Clinical trial NCT02167347: Culturally Adapted Family Intervention For Psychosis
Official title: Pilot Study of Culturaly Adapted Family Intervention for Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Keywords: CBT, Psychosis, cultural adaptation, Pakistan
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: Dow University of Health Sciences
name: Abbasi Shaheed Hospital
First posted: 2014-06-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

   .

Primary outcomes:
measure: Positive and Negative syndrome scale (PANSS)
timeFrame: six months
measure: Experience of Care-giving inventory(ECI)
timeFrame: six months
measure: Carer Wel-Being & Support(CWS)
timeFrame: six months
Secondary outcomes:
measure: Family Questionnaire(FQ)
timeFrame: six months
measure: Insight rating scale
timeFrame: six months
measure: Calgary Depression Scale for Schizophrenia
timeFrame: six months
measure: Short Explanatory Model Interview
timeFrame: six months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh,
Study officials:
affiliation: Pakistan Institute of Learning and Living, University of Manchester
name: Nusrat Husain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Imran Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pakistan Institute of Learning and Living, University of Southampton
name: Farooq Naeem, MRCPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: Dow University of Health Sciences
name: Raza Ur Rehman, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Pakistan Institute of Living and Learning
name: Ajmal kazm
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbasi Shaheed Hospital
name: Munir Hamirani, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.