Psychoeducation for Patients With Bipolar Disorder in Rwanda
Phase: NA
Conditions: Bipolar Disorder
Sponsor: University of Aarhus

 
1 
 
Project title: Psychoeducation for patients with bipolar disorder 
NCT number: not yet assigned 
Study ID: AUUR2020DKRW 
Date: The 3rd of December 2020 
Document type: The study protocol 
 

 
2 
Project Protocol  
Psychoeducation for patients with Bipolar Disorders in Rwanda 
 
 
Project background 
Mental health and neurological disorders constitute 13% of the global burden of disease(1). 
Alarmingly this burden has risen by 41% in the last 20 years(2). In 2016, 18.5 million years 
were lost to disability due to mental health problems in the African region. In comparison, 
the disease burden of infectious and parasitic diseases in Africa was 13.1 million years lost to 
disability that same year(3). Currently, three out of four people with mental health problems 
live in low- and middle- income countries, where fewer than 1 in 50 people with severe 
mental disorders receive evidence-based treatment and in most countries less than 1% of the 
annual health budgets is allocated to mental health(4–6). The situation has been called both 
a failure of humanity and one of the most neglected global health issues of our time by some 
of the leading experts within the field of global health(7). 
 
Bipolar disorder (BD) is characterized by periodic episodes of elevated moods and 
depression, which co-occur with changes in activity or energy and is associated with 
cognitive, physical, and behavioural symptoms(8). 
 
It is estimated that severe mental disorders (i.e. severe depression, BD, schizophrenia and 
other psychotic disorders) have a two to three times higher average mortality compared to 
the general population(9). Treatment rates for these disorders are low in low-and-middle-
income countries (LMICs), where treatment gaps of more than 90% have been 
documented(10,11). This might explain why a considerable proportion – up to 50% - of 
individuals seeking care for mental disorders in Africa consult traditional and religious 
healers in their pathway to mental health care(12). 
One of the major barriers in decreasing the treatment gap is the lack of human resources. In 
response to the shortage of health professionals, experts and WHO advocate that mental 
health care must therefore be delegated to non-specialist health workers, who are trained to 
deliver interventions for specific mental disorders(13,14). 
 
In Rwanda, a Sub-Saharan country the size of Jutland and with around 12 million citizens, 
the total number of medical doctors specialized in mental health is 13 in the year of 2019. So 
far, no treatment guidelines on mental health disorders including BD exist in Rwanda. To 
date, there is no data on incidence, prevalence or prognosis for BD in Rwanda. 
 
Rwanda's health care system is organized along the principles of the WHO on primary health 
care(15,16). Health Centres are the first point of contact for patients. These centres also 
coordinate all outreach and prevention activities held at the community level, carried out by 
Community Health Workers (CHWs). The next level of care is the 41 District Hospitals, 
which has a mental health department staffed by a permanent team of psychiatric nurses and 
a psychologist. At the top of the mental health care system there are two national referral 
hospitals. The Neuropsychiatric Hospital of Ndera and the Mental Health Department of 
Kigali Teaching Hospital (CHUK), where only Ndera Hospital provides inpatient care. 
Statistics from the 2017 annual report at Ndera Hospital and CHUK shows that the annual 
numbers of outpatient visits with a diagnosis of BD were 1710 and 700, respectively. No data 
on BD is available on district or community level.  
 
The efficacy of psychoeducation as an add-on treatment to pharmacotherapy is well 
documented in the treatment of symptoms and in relapse prevention initiatives with respect 
to BD in western countries(17). Psychoeducation is believed to empower the patient to take 
an active role in the therapeutic process, thereby potentially reducing stigma, guilt, and 

 
3 
helplessness, as well as improving medical adherence and to engage caregivers(18). Yet, no 
studies on psychosocial interventions for BD have been conducted in a low-income 
country(19). 
 
