KnowledgeNCT04728243
WHO QualityRights E-training in Ghana
A study testing WHO QualityRights e-training and WHO COVID-19 online training in people with Knowledge and Attitudes, run by Mental Health Society of Ghana at 3 sites in Ghana.
Trial summary
This is a cluster randomized controlled trial to determine the efficacy of the WHO QR online training compared with a placebo intervention in improving the knowledge about human rights, the attitudes towards people with psychosocial disabilities, and the practices related to substitute-decision making and coercion… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- WHO QualityRights e-training and WHO COVID-19 online training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 3 sitesGhana
- Study dates
- 11 Aug 2021to 19 Jan 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to speak English. English is an official language of Ghana and is used as a lingua franca throughout the country. English is also the most used of the eleven official languages spoken in Ghana .
- Mental health professionals currently working in the in-patient units of the three psychiatric hospitals selected for the study (all in the Accra area)
Who cannot join
- Persons who participated to the in-person WHO QualityRights trainings held in Ghana.
- Persons enrolled in the online WHO QualityRights training. .
Trial locations and contacts
3 sites in 1 country.
Ghana3 sites
Accra Psychiatric Hospital
Accra
Pantang Psychiatric Hospital
Accra
Ankaful Psychiatric Hospital
Cape Coast, Central Region
About this study
Official title: WHO QualityRights Online Training for Mental Health Workers in Ghana
This is a cluster randomized controlled trial to determine the efficacy of the WHO QR online training compared with a placebo intervention in improving the knowledge about human rights, the attitudes towards people with psychosocial disabilities, and the practices related to substitute-decision making and coercion among mental health professionals.
Given the impact human rights violations have on the health of persons with psychosocial disabilities, an effort is needed to carry out methodologically strong research in this area. The study proposed will provide robust evidence to support further investment in interventions such as the WHO QualityRights training and make steps forward promoting the rights of people with psychosocial disabilities.
Read the detailed description
Background. People with psychosocial disabilities are commonly exposed to human rights violations within the mental health care system and in the general community. Such violations occur in all countries and are not only a problem from an ethical point of view but additionally have profound repercussions on the health of persons with psychosocial disabilities. Although psychiatric facilities are the very institutions responsible for the care and support of people with psychosocial disabilities, they are also often places in which persons with psychosocial disabilities are victims of inhumane treatments, including psychological, physical, and sexual abuse or violence. To stop these human rights violations, there is a need to reform mental health systems and thus change mental health professionals' practices leading to violations of people with psychosocial disabilities' rights. However, for this to happen, two main barriers need to be addressed. One barrier is the lack of human rights literacy among mental health professionals. The second barrier is that many mental health professionals hold negative attitudes towards people with psychosocial disabilities.
Recently, the World Health Organization (WHO) has developed the QualityRights (QR) online training. This training includes modules to increase knowledge about the rights of people with psychosocial disabilities and change the negative attitudes towards them and their role as rights holders. Furthermore, the training provides mental health providers with the skills necessary to advocate for a human rights-based approach in mental health. Currently, there is a growing interest in the QualityRights training, and the WHO is implementing it in different countries. However, the efficacy of this intervention has not been rigorously evaluated.
Objectives. To determine the efficacy of the QR online training compared with a placebo intervention (online training on Coronavirus Disease - 2019) in improving the knowledge about human rights, the attitudes towards people with psychosocial disabilities, and the practices related to substitute-decision making and coercion among mental health professionals.
Methods. This is a cluster randomized controlled trial (cRCT) being conducted in Ghana. An estimated sample of 252 mental health professionals will be recruited from across 28 clusters within three psychiatric hospitals. Participants will be divided in two arms to receive either the WHO QR online training on human rights issues in mental health or the WHO Coronavirus online training for health professionals. The primary outcomes, assessed post-training, at 3 months, and at 6 months are increase in the knowledge about human rights and mental health and improvement on the attitudes towards persons with psychosocial disabilities. Secondary outcomes, assessed at 3 and 6 months, consist of improvements in the mental health professionals' practices, burn-out levels, and well-being. All data will be collected online.
Discussion. Given the impact human rights violations have on the health of persons with psychosocial disabilities, an effort is needed to carry out methodologically strong research in this area. The study proposed will provide robust evidence to support further investment in interventions such as the WHO QualityRights training and make steps forward promoting the rights of people with psychosocial disabilities.
