Viewing Study NCT04616989



Ignite Creation Date: 2024-05-06 @ 3:23 PM
Last Modification Date: 2024-10-26 @ 1:48 PM
Study NCT ID: NCT04616989
Status: COMPLETED
Last Update Posted: 2021-06-02
First Post: 2020-10-20

Brief Title: Mental Health in Communities Affected by COVID-19 in Uganda
Sponsor: Makerere University
Organization: Makerere University

Study Overview

Official Title: Integration of Mental Health Care in Communities Affected by the COVID-19 Pandemic in Central Uganda
Status: COMPLETED
Status Verified Date: 2021-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 individuals 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 n12 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 n12 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 dont 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
Detailed Description: Study design The investigators will use a multi-stage open-label cluster-randomized trial of 24 randomly chosen villages n12 intervention and n12 control in Kampala n15 Wakiso n3 Mukono n4 and Masaka n2 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 parishesvillages 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 471038 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 participants telephone contact and provide it to the project administrator who will pass them to research assistants Individuals who dont 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 VHTs 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 privacyconfidentiality then the investigators will report it promptly reported to the SOMRECUNCST

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 cant 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-pE2 n- sample size E-The standard error 5 p- Proportion of patients 50The 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 196 corresponding to 95 confidence interval Substituting n1962 X 05 X 1-050052 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 1414 and standard deviation SD of 219 cluster-size of 35 participants and coefficient of variation of 025 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 eg 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 roomsdata room study materials stationary and administrative materials and the recruitment and retention plan will be discussed

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None