In September 2014, the outpatient clinic of the Mental Health Department of Kigali Teaching 
Hospital launched a psychoeducation program for BD. The manual for the program is 
entitled “Life Goals Program” (LGP) and was designed back in 1996 by Bauer and 
McBride(20). LGP is a manual-based structured group psychotherapy program centered on 
behavioural principles from social education and self-regulation philosophies. Nevertheless, 
the effect of the psychoeducation in Rwanda is unexplored and psychoeducation is not part 
of the standard treatment.  
 
Given the enormous shortage of skilled mental health professionals in Rwanda the question 
that emerges is whether simple interventions such as psychoeducation could potentially be 
decentralized from the referral hospitals and be at least as effective and acceptable as those 
delivered by specialist health workers at the referral hospitals. 
 
Project aim  
 
The overall aim of the project is to determine the effect, feasibility and acceptability of 
psychoeducation for patients with BD in Rwanda at district level and referral-hospital level.  
Moreover, the study will explore current knowledge and practice of caregiving for individuals 
with BD among care providers in Rwanda.  
 
 
Objectives and hypothesis  
 
Specific objective 1: To collect descriptive data on inpatients at the only inpatient 
neuropsychiatric hospital in Rwanda as well as to collect data on the number of patients with 
BD receiving outpatient care at the referral hospitals in Rwanda. This descriptive 
information is crucial for understanding the service provision at the referral hospitals and 
the accessibility to intensive mental health care in Rwanda for patients with BD.  
 
Hypothesis 1: We hypothesise that admission data and outpatient data will demonstrate a 
considerable unmet need for mental health in Rwanda. 
  
Specific objective 2: To determine the feasibility, acceptability and effect of manual-based 
psychoeducation for patients with BD at the two national referral and teaching hospitals in 
Rwanda. 
 
Hypothesis 2: We hypothesise that the psychoeducation at the top level of mental health 
care for patients with BD will improve outcomes.  
 
Specific objective 3: To determine whether the establishment of a psychoeducation 
program for patients with BD at district level facilitated by district nurses, will be feasible 
and will show the same change over time as the psychoeducation provided by staff at 
hospital level. 
 
Hypothesis 3: We hypothesise that psychoeducation conducted by district mental health 
nurses are feasible and will have a positive effect on patient outcome. 
 
Specific Objective 4: To explore the perceptions and experiences with the mental health 

 
4 
system among patients with BD as well as their relatives to obtain information that can 
identify different treatment practices, and their efficacy including the use of traditional 
healers.  
 
Hypothesis 4: We hypothesise that patients with BD may have sought help other places 
than in the health care system for reasons like accessibility, stigma and culture. Moreover, 
we assume that they did not receive formal and evidence-based treatment before reaching 
the tertiary level of the health system and that the use of psychosocial interventions was 
limited.  
 
Specific Objective 5: To assess the experience, knowledge and practice of caregiving for 
individuals with BD among traditional and alternative healers (TAH), community health 
workers (CHWs) as well as the mental health nurses at the district hospital. The assessment 
will contribute to an understanding of the feasibility of providing treatment for patients at 
the district and community level.  
 
Hypothesis 5: We hypothesise that TAH as well as religious leaders are willing to 
collaborate with the formal health system. Moreover, we hypothesise that the CHWs and 
nurses want to provide evidence-based care including psychoeducation for patients with 
bipolar disorder but may lack the knowledge and skills 
 
Relevance 
 
Facing the enormous treatment gap for mental health as well as the tremendous lack of 
human resources for health, there is an urgent need for evidence-based operationally well-
documented innovations that are compatible with the realities at a population level in 
resource-constrained settings. Only a very limited number of studies in low- and middle-
income countries have been conducted on severe mental disorders. This project is essentially 
this quest. Potential positive outcomes may be effected not just in Rwanda, but also in 
similar low-resource settings elsewhere. If proven successful, relevant next steps will include 
having the newly established research group expand its focus area to severe mental health 
disorders other than BD; or to conduct studies on the drug treatment of BD in low-income 
settings. Moreover, the project will serve to enhance local research capacity. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
5 
Study design  
The study consists of a quantitative part and a qualitative part. 
 
