Culturally Adapted Family Intervention For Psychosis

Psychosis Clinical Trial

Official title:

Pilot Study of Culturaly Adapted Family Intervention for Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167347
• Other study ID #: FINT-PSY-02
• Status: Completed
• Phase: N/A
• First received: June 17, 2014
• Last updated: August 22, 2015
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Pakistan Institute of Learning and Living
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Family intervention
This 10 session Multi-modal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component

Locations

Country	Name	City	State
Pakistan	Dow University of Health Sciences	Karachi	Sindh,

Sponsors (4)

Lead Sponsor	Collaborator
Pakistan Institute of Learning and Living	Abbasi Shaheed Hospital, Dow University of Health Sciences, University of Manchester

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Experience of Care-giving inventory(ECI)	Commonly apply to persons who care for relative or friends With a serious mental illness	six months	No
Primary	Carer Wel-Being & Support(CWS)	A questionnaire for carers of people with a mental Health problem	six months	No
Secondary	Family Questionnaire(FQ)	Find out the problem of caregiver for relative or friends With a serious mental illness.	six months	No
Secondary	Insight rating scale	Assesses Improvement in insight	six months	No
Secondary	Calgary Depression Scale for Schizophrenia	This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia	six months	No
Secondary	Short Explanatory Model Interview	used to elicit beliefs of mental illness	six months	No