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Metadata

Name
Improving Psychological Well-being of Trainee Civil Servants in Pakistan
Repository
ClinicalTrials.gov
Identifier
clinicaltrials:NCT03762421
Description
Political and civil instability in Pakistan has placed many segments of society under stress.
A 5-session group intervention incorporating principles of stress management, problem
solving, behavioural activation, peer-support and adaptive leadership has been developed and
successfully piloted for business professionals working under stressful conditions in
Pakistan. The aim of this study is to evaluate the effectiveness of an adapted version of the
intervention in improving psychological well-being amongst a group of trainee civil servants
in the country.

A two-arm single blind, randomised controlled trial of the group intervention will be
conducted among trainee civil servants in Pakistan. The participants are newly inducted civil
servants (n=240) undergoing a 6 months' induction training. The participants will be
randomised on a 1:1 allocation ratio (120 in each arm), with the intervention arm receiving
the group intervention integrated into their orientation sessions and the control arm
receiving orientation sessions alone. Outcome assessments will be conducted immediately
post-intervention and 3 months after the completion of the intervention. The primary outcomes
will be change in the prevalence of psychological distress as measured by Patient Health
Questionnaire-9 (PHQ-9) and improvement in coping strategies as measured by Brief Cope
Questionnaire. Secondary outcomes include symptoms of anxiety (measured by Generalized
Anxiety Disorder scale (GAD-7)), well-being (measured by WHO5 well-being index) and
psychological capital (measured by Psychological Capital Questionnaire).

The primary analyses will be intent-to-treat consisting of all participants included,
according to the groups in which they will be randomized. The primary analysis will involve
comparing pre to post changes in prevalence of psychological distress and coping strategies
of the participants randomly assigned to the two conditions, using Fisher's exact test.
Primary analyses will be non-parametric tests; however sensitivity analyses will use
parametric models such as linear and logistic regression to control for baseline values of
the participants' characteristics.

Ethical principles of voluntary informed consent, maintaining anonymity and confidentiality,
data management and storage will be followed.
Data or Study Types
clinical trial
Source Organization
Unknown
Access Conditions
available
Year
2018
Access Hyperlink
https://clinicaltrials.gov/ct2/show/NCT03762421

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