Ignite Creation Date:
2024-05-06 @ 12:28 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03762421
Status:
COMPLETED
Last Update Posted:
2022-08-04
First Post:
2018-11-30
Brief Title:
Improving Psychological Well-being of Trainee Civil Servants in Pakistan
Sponsor:
Human Development Research Foundation Pakistan
Organization:
Human Development Research Foundation Pakistan
Study Overview
Official Title:
Evaluating a Multi-component Group Intervention for Improving Psychological Well-being of Trainee Civil Servants in Pakistan a Randomised Controlled Study
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n240 undergoing a 6 months induction training The participants will be randomised on a 11 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 Fishers 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
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 n240 undergoing a 6 months induction training The participants will be randomised on a 11 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 Fishers 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None