The quantitative part is divided into a prospective randomized controlled trial (RCT), and a 
district trial (Figure 1) 
Figure 1: Project division 
 
 
 
 
 
 
 
 
 
 
 
 
*    A psychiatric nurse and either a psychologist or a psychiatric resident will conduct the psychoeducation.  
**  Two district mental health nurses will conduct the psychoeducation 
____ RCT 
-----The district trial 
 
Participants 
Inclusion criteria: A diagnosis of BD type I or II that meets DSM-V diagnostic criteria 
given by a trained psychiatrist and no episode in the preceding 4 weeks. Age ≥ 18 years. 
Exclusion criteria: Exclusion criteria will be applied to obtain a sample reflecting the 
general patient population. The exclusion criteria include: Previous participation in any 
structured psychological intervention, such as psychoeducation or cognitive remediation, 
mental retardation, insufficient understanding of Kinyarwanda or deafness, alcohol or drug-
dependence.  
 
Intervention groups: 
The RCT: Outpatients from the two-referral hospitals in Rwanda will be invited to 
participate and be allocated to intervention group or control group.  
 
Intervention-arm: Manual-structured group psychoeducation. LGP is organized in two 
phases. Phase 1 of the LGP psychoeducation is mandatory and entails 8 sessions of 90 
minutes over the course of 8 weeks (at one session per week) and has shown effect in 
western countries(21–23). Phase 2 will be offered after study completion. All groups will 
have 6-8 participants and two health professionals to conduct the sessions; a psychiatric 
nurse and either a psychologist or a psychiatric resident. Patients will be offered to invite 
their relatives for 2-3 psychoeducation-days for relatives.  
 
Control group: Participants in the control group will be assigned to a waiting list and receive 
group-psychoeducation after the active intervention groups.  
 
The district trial: This trial compares the impact of psychoeducation given at district level 
by district mental health nurses with the psychoeducation conducted at referral hospital 
(arm 1) 
 
Randomization: 
Study participants at the hospital level who meet the inclusion criteria and sign the informed 
consent form will be randomized individually into either intervention-arm or waiting list 
through block-randomization with a ratio of 1:1.  
District level**:
Patients with bipolar disorder
Group-psychoeducation for  
patients and relatives
Referral Hospital level*:
Patients with bipolar disorder
Randomization
Group-psychoeducation for  
patients and relatives 
(intervention -arm)
Controls (waiting list)

 
6 
Patients at district level will not be randomized since we are unsure of the number of 
patients with BD at these levels fearing that the sample size will be too small. Instead all will 
be offered participation. 
 
Outcome assessments: 
All outcomes will be assessed at baseline, immediately post-intervention and at the 3rd and 
6th month follow-up. The outcomes are based on the most commonly used measurements for 
trials on psychoeducation for individuals with BD in high and middle-income 
countries(18,19) 
Baseline data: The Mini-International Neuropsychiatric Interview(24) will be used to 
confirm psychiatric diagnosis. Demographic information regarding the participants’ living 
circumstances, past psychiatric history and mental health service use data will also be 
collected from interviews and patient files. 
Primary outcomes: Relapse is defined as a new mood episode of mania (scores above or 
equal to 20 on the Young Mania Rating Scale (YMRS)(25)), hypomania (above or equal to 12 
on the YMRS), or depression (above or equal to 17 on the Hamilton Depression Scale-
17(HDRS-17(26)) or mixed episode (above or equal to 20 on the YMRS and 12 on the HDRS-
17). 
Secondary outcomes: The Clinical Global Impression (CGI-I /CGI-S) will be used for the 
clinicans to assess how much the participant’s condition has improved. The Medication 
Adherence Rating scale (MARS) will be used to assess the adherence. All participants will fill 
in questions about self-stigma before and after the psychoeducation.  
Tertiary outcomes: A seven-item questionnaire based on The theoretical framework of 
acceptability(27) will be used to access the acceptability of the intervention. 
 
