Mental Health in Communities Affected by COVID-19 in Uganda

NCT04616989 | Completed DMC

• 1 other identifier: Integration of mental health
• Study Type: interventional
• Target: 814
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: During pandemics like the COVID-19, a significant number of the populace suffer from psychological distress (PD) that often abates naturally over time in the majority of people but persists in others to become pervasive and severe enough to trigger the onset of common mental disorders (CMD) like major depressive disorders (MDD), generalized anxiety disorders (GAD), post-traumatic stress disorders (PTSD) and substance misuse disorders (SUD). Once identified, psychological distress as well as CMD can be managed using psychotherapy or pharmacotherapy. However, low levels of mental health literacy (MHL) manifested by the individual's unawareness of CMD symptoms, limited human and mental health infrastructure resources and high levels of mental illness stigma (MIS), are barriers to integration of mental health care in general health care during pandemics and epidemics such as the COVID-19. The study objectives will include: (a) Documenting MHL, PD, MDD, GAD, PTSD and SUD levels in the study population, (b) Determining the effectiveness of a psycho-education intervention delivered by village health team (VHT) members on study outcomes Methods: We shall employ an open label cluster-randomized trial design, with each village as a cluster, to conduct the study in 24 villages (12 intervention and 12 control villages) in Kampala (n= 15), Wakiso (n= 3), Masaka (n= 2) and Mukono (n= 4) districts. To ensure balance between the two study arms, villages underwent stratified randomization on the basis of rural vs urban population. The second level of stratification will be achieved by a separate randomization procedure performed within each stratum to ensure gender balance within each cluster We will develop information education and communication materials (IEC) aimed at improving MHL and reducing MIS. In the intervention arm (n=12 villages), VHTs will distribute the IEC materials in every 12th household till they accrue 420 individuals (adults ≥ 18 years old) who express interest in participating in the study. In the control arm (n=12 villages), VHTs will distribute MOH COVID-19 information leaflets in every 12th household till they accrue 420 individuals who express interest in participating in the study. Within 7days after distribution of the materials, trained research assistants will schedule and assess participants (through a phone interview) for MHL, PD, MDD, GAD, PTSD and SUD. Individuals who don't have phones will be asked to provide a phone number of a friend or relative through which the interviews can be conducted; interviews could also be conducted using the VHTs' phone. Cost data will be collected using available implementation data. We will document the number of individuals from both arms who will contact the investigators Data analysis plans: We will (a) report frequencies and percentages and their 95% confidence intervals for the first objective, (b) use an intention to treat analysis to analyze the second objective, Conclusion: Findings from this research will guide policy and practice regarding the integration of mental health services in the community in the context of epidemic preparedness and response.

Conditions

Community Mental Health

Outcome Measures

Primary Outcomes (1)

• Change in mental health literacy

  We will document the change in the mean scores of mental health literacy between the two arms measured using the Mental health Knowledge Schedule (MAKS) instrument

  2 months

Secondary Outcomes (4)

• Burden of anxiety disorders in the community

  2 months

• Burden of PTSD in the community

  2 months

• Burden of substance use disorders in the community

  2 months

• Burden of depression disorders in the community

  2 months

Study Arms (2)

Psycho-education intervention arm

EXPERIMENTAL

Participants will receive psycho-education materials

Behavioral: Psycho-education

Comparator arm

ACTIVE COMPARATOR

Participants will receive COVID-19 leaflets

Behavioral: Comparator

Interventions

Psycho-education BEHAVIORAL

Provide psycho-education to members of the community

Psycho-education intervention arm

Comparator BEHAVIORAL

Distribution of COVID-19 leaflets to members of the community

Comparator arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and above who live in the community where data will be collected

You may not qualify if:

• Individuals with acute illnesses that will prevent them from providing information during data collection

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Dickens Akena

Kampala, Uganda

Location

Related Publications (1)

• Akena D, Kiguba R, Muhwezi WW, Kwesiga B, Kigozi G, Nakasujja N, Lukwata H. The effectiveness of a psycho-education intervention on mental health literacy in communities affected by the COVID-19 pandemic-a cluster randomized trial of 24 villages in central Uganda-a research protocol. Trials. 2021 Jul 13;22(1):446. doi: 10.1186/s13063-021-05391-6.

  PMID: 34256810 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants in the intervention arm will receive leaflets about the mental health literacy while those in the control arm will receive COVID-19 leaflets

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: November 5, 2020
• Study Start: November 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)