Improving Psychological Well-being of Trainee Civil Servants in Pakistan

Anxiety Clinical Trial

Official title:

Evaluating a Multi-component Group Intervention for Improving Psychological Well-being of Trainee Civil Servants in Pakistan: a Randomised Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03762421
• Other study ID #: 2018-CS PM+
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: August 2022
• Source: Human Development Research Foundation, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 30, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Coping Skills
• Psychological Capital
• Psychological Distress
• Well-being

Intervention

Behavioral:
• Psycho-social skills development workshops based on PM plus
5 weekly, psycho-social skills development workshops will be conducted for newly inducted civil servants in groups, based on the problem management plus intervention. These workshops will be integrated into routine induction sessions of trainee civil servants. Workshop 1 orients participants to the intervention with motivational interviewing techniques to improve engagement, teaches the difference between technical and adaptive challenges, and trains participants in a basic stress management strategy. Workshop 2 addresses a participant-selected problem using problem-solving techniques and introduces behavioral activation. Workshops 3 and 4 support participants' continued application of problem solving, behavioral activation, and stress management and introduce strategies to strengthen social support networks whenever required. In Workshop 5, education about retaining intervention gains are provided and all learned strategies are reviewed.
• Routine training induction sessions
The control group will receive 5 routine training induction sessions. These orientation sessions include lectures introduction to governance, public sector management, basic information technology, economics and public finance and official rules of procedure of the government of Pakistan. These lectures are held in a friendly and supportive environment.

Locations

Country	Name	City	State
Pakistan	Human Development Research Foundation	Islamabad

Sponsors (4)

Lead Sponsor	Collaborator
Human Development Research Foundation, Pakistan	Civil Services Academy (CSA), Lahore, Liverpool School of Tropical Medicine, University of Liverpool

Country where clinical trial is conducted

Pakistan, 

References & Publications (26)

Ahmad S, Hussain S, Shah FS, Akhtar F. Urdu translation and validation of GAD-7: A screening and rating tool for anxiety symptoms in primary health care. J Pak Med Assoc. 2017 Oct;67(10):1536-1540. — View Citation

Ahmer S, Faruqui RA, Aijaz A. Psychiatric rating scales in Urdu: a systematic review. BMC Psychiatry. 2007 Oct 26;7:59. Review. — View Citation

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Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. — View Citation

Chisholm D, Sweeny K, Sheehan P, Rasmussen B, Smit F, Cuijpers P, Saxena S. Scaling-up treatment of depression and anxiety: a global return on investment analysis. Lancet Psychiatry. 2016 May;3(5):415-24. doi: 10.1016/S2215-0366(16)30024-4. Epub 2016 Apr 12. — View Citation

Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. — View Citation

Goetzel RZ, Ozminkowski RJ, Sederer LI, Mark TL. The business case for quality mental health services: why employers should care about the mental health and well-being of their employees. J Occup Environ Med. 2002 Apr;44(4):320-30. Review. — View Citation

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Heifetz R, Grashow A, Linsky M.,2009. The Practice of Adaptive Leadership: Tools and Tactics for Change your Organization and the World. Boston, MA: Harvard Business Review Press.

Husain N, Gater R, Tomenson B, Creed F. Comparison of the Personal Health Questionnaire and the Self Reporting Questionnaire in rural Pakistan. J Pak Med Assoc. 2006 Aug;56(8):366-70. — View Citation

Jenkins R, Harvey S, Butler T, Thomas RL. Minor psychiatric morbidity, its prevalence and outcome in a cohort of civil servants--a seven-year follow-up study. Occup Med (Lond). 1996 Jun;46(3):209-15. — View Citation

Jenkins R. Sex differences in minor psychiatric morbidity. Psychol Med Monogr Suppl. 1985;7:1-53. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. — View Citation

Luthans, F., & Youssef, C. M. (2004). Human, social, and now positive psychological capital management: Investing in people for competitive advantage.

Luthans, F., Avolio, B. J., Avey, J. B., & Norman, S. M. (2007). Positive psychological capital: Measurement and relationship with performance and satisfaction. Personnel psychology, 60(3), 541-572.

Mirza I, Jenkins R. Risk factors, prevalence, and treatment of anxiety and depressive disorders in Pakistan: systematic review. BMJ. 2004 Apr 3;328(7443):794. Review. — View Citation

Patel V, Weiss HA, Chowdhary N, Naik S, Pednekar S, Chatterjee S, De Silva MJ, Bhat B, Araya R, King M, Simon G, Verdeli H, Kirkwood BR. Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial. Lancet. 2010 Dec 18;376(9758):2086-95. doi: 10.1016/S0140-6736(10)61508-5. Epub 2010 Dec 13. — View Citation

