Culturally Adapted Family Intervention For Psychosis

Pakistan Institute of Living and Learning36 enrolled

Overview

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)

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Psychosis

Interventions

Family interventionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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. .

Locations (1)

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

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.

Time frame: six months

Experience of Care-giving inventory(ECI)

Commonly apply to persons who care for relative or friends With a serious mental illness

Time frame: six months

Carer Wel-Being & Support(CWS)

A questionnaire for carers of people with a mental Health problem

Time frame: six months

Secondary Outcomes

Family Questionnaire(FQ)

Find out the problem of caregiver for relative or friends With a serious mental illness.

Time frame: six months

Insight rating scale

Assesses Improvement in insight

Time frame: six months

Calgary Depression Scale for Schizophrenia

This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia

Time frame: six months

Short Explanatory Model Interview

used to elicit beliefs of mental illness

Time frame: six months

Data from ClinicalTrials.gov

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