The Young Mania Rating Scale and The Medication Adherence Rating scale both needs to be 
cultural adapted and validated using a forward–backward translation, consensus conference 
and cognitive interviews (aprox. 15). 
 
Sample size: 
In the literature on group-psychoeducation, 13 out of 18 RCT’s have reduction in general 
psychiatric symptom severity, incidence of relapse and hospitalization as main 
outcomes(18). We reviewed 18 RCT’s on group psychoeducation for BD before we selected a 
study of Colom et al. as the base of our power calculation(18,28). The incidence of relapse in 
the study was (92%) (55 subjects) in the control group vs. 67% (40 subjects) in the 
psychoeducation group. For our study a sample size of 40 patients for each arm is required 
to achieve a level of 80% power with a 5% level of significance, when comparing the mean 
change in each intervention with the control arm via a two-sample t-test. Adjusting for a 
drop-out rate of 20%: 40/(1-(20/100))= 50 participants will be needed for each group. 
 
Finally, for a one-year period, descriptive data on all inpatients with age > 18 years, 
discharged from Ndera the only inpatient psychiatric hospital, will be collected from files. 
 
The qualitative part consists of three substudies. Each of the three substudies and their 
corresponding research question is outlined in Table 1, and the methodological approaches 
are described in further details in the following sections. 
 
 
 
 
 
 
 
 
 
 
 
 

 
7 
Table 1. Qualitative part 
# Substudy 
Research question 
Empirical data 
Methods 
1 Patients  
What is the living experience of adults with 
bipolar disorder in Rwanda? 
Semi-structured 
interviews (approx. 10-
20)  
 
Qualitative analysis 
 
 
 
2 Relatives 
How do relatives experience the mental 
health service system? What is the impact 
of caregiving on the caregiver and their 
living experince? 
Semi-structured 
interviews (approx. 10-
15)  
 
Qualitative analysis 
3 Care 
providers 
What knowledge, experience and practice  
of caregiving for individuals with BD do 
health providers in Rwanda have? Are TAH 
and religious leaders willing to collaborate 
with the formal health system? 
Focus groups (approx. 
4) 
Qualitative analysis  
 
 
Semi-structured qualitative interviews with patients will be conducted using the 
methodological framework of phenomenology to explore their personal use and experiences 
of mental health care in Rwanda. Patients will be recruited from the group-psychoeducation 
program. Patients’ relatives who sign up for psychoeducation-days for relatives will be asked 
if they want to participate in a semi-structured qualitative interview on the burden of 
caregiving.  
 
Focus groups will also be conducted with CHWs as well as mental health nurses at different 
district hospitals and TAH and religious leaders. The interviews will be transcribed in their 
full length. Data will be analysed to explore the experience, knowledge and practice of 
treatment provided at district- and community level for patients with Bipolar Disorder. 
 
Ethical Approval  
 
The research protocol and study-related documents will be presented to the Rwandan 
National Ethical Committee (RNEC) for approval prior to study initiation. Informed consent 
will be obtained from participants after oral and written information. 
 
A “twin model PhD project”: 
 
To ensure general capacity building extending further than our research team, we collaborate 
with a local partner institution in Rwanda – University of Rwanda. Furthermore, this 
research will be a ‘twin model’ PhD project(29) involving two PhD-students: Musoni Rwililza 
Emmanuel - a Rwandese psychiatrist and Caroline Juhl Arnbjerg-Nielsen – a Danish doctor. 
The twin model is based on the principles of local capacity building to ensure high scientific 
standards and participation by local stakeholders and prevents extractive research and 
scientific colonialism(29,30). This is in line with UN’s sustainable development agenda, goal 
17 on partnerships (31). The project will bring together three academic institutions in a 
partnership: Aarhus University (AU), University of Rwanda (UR) and Copenhagen 
University (Competence Centre for Transcultural Psychiatry). 
 
