Clinical trial NCT06093646: Addressing Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Central Uganda
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
Overall status: RECRUITING
Phase: NA
Conditions: Ebola Virus Disease
Keywords: Ebola associated psychological distress
Lead sponsor: MRC/UVRI and LSHTM Uganda Research Unit
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Uganda
First posted: 2023-10-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Addressing the medium- to long-term EBOLA associated psychological Distress and psychosocial problems in Mubende District in central Uganda
timeFrame: Reduced psychological distress (SRQ-20 scores < 6) on two occasions ''4 weeks'' apart.
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mubende Regional Referal Hospital
Study officials:
affiliation: MRC/UVRI and LSHTM Uganda Research unit, Uganda
name: Eugene Kinyanda, PhD
role: PRINCIPAL_INVESTIGATOR
References: