Bipolar DisorderNCT04671225
Psychoeducation for Patients With Bipolar Disorder in Rwanda
A study testing Groups Psychoeducation and Waiting-list in people with Bipolar Disorder, run by University of Aarhus at 2 sites in Rwanda.
Trial summary
Background: Mental health- and neurological disorders constitute 13% of the global burden of disease. Alarmingly this burden has risen by 41% in the last 20 years. In low-and-middle-income countries as few as 10% of people living with bipolar disorder receive care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Groups Psychoeducation and Waiting-list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesRwanda
- Study dates
- 15 Jan 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of BD type I or II that meets DSM-V diagnostic criteria given by a trained psychiatrist
- No episode in the preceding 4 weeks. Age ≥ 18 years.
Who cannot join
- Previous participation in any structured psychological intervention
- Insufficient understanding of Kinyarwanda
- Clinical evidence of substantial cognitive impairments.
- Alcohol or drug-dependence
Trial locations and contacts
2 sites in 1 country.
Rwanda2 sites
Ndera Hospital
Kigali
The University Teaching Hospital of Kigali (CHUK)
Kigali
About this study
Background: Mental health- and neurological disorders constitute 13% of the global burden of disease. Alarmingly this burden has risen by 41% in the last 20 years. In low-and-middle-income countries as few as 10% of people living with bipolar disorder receive care. In western countries, the efficacy of psychoeducation, as an add-on treatment to pharmacotherapy in the treatment of symptoms and in relapse prevention initiatives with respect to bipolar disorder, is well documented. Yet, few studies on psychosocial interventions for bipolar disorder have been conducted in a low-income country.
Aim: To determine the effect, feasibility and acceptability of psychoeducation for patients with bipolar disorder on all three levels of the health care system in Rwanda - at the community health centre, district- and university hospital.
Read more
Methods: Patients will be randomized into either group A) group-psychoeducation at a referral hospital; or B) group-psychoeducation for both patients and relatives or C) waiting list. Moreover a district trial will test the impact and feasibility of psychoeducation at the district level.
Outcomes: Reduction in symptom severity and incidence of relapse, improved quality of life, medical adherence and knowledge, as well as reduced self-stigmatization.
Perspectives: If proven successful, this is of importance for closing the huge treatment gap in mental health particularly affecting low- and middle-income countries and may reduce the mortality and increase quality of life in the population suffering from bipolar disorder. Furthermore, potential positive outcomes may be implemented in similar low-resource settings elsewhere.
Read the detailed description
Background: Mental health and neurological disorders constitute 13% of the global burden of diseases. Alarmingly this burden has risen by 41% in the last 20 years. It is estimated that severe mental disorders (i.e. severe depression, bipolar disorder, schizophrenia and other psychotic disorders) have a two to three times higher average mortality compared to the general population. Treatment rates for these disorders are low in low-and-middle-income countries (LMICs), where treatment gaps of more than 90% have been documented.
In western countries, the efficacy of psychoeducation, as an add-on treatment to pharmacotherapy in the treatment of symptoms and relapse prevention initiatives concerning bipolar disorder (BD), is well documented. Yet, few studies on psychosocial interventions for BD have been conducted in low-income countries.
The overall aim of the study is to determine the effect, feasibility and acceptability of psychoeducation for patients with BD in Rwanda.
Methods: The study is divided into a prospective randomized controlled trial (RCT) and a district trial. Patients with bipolar disease type I or II that meet DSM-V diagnostic criteria given by a trained psychiatrist and age ≥ 18 years will be invited to participate.
For the RCT study participants will be randomised to 1) group-psychoeducation for patients and relatives, 2) a waiting list. The RCT will take place at a referral hospital. The district trial compares the impact of psychoeducation given at the district level by mental health nurses with psychoeducation conducted at referral hospitals.
Intervention: Manual-structured group psychoeducation with eight sessions of 90 minutes over eight weeks (at one session per week). Patients will be offered to invite their relatives for 2-3 psychoeducation-days for relatives.
Outcomes: The primary outcome is a reduction in symptom severity, the incidence of relapse and hospitalization. Secondary outcomes include Improved quality of life and medication adherence and knowledge, as well as reduced self-stigmatization. All outcomes will be assessed at baseline, immediately post-intervention, and at the 3 and 6 months follow-up.
