Ebola Virus DiseaseEbola+DNCT06093646
Addressing Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Central Uganda
A study testing Ebola+D intervention in people with Ebola Virus Disease, run by MRC/UVRI and LSHTM Uganda Research Unit at 1 site in Uganda.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- Ebola+D intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUganda
- Study dates
- 22 Sep 2023to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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). -
Who cannot join
- Unable to engage with the research process for any reason that may include sensory impairment or cognitive impairment
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Mubende Regional Referal Hospital
Kampala
Richard Mpango, PhD, +256773446556
About this study
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)
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.
Read the 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.
- Conditions
- Ebola Virus Disease
- Being tested
- Ebola+D intervention
- Keywords
- Ebola associated psychological distress
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ebola+D interventionBehavioural
Ebola+D intervention will include psycho-education, Problem Solving Therapy, antidepressant medication and referral to a supervising specialist mental health worker.
| Study group | Role | What they receive |
|---|---|---|
| Ebola+D intervention | Experimental | Ebola+D intervention will include psycho-education, Problem Solving Therapy, antidepressant medication and referral to a supervising specialist mental health worker. Receives: Behavioral: Ebola+D intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Reduced psychological distress (SRQ-20 scores < 6) on two occasions ''4 weeks'' apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start22 Sep 2023
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Uganda
- Responsible party
- Sponsor
- Investigators
- Eugene Kinyanda, PhD, Principal investigator, MRC/UVRI and LSHTM Uganda Research unit, Uganda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093646
- Sponsor's protocol ID
- RGEK230305
- Acronym
- Ebola+D
- Status last verified
- Oct 2023
- First submitted
- 7 Aug 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Kyohangirwe L, Mpango RS, Tusiime C, Rutakumwa R, Ssebunnya J, Obuku A, Kiconco BE, Sekitoleko I, Sentongo H, Kalani K, Muhwezi W, Greco G, Baltra RA, Knizek BL, Kaleebu P, Mondelli V, Kyegombe N, Tenywa P, Amanyire P, Ssembajjwe W, Lund C, Kinyanda E. Protocol to develop and pilot a primary mental healthcare intervention model to address the medium- to long-term Ebola associated psychological distress and psychosocial problems in Mubende District in Central Uganda (the Ebola+D project). PLoS One. 2025 Aug 6;20(8):e0329591. doi: 10.1371/journal.pone.0329591. eCollection 2025.
PubMed 40768507
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06093646
- Acronym / sponsor ID
- Ebola+D / RGEK230305
- Conditions
- Ebola Virus Disease
- Keywords
- Ebola associated psychological distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research UnitUniversity, hospital or other
- Collaborators
- Ministry of Health, Uganda
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ebola+D intervention | Experimental | Behavioral: Ebola+D interventionEbola+D intervention will include psycho-education, Problem Solving Therapy, antidepressant medication and referral to a supervising specialist mental health worker. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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). -
Key exclusion criteria (1 listed)
- Unable to engage with the research process for any reason that may include sensory impairment or cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ebola+D interventionEbola+D intervention will include psycho-education, Problem Solving Therapy, antidepressant medication and referral to a supervising specialist mental health worker. | Behavioural | Ebola+D intervention |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 40768507Kyohangirwe L, Mpango RS, Tusiime C, Rutakumwa R, Ssebunnya J, Obuku A, Kiconco BE, Sekitoleko I, Sentongo H, Kalani K, Muhwezi W, Greco G, Baltra RA, Knizek BL, Kaleebu P, Mondelli V, Kyegombe N, Tenywa P, Amanyire P, Ssembajjwe W, Lund C, Kinyanda E. Protocol to develop and pilot a primary mental healthcare intervention model to address the medium- to long-term Ebola associated psychological distress and psychosocial problems in Mubende District in Central Uganda (the Ebola+D project). PLoS One. 2025 Aug 6;20(8):e0329591. doi: 10.1371/journal.pone.0329591. eCollection 2025.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Kinyanda, PhD principal investigator
MRC/UVRI and LSHTM Uganda Research unit, Uganda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ebola+D intervention in people with Ebola Virus Disease, run by MRC/UVRI and LSHTM Uganda Research Unit at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard S. Mpango, PhD (0772592504, Richard.Mpango@mrcuganda.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06093646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.