Adaptation and Validation of Recent Life Changes Questionnaire for Measuring Stress Among Adults in Karachi, Pakistan

Sponsor
Aga Khan University (Other)
Overall Status
Completed
CT.gov ID
NCT02356263
Collaborator
(none)
300
1
6
49.6

Study Details

Study Description

Brief Summary

Stressors impair optimum function of an individual physiologically and psychologically. Overcoming stress is possible when one knows which aspects of life are the most troublesome to manage for individuals. There are certain tools available in Pakistan that can measures stress in selected populations but there are no validated tools that may quantify stress which results from events occurring in different aspects of life.

Recent Life Changes Questionnaire (RLCQ) is a tool that measures stress of individuals through life changing events. It has five categories; work, home and family, health, personal and social and financial. The objective of the study is to adapt RLCQ and validate it so that it may measure stress among people living in Karachi, Pakistan.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In order to make RLCQ a tool to measure stress within Pakistani context, we would want to adapt RLCQ and then validate it. The study design is a validation study where the construct of recent life changing events will be validated by comparing it with a gold standard to assess the extent of accuracy of measurement by exploring the agreement between them. The mode of data collection is cross-sectional by administering the adapted RLCQ and the gold standard simultaneously. Since stress is a subjective phenomenon and serves as a root cause for many neurodegenerative diseases and mental disorders, a tool for screening mental illnesses is selected against which we could compare the adapted RLCQ for validation. The Mini international neuropsychiatric Interviews (MINI) is a structured diagnostic interview developed and validated by Sheehan in 1997, Florida. It is based on the DSM IV criteria and ICD-10. The design of this study incorporates content and criterion validity as we have a pre-existing 'gold standard' which is widely accepted and is in current practice of mental health screening in Pakistan.

    The study will be conducted in six phases. Phase I includes conducting qualitative interviews to explore the phenomenon. In Phase II, adaptation of RLCQ will be done and review of the adapted tool will be done with the help of subject experts. Phase III will verify the face validity of the tool by translations and back translations. In Phase IV, pre-testing of the tool will be done whereas in phase V, we will administer the tool in the community along with conducting MINI interviews. Phase VI tests the reliability of the tool.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Time Perspective:
    Cross-Sectional
    Official Title:
    Adaptation and Validation of Recent Life Changes Questionnaire (RLCQ) to Measure Stress Among Adult Population of Karachi, Pakistan.
    Study Start Date :
    Mar 1, 2015
    Actual Primary Completion Date :
    Jul 1, 2015
    Actual Study Completion Date :
    Sep 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity and specificity, as measured by Positive and Negative Predictive Value, Kappa Statistics [11 months]

      sensitivity and specificity of the RLCQ will be compared against gold standard MINI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adults aged 18 years or above

    • Those who would stay in the study site for at least one month

    • Those who provide a written informed consent

    Exclusion Criteria:
    • Those who do not understand Urdu

    • Those who have cognitive or hearing difficulties

    • People with known psychiatric conditions and are under treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aga Khan University Karachi Pakistan

    Sponsors and Collaborators

    • Aga Khan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Ayeesha Kamran Kamal, Associate Professor Neurology,Director Stroke Fellowship Program, Aga Khan University
    ClinicalTrials.gov Identifier:
    NCT02356263
    Other Study ID Numbers:
    • 3235-CHS-ERC-14
    First Posted:
    Feb 5, 2015
    Last Update Posted:
    Aug 8, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by Dr. Ayeesha Kamran Kamal, Associate Professor Neurology,Director Stroke Fellowship Program, Aga Khan University

    Study Results

    No Results Posted as of Aug 8, 2016