search
Back to results

Problem Management Plus for Entrepreneurs

Primary Purpose

Well-being, Psychological Capital, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
PM+ for entrepreneurs
Cash transfer to the Entrepreneurs
Sponsored by
Human Development Research Foundation, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Well-being focused on measuring Well-being, Entrepreneurs, Conflict affected settings, Psychosocial intervention, Psychological Capital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-

Sites / Locations

  • Human Development Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PM+ for entrepreneurs

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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
Psychological Capital Questionnaire
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).
Multi-dimensional Scale for Perceived Social Support (MSPSS)
Social support will be measured using Multidimensional Scale for Perceived Social Support (MSPSS), adapted for use with this population. MSPSS measure perceived social support in three domains: family, friends and significant others (4 items each). Each item is rated on a seven-point Likert-scale (1 = very strongly disagree; 7 = very strongly agree). A total score is calculated by summing the results for all items (Akhtar et al, 2010; Zimet et al, 1988).
Individual Entrepreneurial Orientation (IEO)
Individual entrepreneurial behaviours will be measured using an adapted individual entrepreneurial orientation scale (Lee & Lim, 2009). Data will be collected on autonomy, innovativeness, risk taking, competitive aggressiveness, information seeking (proactive behaviour) and impulsiveness to reflect the degree of change in behaviours
Business behaviors
A specially designed questionnaire will be used to measure behaviours related to business planning.
Long term productivity
Long-term productivity will be measured using administrative data 12 months post the intervention. This would include data on key business metrics (sales, profits, employee turnover, amount of loans outstanding) as well as whether the firms are innovating or not.

Full Information

First Posted
April 14, 2018
Last Updated
August 2, 2022
Sponsor
Human Development Research Foundation, Pakistan
Collaborators
World Bank, University of Liverpool, Khyber Medical University Peshawar, Institute of Psychitry,WHO Collaborating Centre, Rawalpindi
search

1. Study Identification

Unique Protocol Identification Number
NCT03540927
Brief Title
Problem Management Plus for Entrepreneurs
Official Title
Impact of a Multicomponent Group Intervention on Psychosocial Well-being of Rehabilitated Entrepreneurs in a Conflict-affected Area of Pakistan: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Development Research Foundation, Pakistan
Collaborators
World Bank, University of Liverpool, Khyber Medical University Peshawar, Institute of Psychitry,WHO Collaborating Centre, Rawalpindi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Well-being, Psychological Capital, Anxiety, Depression
Keywords
Well-being, Entrepreneurs, Conflict affected settings, Psychosocial intervention, Psychological Capital

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Only outcome assessors will be blind to allocation status of the participants.
Allocation
Randomized
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PM+ for entrepreneurs
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control arm will receive a cash transfer only to support them in their businesses.
Intervention Type
Behavioral
Intervention Name(s)
PM+ for entrepreneurs
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cash transfer to the Entrepreneurs
Intervention Description
The entrepreneurs in the control arm will receive cash transfer only for their businesses.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
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 Outcome Measure Information:
Title
WHO-5 Well being index (WHO-5)
Description
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).
Time Frame
The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention
Title
GAD-7
Description
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
Time Frame
The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention
Title
Psychological Capital Questionnaire
Description
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).
Time Frame
The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention
Title
Multi-dimensional Scale for Perceived Social Support (MSPSS)
Description
Social support will be measured using Multidimensional Scale for Perceived Social Support (MSPSS), adapted for use with this population. MSPSS measure perceived social support in three domains: family, friends and significant others (4 items each). Each item is rated on a seven-point Likert-scale (1 = very strongly disagree; 7 = very strongly agree). A total score is calculated by summing the results for all items (Akhtar et al, 2010; Zimet et al, 1988).
Time Frame
The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention
Title
Individual Entrepreneurial Orientation (IEO)
Description
Individual entrepreneurial behaviours will be measured using an adapted individual entrepreneurial orientation scale (Lee & Lim, 2009). Data will be collected on autonomy, innovativeness, risk taking, competitive aggressiveness, information seeking (proactive behaviour) and impulsiveness to reflect the degree of change in behaviours
Time Frame
The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention
Title
Business behaviors
Description
A specially designed questionnaire will be used to measure behaviours related to business planning.
Time Frame
The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention
Title
Long term productivity
Description
Long-term productivity will be measured using administrative data 12 months post the intervention. This would include data on key business metrics (sales, profits, employee turnover, amount of loans outstanding) as well as whether the firms are innovating or not.
Time Frame
12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: -
Facility Information:
Facility Name
Human Development Research Foundation
City
Islamabad
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26664447
Citation
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.
Results Reference
background
PubMed Identifier
16967789
Citation
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.
Results Reference
background
PubMed Identifier
25742202
Citation
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.
Results Reference
background
PubMed Identifier
11556941
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. doi: 10.1046/j.1525-1497.2001.016009606.x.
Results Reference
background
PubMed Identifier
27837602
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.
Results Reference
background
PubMed Identifier
25831962
Citation
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.
Results Reference
background
PubMed Identifier
16717171
Citation
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.
Results Reference
background
PubMed Identifier
20666955
Citation
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.
Results Reference
background
Links:
URL
http://www.ilo.org/skills/pubs/WCMS_108152/lang--en/index.htm
Description
Mental health and work : impact, issues, and good practices
URL
http://link.springer.com/article/10.1007/s11628-008-0051-5
Description
Entrepreneurial orientation and the performance of service business

Learn more about this trial

Problem Management Plus for Entrepreneurs

We'll reach out to this number within 24 hrs