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

Primary Purpose

Ebola Virus Disease

Status
Recruiting
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Ebola+D intervention
Sponsored by
MRC/UVRI and LSHTM Uganda Research Unit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ebola Virus Disease focused on measuring Ebola associated psychological distress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mubende Regional Referal HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ebola+D intervention

Arm Description

Ebola+D intervention will include psycho-education, Problem Solving Therapy, antidepressant medication and referral to a supervising specialist mental health worker.

Outcomes

Primary Outcome Measures

Addressing the medium- to long-term EBOLA associated psychological Distress and psychosocial problems in Mubende District in central Uganda
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

Secondary Outcome Measures

Full Information

First Posted
August 7, 2023
Last Updated
October 19, 2023
Sponsor
MRC/UVRI and LSHTM Uganda Research Unit
Collaborators
Ministry of Health, Uganda
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1. Study Identification

Unique Protocol Identification Number
NCT06093646
Brief Title
Addressing Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Central Uganda
Acronym
Ebola+D
Official Title
Proposal to Address the Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Mubende District in Central Uganda (Ebola+D Project)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2023 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
August 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MRC/UVRI and LSHTM Uganda Research Unit
Collaborators
Ministry of Health, Uganda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ebola Virus Disease
Keywords
Ebola associated psychological distress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Screen participants attending 11 healthcare facilities at Mubende 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. The intervention will include psycho-education, Problem Solving Therapy, antidepressant medication and referral to a supervising specialist mental health worker. 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.
Masking
None (Open Label)
Masking Description
Masking will not be applied; eligible participants (with psychological distress) who consent to participate in this study will be offered the Ebola+D intervention
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ebola+D intervention
Arm Type
Experimental
Arm Description
Ebola+D intervention will include psycho-education, Problem Solving Therapy, antidepressant medication and referral to a supervising specialist mental health worker.
Intervention Type
Behavioral
Intervention Name(s)
Ebola+D intervention
Intervention Description
Ebola+D intervention will include psycho-education, Problem Solving Therapy, antidepressant medication and referral to a supervising specialist mental health worker.
Primary Outcome Measure Information:
Title
Addressing the medium- to long-term EBOLA associated psychological Distress and psychosocial problems in Mubende District in central Uganda
Description
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
Time Frame
Reduced psychological distress (SRQ-20 scores < 6) on two occasions ''4 weeks'' apart.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard S. Mpango, PhD
Phone
0772592504
Email
Richard.Mpango@mrcuganda.org
First Name & Middle Initial & Last Name or Official Title & Degree
Eugene Kinyanda, PhD
Phone
0788461950
Email
Eugene.Kinyanda@mrcuganda.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Kinyanda, PhD
Organizational Affiliation
MRC/UVRI and LSHTM Uganda Research unit, Uganda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mubende Regional Referal Hospital
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Mpango, PhD
Phone
+256773446556

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Addressing Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Central Uganda

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