Addressing Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Central Uganda (Ebola+D)

October 19, 2023 updated by: MRC/UVRI and LSHTM Uganda Research Unit

Proposal to Address the Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Mubende District in Central Uganda (Ebola+D Project)

Screen participants attending 11 healthcare facilities in Mubende District for psychological distress using the locally validated Luganda or English version of the WHO- Self Report Questionnaire (SRQ-20). Those individuals found to have significant psychological distress (a score of 6 and above) will be offered Ebola+D intervention [a stepped care collaborative delivery model to address the medium- to long-term EBOLA associated psychological Distress and psychosocial problems] . A cohort of Ebola Virus Disease (EVD) affected individuals accessing the Ebola +D mental health intervention will be recruited and followed up for 12 months with assessments at three time points; baseline, 3 months and 12 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ebola Virus Disease (EVD) is associated with high mortality, physical morbidity among patients and survivors, plus being associated with significant mental health and psychosocial problems among patients/survivors, their family members, members of the affected communities, health workers and volunteers. To support the medical services of Mubende district cope with the Ebola associated mental health and psychosocial problems, the Ministry of Health of Uganda has partnered with the MRC/UVRI & LSHTM Uganda Research Unit to implement a health systems strengthening project in the district entitled, 'Addressing the medium to long-term EBOLA associated psychological Distress and psychosocial problems in Mubende District in central Uganda (Ebola+D Project)'.

Methodology: The project will be undertaken in the 11 selected health care facilities in Mubende district. Members of the community attending these selected health care facilities will be screened for psychological distress using the locally validated Luganda or English version of the WHO- Self Report Questionnaire (SRQ-20). Those individuals found to have significant psychological distress (a score of 6 and above) will be offered Ebola+D intervention. A cohort of EVD affected individuals accessing the Ebola +D mental health intervention will be recruited and followed up for 12 months with assessments at three time points; baseline, 3 months and 12 months.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Uganda
      • Kampala, Uganda
        • Recruiting
        • Mubende Regional Referal Hospital
        • Contact:
          • Richard Mpango, PhD
          • Phone Number: +256773446556

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Community member of Mubende district staying within the catchment area of the primary health care facility (PHCF);
  • 18years and above,
  • Able to communicate in either English or Luganda (local language spoken in the study region and the language into which the questionnaires will be translated),
  • Has a WHO SRQ-20 score of 6 and above (except for Ebola survivors who are eligible even when their SRQ-20 score is either below or above 6). -

Exclusion Criteria:

  • Unable to engage with the research process for any reason that may include sensory impairment or cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ebola+D intervention
Ebola+D intervention will include psycho-education, Problem Solving Therapy, antidepressant medication and referral to a supervising specialist mental health worker.
Behavioral: Ebola+D intervention
Ebola+D intervention will include psycho-education, Problem Solving Therapy, antidepressant medication and referral to a supervising specialist mental health worker.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Addressing the medium- to long-term EBOLA associated psychological Distress and psychosocial problems in Mubende District in central Uganda
Time Frame: Reduced psychological distress (SRQ-20 scores < 6) on two occasions ''4 weeks'' apart.
Remission at ''3 months'' after completion of prescribed mental health treatment step(s) reduced psychological distress (SRQ-20 scores < 6) on two occasions ''4 weeks'' apart
Reduced psychological distress (SRQ-20 scores < 6) on two occasions ''4 weeks'' apart.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MRC/UVRI and LSHTM Uganda Research Unit

Collaborators

Ministry of Health, Uganda

Investigators

  • Principal Investigator: Eugene Kinyanda, PhD, MRC/UVRI and LSHTM Uganda Research unit, Uganda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2023

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

August 15, 2024

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGEK230305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data collected from participants will be widely shared to support other research in the future, and may be shared anonymously with other researchers/authorities to effect policies /programs

IPD Sharing Time Frame

After the study (August 2024

IPD Sharing Access Criteria

Data sets

IPD Sharing Supporting Information Type

  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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