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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MRC/UVRI and LSHTM Uganda Research Unit

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, Uganda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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