Sample size: In the literature on group-psychoeducation, 13 out of 18 RCT's have a reduction in general psychiatric symptom severity, the incidence of relapse and hospitalization as main outcomes. Eighteen RCT's on group psychoeducation for BD were reviewed before a study of Colom et al. was selected as the base of the power calculation. The incidence of relapse in the study was (92%) (55 subjects) in the control group vs 67% (40 subjects) in the psychoeducation group. For this 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 (50 for intervention, 50 for waiting-list and 50 for the district trial).
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.
Patients at the district level will not be randomized since the number of patients with BD at these levels is unknown and can result in the sample size will be too small. Instead, all will be offered participation.
Ethical Approval The research protocol and study-related documents have been approved by the College of Medicine and Health Sciences Institutional Review Board, Rwanda and The National Council for Science and Technology (NCST) in Rwanda.
- Conditions
- Bipolar Disorder
- Being tested
- Groups Psychoeducation, Waiting-list
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Groups PsychoeducationBehavioural
Manual-structured group psychoeducation with 8 sessions of 90 minutes over the course of 8 weeks (at one session per week). The manual is centred on behavioural principles from social education and self-regulation philosophies. 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.
Waiting-listBehavioural
Participants in the control group will be assigned to a waiting list and receive group-psychoeducation after the active intervention groups.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Psychoeducation at the referral hospital | Experimental | Intervention: Manual-structured group psychoeducation. Receives: Behavioral: Groups Psychoeducation |
| Waiting list - at the referral hospital | Other | Participants in the control group will be assigned to a waiting list and receive group-psychoeducation after the active intervention groups. Receives: Behavioral: Waiting-list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that relapse
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).
Measured: 1 year
Secondary outcomes (4)
Number of patient reporting improvement in medical adherence
Medication Adherence Rating Scale (MARS) will be used to assess beliefs and barriers to medication adherence. Total scores on the MARS may range between 0 and 10, with a higher score indicating better medication adherence.
Measured: 1 year
Number of patient reporting reduction in self-stigma
Internalized Stigma of Mental Illness Inventory - 9-item Version (ISMI-9) will be used to assess self-stigma. The resulting score should range from 1 to 4. A score ranging between 1.00-2.50: does not report high internalized stigma vs. a score ranging between 2.51-4.00: indicating high internalized stigma
Measured: 1 year
Improvement of illness severity
The Clinical Global Impression (CGI-I /CGI-S) will be used for the clinicians to assess how much the participant's condition has improved. The first scale: CGI-Severity (CGI-S) rates illness severity at baseline. The score range between 1 and 7with a higher score indicating serve illness.
The other scale CGI-Improvement (CGI-I) tracks improvement after initiation of treatment on a scale from 1 to 7. Four indicates no change. A low score indicates improvement and a high score of worsening symptoms.
Measured: 1 year
Acceptability of the intervention
A seven-item questionnaire based on The theoretical framework of acceptability will be used to access the acceptability of the intervention.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start15 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The RCT: Outpatients from the two-referral hospitals in Rwanda will be invited to participate and be allocated to the intervention group or waiting list. The district trial: This trial compares the impact of the intervention given at the district level with the intervention conducted at the referral hospital. 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. Patients at the district level will not be randomized since we are unsure of the number of patients with Bipolar Disorder at these levels fearing that the sample size will be too small. Instead, all will be offered participation.
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rwanda, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Responsible party
- Sponsor
- Investigators
- Per Kallestrup, Prof., Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671225
- Sponsor's protocol ID
- AUUR2020DKRW
- Status last verified
- Nov 2020
- First submitted
- 24 Nov 2020
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vigo D, Thornicroft G, Atun R. Estimating the true global burden of mental illness. Lancet Psychiatry. 2016 Feb;3(2):171-8. doi: 10.1016/S2215-0366(15)00505-2.
PubMed 26851330Whiteford HA, Ferrari AJ, Degenhardt L, Feigin V, Vos T. The global burden of mental, neurological and substance use disorders: an analysis from the Global Burden of Disease Study 2010. PLoS One. 2015 Feb 6;10(2):e0116820. doi: 10.1371/journal.pone.0116820. eCollection 2015.
PubMed 25658103Gilbert BJ, Patel V, Farmer PE, Lu C. Assessing development assistance for mental health in developing countries: 2007-2013. PLoS Med. 2015 Jun 2;12(6):e1001834. doi: 10.1371/journal.pmed.1001834. eCollection 2015 Jun.
PubMed 26035429Rathod S, Pinninti N, Irfan M, Gorczynski P, Rathod P, Gega L, Naeem F. Mental Health Service Provision in Low- and Middle-Income Countries. Health Serv Insights. 2017 Mar 28;10:1178632917694350. doi: 10.1177/1178632917694350. eCollection 2017.
