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Completed

NCT Number: NCT02167347

Culturally Adapted Family Intervention For Psychosis

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)

Completed

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Key information

Conditions

Psychosis Color Vision Defects Cone Dystrophy Eye Diseases Eye Diseases, Hereditary Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dow University of Health Sciences

Karachi, Sindh, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

.

Treatment and study plan

Family intervention

Behavioral

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

Other names: Psychosocial intervention

Primary outcomes

  1. Positive and Negative syndrome scale (PANSS)

    Time frame: six months

    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.

  2. Experience of Care-giving inventory(ECI)

    Time frame: six months

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

  3. Carer Wel-Being & Support(CWS)

    Time frame: six months

    A questionnaire for carers of people with a mental Health problem

Secondary outcomes

  1. Family Questionnaire(FQ)

    Time frame: six months

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

  2. Insight rating scale

    Time frame: six months

    Assesses Improvement in insight

  3. Calgary Depression Scale for Schizophrenia

    Time frame: six months

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

  4. Short Explanatory Model Interview

    Time frame: six months

    used to elicit beliefs of mental illness

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Collaborators

  • Abbasi Shaheed Hospital
  • Dow University of Health Sciences
  • University of Manchester

Registry information

Official study title

Pilot Study of Culturaly Adapted Family Intervention for Psychosis

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 19, 2014
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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