Problem Management Plus for Entrepreneurs

NCT03540927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2022-08-03

No results posted yet for this study

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

Interventions

BEHAVIORAL

PM+ for entrepreneurs

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.

OTHER

Cash transfer to the Entrepreneurs

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

Sponsors & Collaborators

  • World Bank

    collaborator OTHER
  • University of Liverpool

    collaborator OTHER
  • Khyber Medical University Peshawar

    collaborator OTHER
  • Institute of Psychitry,WHO Collaborating Centre, Rawalpindi

    collaborator UNKNOWN
  • Human Development Research Foundation, Pakistan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-20
Primary Completion
2019-02-28
Completion
2019-06-30

Countries

  • Pakistan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03540927 on ClinicalTrials.gov