PubMed 28469456Mackenzie J, Kesner C. Mental health funding and the SDGs What now and who pays ? 2016;(May).
Kleinman A. Global mental health: a failure of humanity. Lancet. 2009 Aug 22;374(9690):603-4. doi: 10.1016/s0140-6736(09)61510-5. No abstract available.
PubMed 19708102Liu NH, Daumit GL, Dua T, Aquila R, Charlson F, Cuijpers P, Druss B, Dudek K, Freeman M, Fujii C, Gaebel W, Hegerl U, Levav I, Munk Laursen T, Ma H, Maj M, Elena Medina-Mora M, Nordentoft M, Prabhakaran D, Pratt K, Prince M, Rangaswamy T, Shiers D, Susser E, Thornicroft G, Wahlbeck K, Fekadu Wassie A, Whiteford H, Saxena S. Excess mortality in persons with severe mental disorders: a multilevel intervention framework and priorities for clinical practice, policy and research agendas. World Psychiatry. 2017 Feb;16(1):30-40. doi: 10.1002/wps.20384.
PubMed 28127922Kohn R, Saxena S, Levav I, Saraceno B. The treatment gap in mental health care. Bull World Health Organ. 2004 Nov;82(11):858-66. Epub 2004 Dec 14.
PubMed 15640922Sankoh O, Sevalie S, Weston M. Mental health in Africa. Lancet Glob Health. 2018 Sep;6(9):e954-e955. doi: 10.1016/S2214-109X(18)30303-6. No abstract available.
PubMed 30103990Burns JK, Tomita A. Traditional and religious healers in the pathway to care for people with mental disorders in Africa: a systematic review and meta-analysis. Soc Psychiatry Psychiatr Epidemiol. 2015 Jun;50(6):867-77. doi: 10.1007/s00127-014-0989-7. Epub 2014 Dec 12.
PubMed 25515608Keynejad RC, Dua T, Barbui C, Thornicroft G. WHO Mental Health Gap Action Programme (mhGAP) Intervention Guide: a systematic review of evidence from low and middle-income countries. Evid Based Ment Health. 2018 Feb;21(1):30-34. doi: 10.1136/eb-2017-102750. Epub 2017 Sep 13.
PubMed 28903977Patel V. Global mental health: from science to action. Harv Rev Psychiatry. 2012 Jan-Feb;20(1):6-12. doi: 10.3109/10673229.2012.649108.
PubMed 22335178Colom F. The evolution of psychoeducation for bipolar disorder: from lithium clinics to integrative psychoeducation. World Psychiatry. 2014 Feb;13(1):90-2. doi: 10.1002/wps.20091. No abstract available.
PubMed 24497258Soo SA, Zhang ZW, Khong SJ, Low JEW, Thambyrajah VS, Alhabsyi SHBT, Chew QH, Sum MY, Sengupta S, Vieta E, McIntyre RS, Sim K. Randomized Controlled Trials of Psychoeducation Modalities in the Management of Bipolar Disorder: A Systematic Review. J Clin Psychiatry. 2018 May/Jun;79(3):17r11750. doi: 10.4088/JCP.17r11750.
PubMed 29727072Demissie M, Hanlon C, Birhane R, Ng L, Medhin G, Fekadu A. Psychological interventions for bipolar disorder in low- and middle-income countries: systematic review. BJPsych Open. 2018 Aug 30;4(5):375-384. doi: 10.1192/bjo.2018.46. eCollection 2018 Sep.
PubMed 30202599
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducation for Patients With Bipolar Disorder in Rwanda
- ClinicalTrials.gov ID
- NCT04671225
- Acronym / sponsor ID
- AUUR2020DKRW
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Rwanda, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Mental health- and neurological disorders constitute 13% of the global burden of disease. Alarmingly this burden has risen by 41% in the last 20 years. In low-and-middle-income countries as few as 10% of people living with bipolar disorder receive care. In western countries, the efficacy of psychoeducation, as an add-on treatment to pharmacotherapy in the treatment of symptoms and in relapse prevention initiatives with respect to bipolar disorder, is well documented. Yet, few studies on psychosocial interventions for bipolar disorder have been conducted in a low-income country.
Aim: To determine the effect, feasibility and acceptability of psychoeducation for patients with bipolar disorder on all three levels of the health care system in Rwanda - at the community health centre, district- and university hospital.
Methods: Patients will be randomized into either group A) group-psychoeducation at a referral hospital; or B) group-psychoeducation for both patients and relatives or C) waiting list. Moreover a district trial will test the impact and feasibility of psychoeducation at the district level.