Rahman A, Hamdani SU, Awan NR, Bryant RA, Dawson KS, Khan MF, Azeemi MM, Akhtar P, Nazir H, Chiumento A, Sijbrandij M, Wang D, Farooq S, van Ommeren M. Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2609-2617. doi: 10.1001/jama.2016.17165. — View Citation

Rahman A, Malik A, Sikander S, Roberts C, Creed F. Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet. 2008 Sep 13;372(9642):902-9. doi: 10.1016/S0140-6736(08)61400-2. — View Citation

Rahman A, Riaz N, Dawson KS, Usman Hamdani S, Chiumento A, Sijbrandij M, Minhas F, Bryant RA, Saeed K, van Ommeren M, Farooq S. Problem Management Plus (PM+): pilot trial of a WHO transdiagnostic psychological intervention in conflict-affected Pakistan. World Psychiatry. 2016 Jun;15(2):182-3. doi: 10.1002/wps.20312. — View Citation

Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010 Mar 24;8:18. doi: 10.1186/1741-7015-8-18. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

Steel Z, Marnane C, Iranpour C, Chey T, Jackson JW, Patel V, Silove D. The global prevalence of common mental disorders: a systematic review and meta-analysis 1980-2013. Int J Epidemiol. 2014 Apr;43(2):476-93. doi: 10.1093/ije/dyu038. Epub 2014 Mar 19. Review. — View Citation

Topp CW, Østergaard SD, Søndergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28. Review. — View Citation

Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 9;382(9904):1575-86. doi: 10.1016/S0140-6736(13)61611-6. Epub 2013 Aug 29. Review. — View Citation

Whiteford HA, Ferrari AJ, Degenhardt L, Feigin V, Vos T. The global burden of mental, neurological and substance use disorders: an analysis from the Global Burden of Disease Study 2010. PLoS One. 2015 Feb 6;10(2):e0116820. doi: 10.1371/journal.pone.0116820. eCollection 2015. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Patient Health Questionnaire-9 (PHQ-9)	One of the primary outcomes is change in the prevalence of psychological distress as measured by PHQ-9 in the intervention arm as compared to the control arm. The 9-item Patient Health Questionnaire (PHQ-9), incorporates DSM-IV depression diagnostic criteria with other key major depressive symptoms (Kroenke et al, 2001). Participants rate their responses on a 4-point Likert scale ranging from not at all to nearly every day. The PHQ-9 total severity score ranges from 0 to 27. Higher score represents high psychological distress. The PHQ-9 has been validated in the Urdu language, showing adequate sensitivity and specificity (Husain et al 2006) and has been used in recent studies in KP (Rahman et al, 2016).	One of the primary end points is the prevalence of psychological distress at 3 months post intervention
Primary	Brief COPE	Another primary outcome is improvement in coping strategies measured by Brief COPE in the intervention arm as compared to the control arm. Brief COPE (Carver, 1997) is used to assess state coping (the way people cope with a specific stressful situation) and trait coping (the usual way people cope with stress in everyday life). It consists of 14 subscales i.e. active coping, planning, positive reframing, acceptance, humour, religion, use of emotional support, use of instrumental support, self-distraction, denial, venting, substance use, behavioral disengagement, and self-blame, with two items per sub-scale. The standard is to use sub-scale score. The score on each subscales ranges from 2 to 8. Higher score represents that person using the specific coping style a lot. Cronbach's alphas for the Brief COPE sub-scales range from 0.50 to 0.90 (Mayer, 2001).	Another primary end point is the improvement in coping strategies at 3 months post intervention
Secondary	Psychological Capital Questionnaire (PCQ)	Psychological capital will be measured using the Psychological Capital Questionnaire (PCQ) 12 items version (Avey et al, 2007). The PCQ-12 measures psychological capital across four domains (hope-4 items, optimism-2 items, resilience -3 items and self-efficacy-3 items). The participants rate their responses on 6 point likert scale. The total score ranges from 12-72. Higher scores represents higher psychological capital.	The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention
Secondary	Generalized Anxiety Disorder -7 scale (GAD-7)	GAD-7 will be used to measure anxiety (Spitzer et al, 2006) in the study sample. GAD-7 is based on the Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM IV) diagnostic criteria for generalised anxiety disorder, and has 7 items. Each item is scored on a likert scale from 0 to 3, generating a maximum score of 21. High score represents presence of anxiety symptoms.	The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention
Secondary	WHO-5 well-being index (WHO-5)	Well-being will be measured by WHO 5 Well-being index (Topp, et al, 2015). WHO-5 is a short and generic global rating scale measuring subjective well-being, the respondent is asked to rate how well each of the 5 statements applies to him or her when considering the last 14 days. The instrument will be administered to study participants at 3 months post intervention to rate their subjective well being in last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score ranges from 0 (absence of well-being) to 25 (maximal well-being). Scores are then converted to a percentage scale from 0 (absent) to 100 (maximal). Higher scores represent greater psychological well-being.	The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention