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

Sponsor

MRC/UVRI and LSHTM Uganda Research Unit (Other)

Overall Status

Recruiting

CT.gov ID

NCT06093646

Collaborator

Ministry of Health, Uganda (Other)

1,000

Enrollment

Location

Arm

10.8

Anticipated Duration (Months)

92.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ebola Virus Disease	Behavioral: Ebola+D intervention	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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

Primary Purpose:

Supportive Care

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)

Actual Study Start Date :

Sep 22, 2023

Anticipated Primary Completion Date :

Jun 15, 2024

Anticipated Study Completion Date :

Aug 15, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mubende Regional Referal Hospital	Kampala		Uganda

Sponsors and Collaborators

MRC/UVRI and LSHTM Uganda Research Unit
Ministry of Health, Uganda

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

MRC/UVRI and LSHTM Uganda Research Unit

ClinicalTrials.gov Identifier:

NCT06093646

Other Study ID Numbers:

RGEK230305

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by MRC/UVRI and LSHTM Uganda Research Unit

Ebola associated psychological distress

Additional relevant MeSH terms:

Virus Diseases

Hemorrhagic Fever, Ebola

Study Results

No Results Posted as of Oct 23, 2023