Outcomes: Reduction in symptom severity and incidence of relapse, improved quality of life, medical adherence and knowledge, as well as reduced self-stigmatization.
Perspectives: If proven successful, this is of importance for closing the huge treatment gap in mental health particularly affecting low- and middle-income countries and may reduce the mortality and increase quality of life in the population suffering from bipolar disorder. Furthermore, potential positive outcomes may be implemented in similar low-resource settings elsewhere.
Detailed description
Background: Mental health and neurological disorders constitute 13% of the global burden of diseases. Alarmingly this burden has risen by 41% in the last 20 years. It is estimated that severe mental disorders (i.e. severe depression, bipolar disorder, schizophrenia and other psychotic disorders) have a two to three times higher average mortality compared to the general population. Treatment rates for these disorders are low in low-and-middle-income countries (LMICs), where treatment gaps of more than 90% have been documented.
In western countries, the efficacy of psychoeducation, as an add-on treatment to pharmacotherapy in the treatment of symptoms and relapse prevention initiatives concerning bipolar disorder (BD), is well documented. Yet, few studies on psychosocial interventions for BD have been conducted in low-income countries.
The overall aim of the study is to determine the effect, feasibility and acceptability of psychoeducation for patients with BD in Rwanda.
Methods: The study is divided into a prospective randomized controlled trial (RCT) and a district trial. Patients with bipolar disease type I or II that meet DSM-V diagnostic criteria given by a trained psychiatrist and age ≥ 18 years will be invited to participate.
For the RCT study participants will be randomised to 1) group-psychoeducation for patients and relatives, 2) a waiting list. The RCT will take place at a referral hospital. The district trial compares the impact of psychoeducation given at the district level by mental health nurses with psychoeducation conducted at referral hospitals.
Intervention: Manual-structured group psychoeducation with eight sessions of 90 minutes over eight weeks (at one session per week). Patients will be offered to invite their relatives for 2-3 psychoeducation-days for relatives.
Outcomes: The primary outcome is a reduction in symptom severity, the incidence of relapse and hospitalization. Secondary outcomes include Improved quality of life and medication adherence and knowledge, as well as reduced self-stigmatization. All outcomes will be assessed at baseline, immediately post-intervention, and at the 3 and 6 months follow-up.
Sample size: In the literature on group-psychoeducation, 13 out of 18 RCT's have a reduction in general psychiatric symptom severity, the incidence of relapse and hospitalization as main outcomes. Eighteen RCT's on group psychoeducation for BD were reviewed before a study of Colom et al. was selected as the base of the power calculation. The incidence of relapse in the study was (92%) (55 subjects) in the control group vs 67% (40 subjects) in the psychoeducation group. For this 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 (50 for intervention, 50 for waiting-list and 50 for the district trial).
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.
Patients at the district level will not be randomized since the number of patients with BD at these levels is unknown and can result in the sample size will be too small. Instead, all will be offered participation.
Ethical Approval The research protocol and study-related documents have been approved by the College of Medicine and Health Sciences Institutional Review Board, Rwanda and The National Council for Science and Technology (NCST) in Rwanda.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The RCT: Outpatients from the two-referral hospitals in Rwanda will be invited to participate and be allocated to the intervention group or waiting list. The district trial: This trial compares the impact of the intervention given at the district level with the intervention conducted at the referral hospital. 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. Patients at the district level will not be randomized since we are unsure of the number of patients with Bipolar Disorder at these levels fearing that the sample size will be too small. Instead, all will be offered participation.
| Arm | Type | Receives |
|---|---|---|
| Intervention - Psychoeducation at the referral hospital | Experimental | Behavioral: Groups PsychoeducationIntervention: Manual-structured group psychoeducation. |
| Waiting list - at the referral hospital | Other | Behavioral: Waiting-listParticipants in the control group will be assigned to a waiting list and receive group-psychoeducation after the active intervention groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of BD type I or II that meets DSM-V diagnostic criteria given by a trained psychiatrist
- No episode in the preceding 4 weeks. Age ≥ 18 years.
Key exclusion criteria (4 listed)
- Previous participation in any structured psychological intervention
- Insufficient understanding of Kinyarwanda
- Clinical evidence of substantial cognitive impairments.
- Alcohol or drug-dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Groups PsychoeducationManual-structured group psychoeducation with 8 sessions of 90 minutes over the course of 8 weeks (at one session per week). The manual is centred on behavioural principles from social education and self-regulation philosophies. 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. | Behavioural | Intervention - Psychoeducation at the referral hospital |
| Waiting-listParticipants in the control group will be assigned to a waiting list and receive group-psychoeducation after the active intervention groups. | Behavioural | Waiting list - at the referral hospital |
Primary outcome
Number of patients that relapse
Time frame: 1 year
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).