- Being tested
- WHO QualityRights e-training, WHO COVID-19 online training
- Keywords
- mental health, human rights, RCT, Ghana, online training
- Medical subject headings
- Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO QualityRights e-trainingOther
The WHO QualityRights online training aims to increase knowledge about the rights of people with psychosocial disabilities and change negative attitudes towards these persons and their role as rights holders. Furthermore, the training provides mental health professionals with the skills necessary to support people with psychosocial disabilities to advocate for their rights. The WHO QualityRights online training includes five core modules: 1) Human rights; 2) Mental health, disability, and human rights; 3) The right to health and recovery; 4) Legal capacity and the right to decide; 5) Free from coercion, violence, and abuse. Each module is composed of presentations, videos, interactive exercises, and forum discussions involving all participants. In the online training forum discussions, particular attention will be given to issues relevant to the Ghanaian context.
WHO COVID-19 online trainingOther
The WHO novel coronavirus 2019 online training series provides a general introduction to COVID-19 and similar respiratory infections and information on what facilities and professionals should be doing to prevent and respond to COVID-19 cases. The training is similar in length to the WHO QualityRights training (13 h 15 min vs. 19 hours) and is intended for health professionals and other stakeholders.
| Study group | Role | What they receive |
|---|---|---|
| WHO QualityRights | Experimental | Mental health professionals assigned to the experimental arm will be enrolled in the WHO QualityRights online training. Receives: Other: WHO QualityRights e-training |
| WHO Coronavirus Disease of 2019 (COVID19) | Placebo comparator | Mental health professionals assigned to the control arm will be enrolled in the WHO novel coronavirus 2019 online training series. Receives: Other: WHO COVID-19 online training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline knowledge about human rights of persons with psychosocial disabilities post-training
World Health Organization's Knowledge about the Rights of persons with psychosocial disabilities questionnaire: Questionnaire to assess knowledge about the rights included in the United Nations Convention on the Rights of Persons with Disabilities. Scores range between 0 and 23. Higher score indicates higher level of knowledge.
Measured: pre-training, immediately post-training
Change from Baseline attitudes towards persons with psychosocial disabilities role as rights-holders post-training
World Health Organization's questionnaire on the attitudes towards people with psychosocial disabilities as rights-holders. Scores range between 17 and 85. Higher score indicates more negative attitudes.
Measured: pre-training, immediately post-training
Secondary outcomes (4)
Change from Baseline Practices related to substitute-decision making and coercion scale at 3 months
Practices related to substitute-decision making and coercion questionnaire. Scale to measure the use of substitute-decision making and coercive practices in mental health units. This questionnaire includes two sub-scales. The first range is between 7 and 49. A high score indicates practices related to substitute-decision making and coercion are used frequently by the respondent. The second range is between 5 and 25. High scores indicate that the mental health professionals working in the units of the respondents are more willing to use practices related to substitute-decision making and coercion than they are.
Measured: pre-training, at 3 months
Change from Baseline Seclusion and Restraint Experience post-training
Seclusion and Restraint Experience Questionnaire (SREQ) - modified version. Questionnaire to measure emotional and ethical experiences linked to the use of seclusion and restraint among health professionals. Scores range between 25 and 100. Higher scores indicates higher endorsement of specific experiences.
Measured: pre-training, immediately post-training
Change from Baseline Burnout at 3 months
Abbreviated Maslach Burnout Inventory (MBI). Inventory to measure burn-out among health professionals. Scores range between 9 and 27. Higher scores indicate higher burnout.
Measured: pre-training, at 3 months
Change from Baseline Quality of Life at 3 months
World Health Organization Quality of Life (WHOQOL-BREF)Questionnaire to measure quality of life during the last month. Scores range between 0 and 100. Higher scores denote higher quality of life.
Measured: pre-training, at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start11 Aug 2021
- Primary completion19 Jul 2022
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KnowledgeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Society of Ghana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cagliari, Columbia University, World Health Organization, Mental Health Authority of Ghana
- Responsible party
- Principal investigator, Maria Francesca Moro, Columbia University
- Investigators
- Maria Francesca Moro, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728243
- Sponsor's protocol ID
- 2021_1
- Status last verified
- Feb 2023
- First submitted
- 20 Jan 2021
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A coded dataset, with no confidential information, will be shared with researchers at Columbia University for data analysis collaboration
Publications
Moro MF, Gyimah L, Susser E, Ansong J, Kane JC, Osei A, Gureje O, Kofie H, Taylor D, Drew N, Ohene SA, Fatawu A, Addico NL, Atzeni M, D'Oca S, Funk M, Carta MG. Evaluating the efficacy of the WHO QualityRights e-training in promoting the rights of persons with mental health conditions and psychosocial disabilities: a cluster randomised controlled trial in Ghana. BMJ Glob Health. 2025 Dec 9;10(12):e021215. doi: 10.1136/bmjgh-2025-021215.
PubMed 41365627
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WHO QualityRights Online Training for Mental Health Workers in Ghana
- ClinicalTrials.gov ID
- NCT04728243
- Acronym / sponsor ID
- 2021_1
- Keywords
- mental health, human rights, RCT, Ghana, online training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Mental Health Society of GhanaUniversity, hospital or other
- Collaborators
- University of Cagliari, Columbia University, World Health Organization, Mental Health Authority of Ghana
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 28 Jan 2021 (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.
This is a cluster randomized controlled trial to determine the efficacy of the WHO QR online training compared with a placebo intervention in improving the knowledge about human rights, the attitudes towards people with psychosocial disabilities, and the practices related to substitute-decision making and coercion among mental health professionals.
Given the impact human rights violations have on the health of persons with psychosocial disabilities, an effort is needed to carry out methodologically strong research in this area. The study proposed will provide robust evidence to support further investment in interventions such as the WHO QualityRights training and make steps forward promoting the rights of people with psychosocial disabilities.
Detailed description
Background. People with psychosocial disabilities are commonly exposed to human rights violations within the mental health care system and in the general community. Such violations occur in all countries and are not only a problem from an ethical point of view but additionally have profound repercussions on the health of persons with psychosocial disabilities. Although psychiatric facilities are the very institutions responsible for the care and support of people with psychosocial disabilities, they are also often places in which persons with psychosocial disabilities are victims of inhumane treatments, including psychological, physical, and sexual abuse or violence. To stop these human rights violations, there is a need to reform mental health systems and thus change mental health professionals' practices leading to violations of people with psychosocial disabilities' rights. However, for this to happen, two main barriers need to be addressed. One barrier is the lack of human rights literacy among mental health professionals. The second barrier is that many mental health professionals hold negative attitudes towards people with psychosocial disabilities.
Recently, the World Health Organization (WHO) has developed the QualityRights (QR) online training. This training includes modules to increase knowledge about the rights of people with psychosocial disabilities and change the negative attitudes towards them and their role as rights holders. Furthermore, the training provides mental health providers with the skills necessary to advocate for a human rights-based approach in mental health. Currently, there is a growing interest in the QualityRights training, and the WHO is implementing it in different countries. However, the efficacy of this intervention has not been rigorously evaluated.
Objectives. To determine the efficacy of the QR online training compared with a placebo intervention (online training on Coronavirus Disease - 2019) in improving the knowledge about human rights, the attitudes towards people with psychosocial disabilities, and the practices related to substitute-decision making and coercion among mental health professionals.
Methods. This is a cluster randomized controlled trial (cRCT) being conducted in Ghana. An estimated sample of 252 mental health professionals will be recruited from across 28 clusters within three psychiatric hospitals. Participants will be divided in two arms to receive either the WHO QR online training on human rights issues in mental health or the WHO Coronavirus online training for health professionals. The primary outcomes, assessed post-training, at 3 months, and at 6 months are increase in the knowledge about human rights and mental health and improvement on the attitudes towards persons with psychosocial disabilities. Secondary outcomes, assessed at 3 and 6 months, consist of improvements in the mental health professionals' practices, burn-out levels, and well-being. All data will be collected online.
Discussion. Given the impact human rights violations have on the health of persons with psychosocial disabilities, an effort is needed to carry out methodologically strong research in this area. The study proposed will provide robust evidence to support further investment in interventions such as the WHO QualityRights training and make steps forward promoting the rights of people with psychosocial disabilities.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WHO QualityRights | Experimental | Other: WHO QualityRights e-trainingMental health professionals assigned to the experimental arm will be enrolled in the WHO QualityRights online training. |
| WHO Coronavirus Disease of 2019 (COVID19) | Placebo comparator | Other: WHO COVID-19 online trainingMental health professionals assigned to the control arm will be enrolled in the WHO novel coronavirus 2019 online training series. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to speak English. English is an official language of Ghana and is used as a lingua franca throughout the country. English is also the most used of the eleven official languages spoken in Ghana .
