatment as usual" arm will receive routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	six months
Experience of Care-giving inventory(ECI)	Commonly apply to persons who care for relative or friends With a serious mental illness	six months
Carer Wel-Being & Support(CWS)	A questionnaire for carers of people with a mental Health problem	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family Questionnaire(FQ)	Find out the problem of caregiver for relative or friends With a serious mental illness.	six months
Insight rating scale	Assesses Improvement in insight	six months
Calgary Depression Scale for Schizophrenia	This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia	six months
Short Explanatory Model Interview	used to elicit beliefs of mental illness	six months

Collaborators and Investigators

• Sponsor: Pakistan Institute of Living and Learning
• Collaborators: University of Manchester; Dow University of Health Sciences; Abbasi Shaheed Hospital
• Investigators: Principal Investigator: Imran Chaudhry, MD, University of Manchester; Principal Investigator: Nusrat Husain, MD, Pakistan Institute of Learning and Living, University of Manchester; Principal Investigator: Farooq Naeem, MRCPsych, Pakistan Institute of Learning and Living, University of Southampton; Principal Investigator: Munir Hamirani, FCPS, Abbasi Shaheed Hospital; Principal Investigator: Raza Ur Rehman, FCPS, Dow University of Health Sciences; Principal Investigator: Ajmal kazm, Pakistan Institute of Living and Learning

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 17, 2014
• First Submitted That Met QC Criteria: June 18, 2014
• First Posted (Estimate): June 19, 2014

Study Record Updates

• Last Update Posted (Estimate): August 25, 2015
• Last Update Submitted That Met QC Criteria: August 22, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: CBT, Psychosis, cultural adaptation, Pakistan
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: FINT-PSY-02