Clinical trial NCT03762421: Improving Psychological Well-being of Trainee Civil Servants in Pakistan
Official title: Evaluating a Multi-component Group Intervention for Improving Psychological Well-being of Trainee Civil Servants in Pakistan: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Coping Skills
Well-being
Psychological Capital
Anxiety
Lead sponsor: Human Development Research Foundation, Pakistan
Sponsor class: OTHER
Collaborators: name: University of Liverpool
name: Liverpool School of Tropical Medicine
name: Civil Services Academy (CSA), Lahore
First posted: 2018-12-03
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* All newly inducted civil servants attending the CTP at the CSA, Lahore, which is a six months residential training course, and
* who give informed voluntary consent to take part in the study.

Exclusion Criteria:

* Participants having a physical health condition that does not allow them to attend the sessions will be excluded.

Primary outcomes:
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: One of the primary end points is the prevalence of psychological distress at 3 months post intervention
measure: Brief COPE
timeFrame: Another primary end point is the improvement in coping strategies at 3 months post intervention
Secondary outcomes:
measure: Psychological Capital Questionnaire (PCQ)
timeFrame: The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention
measure: Generalized Anxiety Disorder -7 scale (GAD-7)
timeFrame: The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention
measure: WHO-5 well-being index (WHO-5)
timeFrame: The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Human Development Research Foundation
Study officials:
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