Segregation of duties 
The different tasks and responsibilities have been divided between the two PhD-students. 
Musoni Rwililza Emmanuel will mainly focus on psychoeducation at the district level and the 
qualitative part of the study (objective 3-4-5). Caroline Juhl Arnbjerg-Nielsen will be 

 
8 
Common trunk
Result dissemination 
and advocacy
responsible for the RCT and the data collection at the referral hospitals (objective 1-2). 
Figure 2 illustrates “The Twin PhD model” including the shared tasks and the division of 
responsibilities.  
 
 
Figure 2: Twin-PhD-model and the segregation of duties 
 
 
 
 
 
 
Feasibility  
 
The intervention chosen – The Life Goal Programme (LGP) – is already adapted and used in 
a Rwandan setting. Moreover, statistics from the 2017 annual report from the two referral 
hospitals show that the annual numbers of outpatient visits with a diagnosis of BD were 1710 
and 700 respectively, making it highly possible to include the required 150 participants from 
the referral hospitals. The research team is an interdisciplinary team comprised of 
professionals within the field of public health, transcultural psychiatry and psychology. The 
Rwandan PhD applicant holds professional experience in treating mental health patients in 
Rwanda as a trained psychiatrist; while the Danish PhD applicant has experience from 
DANIDA-related partnership projects in Rwanda.  
 
 
 
 
Data 
collection
Common trunk
Project aim: To determine the effect, feasibility 
and acceptability of psychoeducation for 
patients with BD in Rwanda.
Project development
Development of proposal
Twin 1
Exploring specific objectives 
number 1. og 2.
Twin 2
Exploring specific objectives 
number 3., 4. and 5. 
Cultural 
exchange
Knowledge 
exchange
Data and 
results 
exchange

 
9 
Research plan and timetable  
Our planned activities for the three-year project, starting in November of 2019, are 
presented in Table 2. We aim to initiate data-collection in the Summer of 2020. 
 
Table 2. Activities of the three-year project. 
Research activities 
Year 1 
Year 2 
Year 3 
  
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Development of the protocol and 
study related documents – 
applying for RNEC ethical approval 
  
  
  
  
  
  
  
  
  
  
  
  
Validate tools (YMRS and MARS)  
  
  
  
  
  
  
  
  
  
  
  
  
Development of focus-group 
questionnaire for caregivers 
  
  
  
  
  
  
  
  
  
  
  
  
Screening and enrolment of study 
participants for psychoeducation 
  
  
  
  
  
  
  
  
  
  
  
  
Follow-up 
  
  
  
  
  
  
  
  
  
  
  
  
Data collection on inpatients 
  
  
  
  
  
  
  
  
  
  
  
  
Data cleaning and analysis 
  
  
  
  
  
  
  
  
  
  
  
  
Authoring manuscripts 
  
  
  
  
  
  
  
  
  
  
  
  
Authoring dissertation 
  
  
  
  
  
  
  
  
  
  
  
  
 
Dissemination of research results 
The project aims at directing research and policy attention towards mental health at the 
global, national and local level. For the dissemination of the outcomes of the project, we will: 
a) publish articles in scientific journals; b) present results at international scientific meetings 
and conferences; c) organise local meetings with key stakeholders during the full extent of 
the project.  
 
Publications 
 The research project will result in several planned publications: 
1.  A descriptive analysis of inpatients with mental health disorders in Rwanda 
2. A randomized trial on the efficacy of group psychoeducation on recurrence, self-
stigma and medication adherence in individuals with bipolar disorder in Rwanda 
3. Caregiver burden in bipolar disorder: A study from Rwanda 
4. Feasibility and impact of group psycho-education at district level on quality of life, 
recurrence, self-stigma and medication adherence in individuals with bipolar 
disorder in Rwanda  
5. Knowledge, practices and attitudes towards bipolar disorder among traditional 
and religious healers in Rwanda.  
6. Mental health professionals’ perceptions of the use of traditional and alternative 
medicine in the care for patients with bipolar disorder in Rwanda.  
7. Rwandan traditional and religious healers’ perceptions towards western medicine.  
8. Pathways to psychiatric care and treatment of patients with bipolar disorder in 
Rwanda.  
 
 
 

 
10 
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