4 secondary outcomes
Number of patient reporting improvement in medical adherence
Time frame: 1 year
Number of patient reporting reduction in self-stigma
Time frame: 1 year
Improvement of illness severity
Time frame: 1 year
Acceptability of the intervention
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Background: PubMed 26851330Vigo D, Thornicroft G, Atun R. Estimating the true global burden of mental illness. Lancet Psychiatry. 2016 Feb;3(2):171-8. doi: 10.1016/S2215-0366(15)00505-2.
- Background: PubMed 25658103Whiteford HA, Ferrari AJ, Degenhardt L, Feigin V, Vos T. The global burden of mental, neurological and substance use disorders: an analysis from the Global Burden of Disease Study 2010. PLoS One. 2015 Feb 6;10(2):e0116820. doi: 10.1371/journal.pone.0116820. eCollection 2015.
- Background: PubMed 26035429Gilbert BJ, Patel V, Farmer PE, Lu C. Assessing development assistance for mental health in developing countries: 2007-2013. PLoS Med. 2015 Jun 2;12(6):e1001834. doi: 10.1371/journal.pmed.1001834. eCollection 2015 Jun.
- Background: PubMed 28469456Rathod S, Pinninti N, Irfan M, Gorczynski P, Rathod P, Gega L, Naeem F. Mental Health Service Provision in Low- and Middle-Income Countries. Health Serv Insights. 2017 Mar 28;10:1178632917694350. doi: 10.1177/1178632917694350. eCollection 2017.
- BackgroundMackenzie J, Kesner C. Mental health funding and the SDGs What now and who pays ? 2016;(May).
- Background: PubMed 19708102Kleinman A. Global mental health: a failure of humanity. Lancet. 2009 Aug 22;374(9690):603-4. doi: 10.1016/s0140-6736(09)61510-5. No abstract available.
- Background: PubMed 28127922Liu NH, Daumit GL, Dua T, Aquila R, Charlson F, Cuijpers P, Druss B, Dudek K, Freeman M, Fujii C, Gaebel W, Hegerl U, Levav I, Munk Laursen T, Ma H, Maj M, Elena Medina-Mora M, Nordentoft M, Prabhakaran D, Pratt K, Prince M, Rangaswamy T, Shiers D, Susser E, Thornicroft G, Wahlbeck K, Fekadu Wassie A, Whiteford H, Saxena S. Excess mortality in persons with severe mental disorders: a multilevel intervention framework and priorities for clinical practice, policy and research agendas. World Psychiatry. 2017 Feb;16(1):30-40. doi: 10.1002/wps.20384.
- Background: PubMed 15640922Kohn R, Saxena S, Levav I, Saraceno B. The treatment gap in mental health care. Bull World Health Organ. 2004 Nov;82(11):858-66. Epub 2004 Dec 14.
- Background: PubMed 30103990Sankoh O, Sevalie S, Weston M. Mental health in Africa. Lancet Glob Health. 2018 Sep;6(9):e954-e955. doi: 10.1016/S2214-109X(18)30303-6. No abstract available.
- Background: PubMed 25515608Burns JK, Tomita A. Traditional and religious healers in the pathway to care for people with mental disorders in Africa: a systematic review and meta-analysis. Soc Psychiatry Psychiatr Epidemiol. 2015 Jun;50(6):867-77. doi: 10.1007/s00127-014-0989-7. Epub 2014 Dec 12.
- Background: PubMed 28903977Keynejad RC, Dua T, Barbui C, Thornicroft G. WHO Mental Health Gap Action Programme (mhGAP) Intervention Guide: a systematic review of evidence from low and middle-income countries. Evid Based Ment Health. 2018 Feb;21(1):30-34. doi: 10.1136/eb-2017-102750. Epub 2017 Sep 13.
- Background: PubMed 22335178Patel V. Global mental health: from science to action. Harv Rev Psychiatry. 2012 Jan-Feb;20(1):6-12. doi: 10.3109/10673229.2012.649108.
- WHO. Global Health Estimates 2016: Burden of disease by cause, age, sex, by country and by region, 2000-2016. 2018.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Kallestrup, Prof. study chair
University of Aarhus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Groups Psychoeducation and Waiting-list in people with Bipolar Disorder, run by University of Aarhus at 2 sites in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that relapse (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04671225, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.