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

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ClinicalTrials.gov Identifier: NCT02356263
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Ayeesha Kamran Kamal, Aga Khan University

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
Life Change Events

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 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 : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015



Primary Outcome Measures :
  1. Sensitivity and specificity, as measured by Positive and Negative Predictive Value, Kappa Statistics [ Time Frame: 11 months ]
    sensitivity and specificity of the RLCQ will be compared against gold standard MINI



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The target population for the study includes all adults aged 18 years or above living in Karachi, Pakistan. The source population is that of all adults aged 18 years or above living in Gulshan-e-Iqbal town Karachi from where we will draw our sample population comprising of those adults 18 years or more who fulfil the eligibility criteria and consent to participate in the study.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356263


Locations
Pakistan
Aga Khan University
Karachi, Pakistan
Sponsors and Collaborators
Aga Khan University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ayeesha Kamran Kamal, Associate Professor Neurology,Director Stroke Fellowship Program, Aga Khan University
ClinicalTrials.gov Identifier: NCT02356263     History of Changes
Other Study ID Numbers: 3235-CHS-ERC-14
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016

Keywords provided by Dr. Ayeesha Kamran Kamal, Aga Khan University:
stressful events
psychological stress
life experiences