Culturally Adapted Family Intervention For Psychosis

Study Overview
=================
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

Official Title
-----------------
Pilot Study of Culturaly Adapted Family Intervention for Psychosis

Conditions
-----------------
Psychosis

Intervention / Treatment
-----------------
* Behavioral: Family intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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. .

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Intervention<br>Culturally Adapted Family intervention for Psychosis Sessions will be offered weekly basis | Behavioral: Family intervention<br>* This 10 session Multi-modal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component<br>* Other names: Psychosocial intervention;|
| No Intervention: Control<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CBT, Psychosis, cultural adaptation, Pakistan