- Mental health professionals currently working in the in-patient units of the three psychiatric hospitals selected for the study (all in the Accra area)
Key exclusion criteria (2 listed)
- Persons who participated to the in-person WHO QualityRights trainings held in Ghana.
- Persons enrolled in the online WHO QualityRights training. .
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 |
|---|---|---|
| WHO QualityRights e-trainingThe WHO QualityRights online training aims to increase knowledge about the rights of people with psychosocial disabilities and change negative attitudes towards these persons and their role as rights holders. Furthermore, the training provides mental health professionals with the skills necessary to support people with psychosocial disabilities to advocate for their rights. The WHO QualityRights online training includes five core modules: 1) Human rights; 2) Mental health, disability, and human rights; 3) The right to health and recovery; 4) Legal capacity and the right to decide; 5) Free from coercion, violence, and abuse. Each module is composed of presentations, videos, interactive exercises, and forum discussions involving all participants. In the online training forum discussions, particular attention will be given to issues relevant to the Ghanaian context. | Other | WHO QualityRights |
| WHO COVID-19 online trainingThe WHO novel coronavirus 2019 online training series provides a general introduction to COVID-19 and similar respiratory infections and information on what facilities and professionals should be doing to prevent and respond to COVID-19 cases. The training is similar in length to the WHO QualityRights training (13 h 15 min vs. 19 hours) and is intended for health professionals and other stakeholders. | Other | WHO Coronavirus Disease of 2019 (COVID19) |
Primary outcome
Change from Baseline knowledge about human rights of persons with psychosocial disabilities post-training
Time frame: pre-training, immediately post-training
World Health Organization's Knowledge about the Rights of persons with psychosocial disabilities questionnaire: Questionnaire to assess knowledge about the rights included in the United Nations Convention on the Rights of Persons with Disabilities. Scores range between 0 and 23. Higher score indicates higher level of knowledge.
Change from Baseline attitudes towards persons with psychosocial disabilities role as rights-holders post-training
Time frame: pre-training, immediately post-training
World Health Organization's questionnaire on the attitudes towards people with psychosocial disabilities as rights-holders. Scores range between 17 and 85. Higher score indicates more negative attitudes.
4 secondary outcomes
Change from Baseline Practices related to substitute-decision making and coercion scale at 3 months
Time frame: pre-training, at 3 months
Change from Baseline Seclusion and Restraint Experience post-training
Time frame: pre-training, immediately post-training
Change from Baseline Burnout at 3 months
Time frame: pre-training, at 3 months
Change from Baseline Quality of Life at 3 months
Time frame: pre-training, at 3 months
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 15 Feb 2023.
- Derived from this study: PubMed 41365627Moro MF, Gyimah L, Susser E, Ansong J, Kane JC, Osei A, Gureje O, Kofie H, Taylor D, Drew N, Ohene SA, Fatawu A, Addico NL, Atzeni M, D'Oca S, Funk M, Carta MG. Evaluating the efficacy of the WHO QualityRights e-training in promoting the rights of persons with mental health conditions and psychosocial disabilities: a cluster randomised controlled trial in Ghana. BMJ Glob Health. 2025 Dec 9;10(12):e021215. doi: 10.1136/bmjgh-2025-021215.
- Individual participant dataSharing planned: Yes. A coded dataset, with no confidential information, will be shared with researchers at Columbia University for data analysis collaboration
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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.
Maria Francesca Moro, M.D. principal investigator
Columbia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHO QualityRights e-training and WHO COVID-19 online training in people with Knowledge and Attitudes, run by Mental Health Society of Ghana at 3 sites in Ghana.
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 2 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ghana. 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. Some participants in this study may receive a placebo. 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?
Change from Baseline knowledge about human rights of persons with psychosocial disabilities post-training (time frame: pre-training, immediately post-training). The study lists 2 primary outcomes in all. 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 NCT04728243, which also lists 1 linked publication.
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 15 Feb 2023.