Problem Management Plus for Entrepreneurs

Study Overview
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Brief Summary
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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.

Official Title
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Impact of a Multicomponent Group Intervention on Psychosocial Well-being of Rehabilitated Entrepreneurs in a Conflict-affected Area of Pakistan: A Randomised Controlled Trial

Conditions
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Well-being, Psychological Capital, Anxiety, Depression

Intervention / Treatment
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* Behavioral: PM+ for entrepreneurs
* Other: Cash transfer to the Entrepreneurs


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PM+ for entrepreneurs<br>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<br>* 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.<br>Other: Cash transfer to the Entrepreneurs<br>* The entrepreneurs in the control arm will receive cash transfer only for their businesses.<br>|
| Active Comparator: Control<br>The control arm will receive a cash transfer only to support them in their businesses. | Other: Cash transfer to the Entrepreneurs<br>* The entrepreneurs in the control arm will receive cash transfer only for their businesses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention | 
| 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 | The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention | 
| 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). | 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) | 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). | The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention | 
| 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 | The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention | 
| Business behaviors | A specially designed questionnaire will be used to measure behaviours related to business planning. | The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention | 
| 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. | 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Conflict affected settings, Psychosocial intervention, Psychological Capital, Well-being, Entrepreneurs