Culturally Adapted Family Intervention For Psychosis

Pakistan Institute of Living and Learning

Status

Completed

Conditions

Psychosis

Treatments

Behavioral: Family intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02167347

FINT-PSY-02

Details and patient eligibility

About

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)

Full 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

Enrollment

36 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

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