Culturally Adapted Family Intervention For Psychosis

NCT ID: NCT02167347

Last Updated: 2015-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-12-31

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

Conditions

Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Family Intervention

Culturally Adapted Family intervention for Psychosis Sessions will be offered weekly basis

Group Type: EXPERIMENTAL

Family intervention

Intervention Type: BEHAVIORAL

This 10 session Multi-modal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Family intervention

This 10 session Multi-modal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component

Intervention Type: BEHAVIORAL

Other Intervention Names

Psychosocial intervention

Eligibility 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.

.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manchester

OTHER

Sponsor Role: collaborator

Dow University of Health Sciences

OTHER

Sponsor Role: collaborator

Abbasi Shaheed Hospital

OTHER

Sponsor Role: collaborator

Pakistan Institute of Living and Learning

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nusrat Husain, MD

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Learning and Living, University of Manchester

Imran Chaudhry, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Farooq Naeem, MRCPsych

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Learning and Living, University of Southampton

Raza Ur Rehman, FCPS

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Ajmal kazm

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Living and Learning

Munir Hamirani, FCPS

Role: PRINCIPAL_INVESTIGATOR

Abbasi Shaheed Hospital

Locations

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: DERIVED

PMID: 32930011 (View on PubMed)

Other Identifiers

FINT-PSY-02

Identifier Type: -

Identifier Source: org_study_id