NCT03540927

Problem Management Plus for Entrepreneurs

Completed NA Last updated 3 August 2022

What this trial tests

NA trial testing PM+ for entrepreneurs in Well-being in 235 participants. Completed in 30 June 2019.

Timeline

20 June 2018

Primary endpoint
28 February 2019

30 June 2019

Quick facts

Lead sponsor	Human Development Research Foundation, Pakistan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	235
Start date	20 June 2018
Primary completion	28 February 2019
Estimated completion	30 June 2019
Sites	1 location across Pakistan

Drugs / interventions tested

• PM+ for entrepreneurs
• Cash transfer to the Entrepreneurs

Conditions studied

• Well-being — all drugs for Well-being →
• Psychological Capital — all drugs for Psychological Capital →
• Anxiety — all drugs for Anxiety →
• Depression — all drugs for Depression →

Sponsor

Human Development Research Foundation, Pakistan

Who can join

18 and older, any sex, with Well-being or Psychological Capital. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.