NCT04728243

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

August 11, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

January 20, 2021

Last Update Submit

February 14, 2023

Conditions

KnowledgeAttitudesPractices

Keywords

mental healthhuman rightsRCTGhanaonline training

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    pre-training, immediately post-training

Secondary Outcomes (4)

  • Change from Baseline Practices related to substitute-decision making and coercion scale at 3 months

    pre-training, at 3 months

  • Change from Baseline Seclusion and Restraint Experience post-training

    pre-training, immediately post-training

  • Change from Baseline Burnout at 3 months

    pre-training, at 3 months

  • Change from Baseline Quality of Life at 3 months

    pre-training, at 3 months

Other Outcomes (7)

  • Change from Baseline knowledge about human rights of persons with psychosocial disabilities at 3 months

    pre-training, at 3 months

  • Change from Baseline knowledge about human rights of persons with psychosocial disabilities at 6 months

    pre-training, at 6 months

  • Change from Baseline attitudes towards persons with psychosocial disabilities role as rights-holders at 3 months

    pre-training, at 3 months

  • +4 more other outcomes

Study Arms (2)

WHO QualityRights

EXPERIMENTAL

Mental health professionals assigned to the experimental arm will be enrolled in the WHO QualityRights online training.

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.

Other: WHO COVID-19 online training

Interventions

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 QualityRights
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.

WHO Coronavirus Disease of 2019 (COVID19)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Persons who participated to the in-person WHO QualityRights trainings held in Ghana.
  • Persons enrolled in the online WHO QualityRights training. .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ankaful Psychiatric Hospital

Cape Coast, Central Region, Ghana

Location

Accra Psychiatric Hospital

Accra, Ghana

Location

Pantang Psychiatric Hospital

Accra, Ghana

Location

Related Publications (1)

  • 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.

    PMID: 41365627DERIVED

MeSH Terms

Conditions

BehaviorPsychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction

Study Officials

  • Maria Francesca Moro, M.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and Researcher

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 28, 2021

Study Start

August 11, 2021

Primary Completion

July 19, 2022

Study Completion

January 19, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

A coded dataset, with no confidential information, will be shared with researchers at Columbia University for data analysis collaboration

Shared Documents
STUDY PROTOCOL, CSR, ANALYTIC CODE
Time Frame
to be decided
Access Criteria
to be decided - the access criteria will guarantee the respect of confidentiality in agreement with General Data Protection Regulation (GDPR) and HIPAA requirements

Locations

GH(3)