Problem Management Plus for Entrepreneurs

NCT03540927 | Completed

• 1 other identifier: 2018-WB PM+
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

Conflict and unrest over three decades has resulted in significant economic decline in Khyber Pakhtunkhwa (KP) and Federally Administered Tribal Areas (FATA) of Pakistan and these now rank among the poorest regions in the country. The 2009-10 insurgency and subsequent security operations affected both regions and displaced an estimated 2 million people. The severe damage to infrastructure and livelihoods negatively impacted the social and economic fabric of the entire region. As peace has returned to the area, the Economic Revitalization of KP and FATA (ERKF) project, established in 2012 and supported by the World Bank, is working for the rehabilitation of small and medium enterprises (SMEs), with the aim of creation and restoration of jobs. This support is in the form of grants given to individuals who use the funds to establish and run a business in their locality. Epidemiological studies from the area have shown high rates of common mental disorder (eg., depression, anxiety) in the general population (Husain et al, 2006, Khan et al 2016). Such conditions have a serious impact on the well-being, functioning and productivity of affected individuals (World Health Organization, 2000). For example, in the USA, Depressive Disorders have been estimated to cost the economy over US$210 billion per annum, largely due to reduced productivity (Greenberg et al, 2015). The economic rehabilitation of a population exposed to a humanitarian crisis, and therefore at greater risk of depression, must include interventions to reduce mental morbidity so the individuals are able to function better and potentially improve their long-term productivity. The Human Development Research Foundation, in collaboration with the World Bank, has adapted a 5-session group intervention from WHO Problem Management Plus program, tailored to the needs of small and medium enterprise owners affected by the prolonged conflict in KP and FATA areas of Pakistan. This intervention (Problem Management Plus adapted for entrepreneurs) is based on established cognitive behavioral strategies previously tested in Pakistan (Rahman et al, 2016). The goal of the intervention is to improve psychological capital,reduce psychosocial distress leading to, increased productivity in the long-term. The intervention will be evaluated using a two arm, single blind randomized controlled trial.

Conditions

Well-being; Psychological Capital; Anxiety; Depression

Keywords

Well-being; Entrepreneurs; Conflict affected settings; Psychosocial intervention; Psychological Capital

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ-9)

  The primary outcome 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. 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).

  Primary end point is percentage change in the prevalence of psychological distress in the intervention arm as compared to the control arm at 3 months post intervention.

Secondary Outcomes (7)

• 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

• GAD-7

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

• Psychological Capital Questionnaire

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

• Multi-dimensional Scale for Perceived Social Support (MSPSS)

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

• Individual Entrepreneurial Orientation (IEO)

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

Study Arms (2)

PM+ for entrepreneurs

EXPERIMENTAL

The intervention arm participants will receive a cash transfer to support them in their businesses PLUS 5 weekly face-to-face group sessions of Problem Management Plus(PM+ for entrepreneurs). Duration of each session is 2 hours. Session 1 orients participants to the intervention with motivational interviewing techniques to improve engagement, provides information about common reactions to adversity, and trains participants in a basic stress management strategy (slow breathing). Session 2 discusses problem solving technique.Sessions 3 and 4 support participants' continued application of problem solving, behavioral activation, and stress management and introduce strategies to strengthen social support networks. In session 5, education about retaining intervention gains and self-care are provided and all learned strategies are reviewed.

Behavioral: PM+ for entrepreneurs; Other: Cash transfer to the Entrepreneurs

Control

ACTIVE COMPARATOR

The control arm will receive a cash transfer only to support them in their businesses.

Other: Cash transfer to the Entrepreneurs

Interventions

PM+ for entrepreneurs BEHAVIORAL

The intervention arm will receive 5 weekly face-to-face group sessions of Problem Management Plus(PM+ for entrepreneurs). Duration of each session is 2 hours. Session 1 orients participants to the intervention with motivational interviewing techniques to improve engagement,provides information about common reactions to adversity, and trains participants in a basic stress management strategy (slow breathing). Session 2 addresses a participant-selected problem using problem-solving techniques. Sessions 3 and 4 support participants' continued application of problem solving, behavioral activation, and stress management and introduce strategies to strengthen social support networks. In session 5, education about retaining intervention gains and self-care are provided and all learned strategies are reviewed.

PM+ for entrepreneurs

Cash transfer to the Entrepreneurs OTHER

The entrepreneurs in the control arm will receive cash transfer only for their businesses.

Control; PM+ for entrepreneurs

Eligibility Criteria

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

You may qualify if:

• All small and medium entrepreneurs, leading SMEs and family businesses in situations of fragility encountered in KP/FATA, Pakistan, who received a cash transfer for rehabilitation of their businesses by Economic Revitalization of Khyber Pakhtunkhwa and FATA (ERKF), Pakistan.

Sponsors & Collaborators

• Human Development Research Foundation, Pakistan: lead
• World Bank: collaborator
• University of Liverpool: collaborator
• Khyber Medical University Peshawar: collaborator
• Institute of Psychitry,WHO Collaborating Centre, Rawalpindi: collaborator

Study Sites (1)

Human Development Research Foundation

Islamabad, Pakistan

Location

Related Publications (8)

• Khan MN, Chiumento A, Dherani M, Bristow K, Sikander S, Rahman A. Psychological distress and its associations with past events in pregnant women affected by armed conflict in Swat, Pakistan: a cross sectional study. Confl Health. 2015 Dec 10;9:37. doi: 10.1186/s13031-015-0063-4. eCollection 2015.

  PMID: 26664447 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

• Greenberg PE, Fournier AA, Sisitsky T, Pike CT, Kessler RC. The economic burden of adults with major depressive disorder in the United States (2005 and 2010). J Clin Psychiatry. 2015 Feb;76(2):155-62. doi: 10.4088/JCP.14m09298.

  PMID: 25742202 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

• 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

• 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

• 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

• Akhtar A, Rahman A, Husain M, Chaudhry IB, Duddu V, Husain N. Multidimensional scale of perceived social support: psychometric properties in a South Asian population. J Obstet Gynaecol Res. 2010 Aug;36(4):845-51. doi: 10.1111/j.1447-0756.2010.01204.x.

  PMID: 20666955 BACKGROUND

Related Links

• Mental health and work : impact, issues, and good practices
• Entrepreneurial orientation and the performance of service business

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only outcome assessors will be blind to allocation status of the participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2018
• First Posted: May 30, 2018
• Study Start: June 20, 2018
• Primary Completion: February 28, 2019
• Study Completion: June 30, 2019
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)