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AzTrials

Psychological DistressNCT03762421

Improving Psychological Well-being of Trainee Civil Servants in Pakistan

A study testing Psycho-social skills development workshops based on PM plus and Routine training induction sessions in people with Psychological Distress and Coping Skills, run by Human Development Research Foundation, Pakistan at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Psychological Distress, Coping Skills, Well-being
What is being tested?
Psycho-social skills development workshops based on PM plus and Routine training induction sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 sitePakistan
Study dates
1 Dec 2018to 30 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Human Development Research Foundation

    Islamabad

Other trials in Pakistan

About this study

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

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).

Read more

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.

Being tested
Psycho-social skills development workshops based on PM plus, Routine training induction sessions
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psycho-social skills development workshops based on PM plusBehavioural

    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 sessionsBehavioural

    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.

Study groups in NCT03762421
Study groupRoleWhat they receive
Psychosocial skills development workshops based on PM plusExperimentalA 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.
Receives: Behavioral: Psycho-social skills development workshops based on PM plus
Control ArmActive comparatorThe control group will receive 5 routine training induction sessions.
Receives: Behavioral: Routine training induction sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: One of the primary end points is the prevalence of psychological distress at 3 months post intervention

  2. 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).

    Measured: Another primary end point is the improvement in coping strategies at 3 months post intervention

Secondary outcomes (3)

  1. 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.

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

  2. 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.

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

  3. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2018
  2. Study start1 Dec 2018
  3. Primary completion31 Jul 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03762421
Sponsor's protocol ID
2018-CS PM+
Status last verified
Aug 2022
First submitted
30 Nov 2018
Last updated
4 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28955070

  • 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.

    PubMed 17963494

  • 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.

    PubMed 12813117

  • 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.

    PubMed 16250744

  • 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.

    PubMed 27083119

  • 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.

    PubMed 26407793

  • 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.

    PubMed 11977418

  • 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.

    PubMed 16967789

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

    PubMed 3875115

  • 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.

    PubMed 8695773

  • 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.

    PubMed 11556941

  • 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.

    PubMed 15070634

  • 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.

    PubMed 21159375

  • 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.

    PubMed 27837602

  • 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.

    PubMed 18790313

Questions about this trial

What is this clinical trial studying?

A study testing Psycho-social skills development workshops based on PM plus and Routine training induction sessions in people with Psychological Distress and Coping Skills, run by Human Development Research Foundation, Pakistan at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Patient Health Questionnaire-9 (PHQ-9) (time frame: One of the primary end points is the prevalence of psychological distress at 3 months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03762421, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.

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