Improving Psychological Well-being of Trainee Civil Servants in Pakistan

NCT03762421 | Completed

• 1 other identifier: 2018-CS PM+
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Psychological Capital Questionnaire (PCQ)

  The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention

• Generalized Anxiety Disorder -7 scale (GAD-7)

  The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention

• WHO-5 well-being index (WHO-5)

  The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention

Study Arms (2)

Psychosocial skills development workshops based on PM plus

EXPERIMENTAL

A number of psycho-social skills development workshops will be conducted for newly inducted civil servants, based on the problem management plus intervention. Problem Management Plus is a brief low-intensity, trans-diagnostic psychological intervention that helps with existing psychological problems as well as building resilience against future adversity. It addresses a range of psychological and practical problems that participants identify as relevant to their lives, including common mental health problems (WHO, 2016; Dawson, et al., 2015). The workshops will be integrated into the routine induction sessions for trainee civil servants.

Behavioral: Psycho-social skills development workshops based on PM plus

Control Arm

ACTIVE COMPARATOR

The control group will receive 5 routine training induction sessions.

Behavioral: Routine training induction sessions

Interventions

Psycho-social skills development workshops based on PM plus BEHAVIORAL

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.

Psychosocial skills development workshops based on PM plus

Routine training induction sessions BEHAVIORAL

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.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Human Development Research Foundation, Pakistan: lead
• University of Liverpool: collaborator
• Liverpool School of Tropical Medicine: collaborator
• Civil Services Academy (CSA), Lahore: collaborator

Study Sites (1)

Human Development Research Foundation

Islamabad, Pakistan

Location

Related 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.

  PMID: 28955070 BACKGROUND

• Ahmer S, Faruqui RA, Aijaz A. Psychiatric rating scales in Urdu: a systematic review. BMC Psychiatry. 2007 Oct 26;7:59. doi: 10.1186/1471-244X-7-59.

  PMID: 17963494 BACKGROUND

• Bolton P, Bass J, Neugebauer R, Verdeli H, Clougherty KF, Wickramaratne P, Speelman L, Ndogoni L, Weissman M. Group interpersonal psychotherapy for depression in rural Uganda: a randomized controlled trial. JAMA. 2003 Jun 18;289(23):3117-24. doi: 10.1001/jama.289.23.3117.

  PMID: 12813117 BACKGROUND

• 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. doi: 10.1207/s15327558ijbm0401_6.

  PMID: 16250744 BACKGROUND

• 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.

  PMID: 27083119 BACKGROUND

• 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. No abstract available.

  PMID: 26407793 BACKGROUND

• 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. doi: 10.1097/00043764-200204000-00012.

  PMID: 11977418 BACKGROUND

• 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.

  PMID: 16967789 BACKGROUND

• Jenkins R. Sex differences in minor psychiatric morbidity. Psychol Med Monogr Suppl. 1985;7:1-53. doi: 10.1017/s0264180100001788.

  PMID: 3875115 BACKGROUND

• 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. doi: 10.1093/occmed/46.3.209.

  PMID: 8695773 BACKGROUND

• 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. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• 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. doi: 10.1136/bmj.328.7443.794.

  PMID: 15070634 BACKGROUND

• 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.

  PMID: 21159375 BACKGROUND

• 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.

  PMID: 27837602 BACKGROUND

• 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.

  PMID: 18790313 BACKGROUND

• 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. No abstract available.

  PMID: 27265713 BACKGROUND

• 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.

  PMID: 20334633 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 24648481 BACKGROUND

• Topp CW, Ostergaard SD, Sondergaard 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.

  PMID: 25831962 BACKGROUND

• 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.

  PMID: 23993280 BACKGROUND

• 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.

  PMID: 25658103 BACKGROUND

• 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.

  BACKGROUND

• Harnois G, Gabriel P, World Health Organization., 2000. Mental health and work: impact, issues and good practices.

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Fidelity of masking will be ensured by having assessors guess the condition of each participant at the end of each assessment to assess the contamination across intervention and control arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 3, 2018
• Study Start: December 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: September 30, 2019
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)