NCT02167347

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

2.4 years

First QC Date

June 17, 2014

Last Update Submit

August 22, 2015

Conditions

Keywords

CBT, Psychosis, cultural adaptation, Pakistan

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Family Questionnaire(FQ)

    six months

  • Insight rating scale

    six months

  • Calgary Depression Scale for Schizophrenia

    six months

  • Short Explanatory Model Interview

    six months

Study Arms (2)

Family Intervention

EXPERIMENTAL

Culturally Adapted Family intervention for Psychosis Sessions will be offered weekly basis

Behavioral: Family intervention

Control

NO INTERVENTION

Caregiver ' s Patients who will be randomized to the "treatment as usual" arm will receive routine care

Interventions

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

Also known as: Psychosocial intervention
Family Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychotic DisordersColor Vision Defects

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesCone DystrophyEye Diseases, HereditaryEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Nusrat Husain, MD

    Pakistan Institute of Learning and Living, University of Manchester

    PRINCIPAL INVESTIGATOR
  • Imran Chaudhry, MD

    University of Manchester

    PRINCIPAL INVESTIGATOR
  • Farooq Naeem, MRCPsych

    Pakistan Institute of Learning and Living, University of Southampton

    PRINCIPAL INVESTIGATOR
  • Raza Ur Rehman, FCPS

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Ajmal kazm

    Pakistan Institute of Living and Learning

    PRINCIPAL INVESTIGATOR
  • Munir Hamirani, FCPS

    Abbasi Shaheed Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 19, 2014

Study Start

February 1, 2012

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations