Mental Health in Communities Affected by COVID-19 in Uganda
Mental Health in Communities Affected by COVID-19 in Uganda
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.
Study design: The investigators will use a multi-stage open-label cluster-randomized trial of
 24 randomly chosen villages (n=12 intervention and n=12 control) in Kampala (n=15), Wakiso
 (n=3), Mukono (n=4) and Masaka (n=2) districts. Intervention and control villages are at
 least 20km apart to avoid contamination

 Study procedure:

 (i) Randomization and sampling: The investigators 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

 The investigators shall employ the multistage open label sampling approach to select 840
 participants from 24 randomly selected villages located in the 362 parishes (5250 villages)
 that span the study districts. Study villages will be selected using the probability
 proportional to size approach (based on number of parishes/villages per district). Thus, the
 investigators shall select 15 villages from Kampala district (3297 villages), 4 villages from
 Mukono district (813 villages), 2 villages from Masaka district (436 villages) and 3 villages
 from Wakiso district (704 villages). The villages are at least 20km apart to avoid
 contamination (individuals interacting during the intervention).

 (ii) Participant identification: The investigators shall engage the VHT and village Local
 Chairpersons to distribute leaflets describing the study to every 12th household in their
 catchment area till they accrue 38 participants in their village who express interest in
 participating in the study. This figure is based on an average of 4710 households per
 village. Thus 4710/38 is approximately every 12th household. Individuals who express interest
 in the study will be given 2 consent forms which they will read and sign should they decide
 to participate; they will retain one copy. VHTs will read out the consent form to individuals
 who can neither read nor write and obtain informed consent (participants will use their thumb
 print soaked in an inkpad to consent). Consent forms will be translated into Luganda. The VHT
 will then get the participant's telephone contact and provide it to the project administrator
 who will pass them to research assistants. 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 if the participants comfortable
 receiving calls on the VHT's telephone. The VHT will inform the project administrator of
 participants without personal phones and indicate how that participant can be contacted. The
 investigators will conduct a times and motions assessment to document the duration of the
 interventions as well as the amount of money spent on transport refunds for the VHTs and the
 airtime costs

 (iii) Baseline data collection: Trained research assistants will call participants and
 schedule a phone interview and collect demographic (age, gender, education level and place of
 residence) information and administer the Mental health Knowledge Schedule (MAKS) to assess
 for MHL, Kesler-10 (K-10) to measure PD, the Generalized Anxiety Disorder scale (GAD-7) to
 assess for GAD, Patient Health Questionnaire-9 (PHQ-9) to assess for MDD Post-Traumatic
 Stress Disorder- Primary Care Screen (PTSD-PC) for PTSD and the Alcohol Smoking and Substance
 Involvement screening Test (ASSIST) to assess for SUD.

 (iv) The intervention: Within a week of the baseline surveys, VHTs in the 12 intervention
 villages described above- (a) basic information about the symptoms of PD (b) their adverse
 effects, (c) the signs and symptoms of CMD, (d) the benefits associated with having them
 treated and (e) the contact details of the research team should they need more information.
 See a template of the IEC materials attached. Previous studies have administered the
 post-test questionnaires a week after the baseline assessment .

 In the 12 control villages, VHTs will distribute the MOH IEC materials that contain
 information about (a) the signs and symptoms of the COVID-19 and the preventive measures, (b)
 the fact that individuals may suffer from PD during the pandemic (c) the sources from where
 they can get psychosocial help and (d) the contact details of the research team should they
 need more information. The IEC materials will be distributed to individuals who participated
 in the baseline surveys

 Mitigating the possibility of contamination between the study arms: Being an educational
 intervention, there is a chance that participants in the control villages will access IEC
 materials distributed to those in the intervention arm, leading to contamination of the study
 findings. To avoid contamination, the investigators will do the following: (i) randomize
 villages so that they are at least 20km apart (with the limited human movements during the
 COVID-19 pandemic, we anticipate that there will be little by way of people sharing the IEC
 materials), (ii) conduct the assessments within a week of distributing the materials to limit
 the chances that the information will be widely circulated, (iii) ask participants in the
 control arms if they accessed the IEC materials meant for the control group.

 (v) Follow-up data collection: Within a week after the VHTs have distributed IEC materials,
 research assistants will call participants from both arms and (i) confirm whether they
 received IEC materials (and read it), then (ii) schedule a phone interview to administer the
 instruments administered at baseline (MAKS, K-10, GAD-7, PHQ-9, PTSD-PC and ASSIST).

 Study measures: Research assistants will administer standardized questionnaires to collect:
 i) Demographic variables including age, gender, physical address, contact information,
 marital and employment status, education level ii) primary study variable (MHL using MAKS)
 and (iii) secondary variables including PD using the K-10, GAD using the GAD-7, MDD using the
 PHQ-9, PTSD using the PTSD-PC and SUD using the ASSIST.

 Participant Follow-up: Participants will be assessed for the outcomes of interest at baseline
 and within a week (7 days). Participants who have been referred to the psychosocial teams
 will be called after 14 days to find out whether they followed up on the referral and if not,
 state the reasons for not doing so.

 Adverse event reporting during the interviews: The investigators anticipate that there will
 be minimal adverse events that are directly related to the study, mainly psychological
 distress resulting from answering the questions during the survey or loss of private data.
 However, in the event that the investigators realize any severe form of distress, or loss of
 privacy/confidentiality, then the investigators will report it promptly reported to the
 SOMREC/UNCST.

 Community tracing: In the event that a participant cannot be accessed for the second
 interview after the baseline one, then, the investigators will ask the VHT to visit the
 physical location and find out the reason for non-response. The VHT will be provided with a
 Log to record this kind of information which could be loss of a phone, change in phone number
 of withdrawal from the study among other reasons. If the participant can't be contacted on
 phone and physically, (may have moved house), then the investigators will consider this a
 loss to follow up.

 Sample size and statistical considerations Hypothesis: The investigators hypothesize that (a)
 the MHL levels are low in the communities in comparison to those observed in high income
 countries, (b) a psycho-education intervention delivered by VHTs will lead to a 50% increase
 in MHL levels in the intervention arm compared to the control arm (that this difference will
 be clinically significant), (c) more participants in the intervention arm will contact the
 study team compared to the control arm - and that this difference will be clinically
 significant

 1. Sample size for objective 1. To document the baseline community MHL level, the
 investigators will use the Leslie-Kish formular for calculating the sample size for
 cross sectional studies. The formula states that: n = Z2 p (1-p)/E2. n- sample size,
 E-The standard error (5%), p- Proportion of patients; 50%.The prevalence was estimated
 at 50% as the conservative estimates for outcomes or effects sizes with limited
 literature to refer to (in this case, prevalence of poor MHL in the Ugandan community).
 Z- The standard normal deviation of 1.96 corresponding to 95% confidence interval
 Substituting; n=1.962 X 0.5 X (1-0.5)/0.052 n= 384. b) For the population survey, the
 investigators will use the sample size calculation, but use a community correction
 effect of 2. Thus the sample size for the community sample will be 384X2 = 764. The
 investigators will add a 10% sample size to cater for incomplete data mainly due to
 failure to complete an interview. Thus, the total sample size will be 840 participants
 (420 in the control and 420 in the intervention arms).

 2. Sample size for objective 2: To determine the effectiveness of the psycho-education
 intervention, the investigators have calculated the size of effects that the sample will
 be able to detect a clinically significant difference in MHL level between the
 intervention and control arms. The nature of the educational intervention makes
 randomization by clusters (villages) more appropriate in comparison to randomization by
 individuals or household.

 To estimate the number of villages required per arm for a clinically significant effect size
 of 50%: The investigators assume power of 80% at the 95% confidence level, mean MHL score of
 14.14 and standard deviation (SD) of 2.19, cluster-size of 35 participants and coefficient of
 variation of 0.25, which yields ~8 villages per trial-arm. The investigators shall include a
 minimum of 12 villages per arm (50% increment) to cater for the following limitations; i) the
 large proportion of participants who do not own mobile phones (~30%) (Incomplete data due to
 participants not being able to complete interviews). Therefore, 24 villages (both arms) will
 be required; thus, including up to 840 participants (420 per trial-arm).

 Data collection and management: Data will be collected on paper and then entered into a
 centralized, web-based data management scheme using the open source software REDCap™.

 Statistical Analysis

 Objective 1: The investigators will report frequencies and percentages of the study outcomes
 and their 95% confidence intervals.

 Objective 2: An intention-to-treat analysis will be conducted to compare the groups at
 baseline and within 4 weeks to assess the effects of the intervention on MHL. The dependent
 variable (MHL) will be calculated as a continuous variable. Independent variables including
 presence of PD, MDD, GAD, PTSD or SUD will be presented as continuous and categorical
 variables. Baseline characteristics of the intervention and control arms will be compared at
 the 5% level to assess if successful randomization was achieved. Data on potential
 confounders and effect modifiers, including variables that fail to achieve successful
 randomization (e.g. socio-demographic parameters) shall be used to control for confounding
 and effect modification. Between-subject analysis at week 4 will be used to assess the direct
 effect of the intervention by determining if there is a significant difference between the
 mean MHL scores in the intervention and control arms. Within-subject analysis will be
 performed among patients in the intervention arm by applying the Generalized Estimating
 Equations method on repeated measures data.

 Data safety management board: The data safety management board (DSMB) will be comprised of
 Prof Eugene Kinyanda (Psychiatrist and Senior Epidemiologist), Dr Moses Ocan (pharmacologist
 and IRB member), and Dr. Paul Bangirana (Clinical psychologist with vast experience in
 conducting RCT) from Makerere University. The PI will have periodic meetings with the DSMB
 and provide them with reports about the study activities using an agreed template. There will
 be at least two meetings during the study period one at the beginning and another midway
 through the study. Members of the DSMB will make a visit at the Butabika Hospital where data
 will be collected (phone calls) and stored. During this visit, the study procedures (SOPs and
 manuals), study responsibilities (delegation log), site facilities (call rooms/data room),
 study materials (stationary and administrative materials) and the recruitment and retention
 plan will be discussed.
Inclusion Criteria:

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

 Exclusion Criteria:

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