Anxiety Clinical Trial - Improving Psychological Well-being of Trainee

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03762421
Study type	Interventional
Source	Human Development Research Foundation, Pakistan
Contact
Status	Completed
Phase	N/A
Start date	December 1, 2018
Completion date	September 30, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Improving Psychological Well-being of Trainee Civil Servants in Pakistan

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms