NCT02356263

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

January 28, 2015

Last Update Submit

August 5, 2016

Conditions

Keywords

stressful eventspsychological stresslife experiences

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity, as measured by Positive and Negative Predictive Value, Kappa Statistics

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

    11 months

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Those who do not understand Urdu
  • Those who have cognitive or hearing difficulties
  • People with known psychiatric conditions and are under treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Pakistan

Location

Related Publications (2)

  • Artani A, Kamal AK, Azam SI, Artani M, Bhamani SS, Saif M, Khan FA, Alam N. Validation of the Recent Life Changes Questionnaire (RLCQ) for stress measurement among adults residing in urban communities in Pakistan. BMC Psychol. 2019 Oct 21;7(1):66. doi: 10.1186/s40359-019-0341-9.

  • Artani A, Bhamani SS, Azam I, AbdulSultan M, Khoja A, Kamal AK. Adaptation of the Recent Life Changes Questionnaire (RLCQ) to measure stressful life events in adults residing in an urban megapolis in Pakistan. BMC Psychiatry. 2017 May 5;17(1):169. doi: 10.1186/s12888-017-1315-1.

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Neurology,Director Stroke Fellowship Program

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 5, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

August 8, 2016

Record last verified: 2016-08

Locations