NCT04777006 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M
Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.
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.
McBain RK, Salhi C, Hann K, Kellie J, Kamara A, Salomon JA, Kim JJ, Betancourt TS
Improving outcomes for caregivers through treatment of young people affected by war: a randomized controlled trial in Sierra Leone. Bull World Health Organ. 2015 Dec 1;93(12):834-41. doi: 10.2471/BLT.14.139105. Epub 2015 Oct 16.
Passchier RV, Abas MA, Ebuenyi ID, Pariante CM
Effectiveness of depression interventions for people living with HIV in Sub-Saharan Africa: A systematic review & meta-analysis of psychological & immunological outcomes. Brain Behav Immun. 2018 Oct;73:261-273. doi: 10.1016/j.bbi.2018.05.010. Epub 2018 May 13.
Udedi M
The prevalence of depression among patients and its detection by primary health care workers at Matawale Health Centre (Zomba). Malawi Med J. 2014 Jun;26(2):34-7.
World Economic Forum
The Global Economic Burden of Non-Communicable Diseases. World Economic Forum; Harvard School of Public Health; 2011.

Integrating a Stepped Care Model of Screening and Treatment for Depression Into Malawi's National HIV Care Delivery Platform

Clinical trial NCT04777006 - References