Evaluation of the Effectiveness of the World Health Organization QualityRights Training in Italy

Promoting Human Rights in Mental Health: Evaluation of the Effectiveness of the World Health Organization QualityRights Training in Italy Among Caregivers of People With Psychosocial Disabilities

The research aims to promote human rights of people with psychosocial disabilities. The design will be a randomized controlled trial (RCT) with two groups. The intervention will consist of participation in an online training, with a central focus on the human rights of people with psychosocial disabilities. The measured outcomes will be knowledge of human rights, caregivers' attitudes towards people with psychosocial disabilities as rights holders, caregiver burden, depressive symptoms, and quality of life.

Study Overview

• Status: Recruiting
• Conditions: Caregiver Burden
• Intervention / Treatment: Other: WHO QualityRights e-training; Other: Emotional intelligence e-training

Detailed Description

Throughout the world, people with psychosocial disabilities are frequently exposed to human rights violations, such as discrimination and exclusion from society, inability to access health services, physical, sexual and psychological abuse, violence, neglect and denial of the right to legal capacity.

Another obstacle to access to care, to social inclusion and which encourages violations of the human rights of people with psychosocial disabilities is represented by the stigma and discrimination it entails.

Furthermore, caregivers themselves can also be the recipients of stigma, and previous research suggests it affects more than half of them.

This stigmatization represents a real burden, especially in emotional terms, for caregivers and can reduce access to support, resources and opportunities in the social sphere with an impact that also has repercussions on the person with psychosocial disabilities for whom they take care. treatment.

The importance of providing positive support to caregivers in their supporting role emerges; an increasingly broad evidence base underlines the benefits of caregiver involvement on the well-being of their family member, in particular it is associated with an improvement in the quality of life, a reduction in symptoms, the risk of relapses and hospital admissions.

In this context, Internet-based interventions can be a useful tool to increase the knowledge of caregivers of people with psychosocial disabilities and to reduce the physical and psychological consequences resulting from burden and stigma.

The implementation of a mental health human rights literacy intervention among caregivers is of crucial importance in the current context. This type of initiative aims to provide caregivers with the knowledge and skills needed to understand, respect, defend and promote the human rights of people with psychosocial disabilities and can help caregivers identify situations where the rights of people with psychosocial disabilities could be violated. Such action can contribute to the empowerment of caregivers and people with mental health conditions and can help combat the stigma and discrimination associated with mental disorders.

The specific objective of the research is to conduct a randomized controlled trial in Italy to evaluate the effectiveness of the World Health Organization QualityRights training compared to a control intervention (another online training program) in improving human rights knowledge and caregivers' attitudes towards people with psychosocial disabilities as rights holders.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mauro G Carta, MD; Phone Number: 070 51092158; Email: maurogcarta@gmail.com

Study Locations

• Italy
  • Cagliari, Italy, 09100
    • Recruiting
    • Azienda Ospedaliero Universitaria Cagliari
    • Contact: Mauro G Carta, MD; Phone Number: 070 51092158; Email: maurogcarta@gmail.com
    • Contact: Carta
    • Sub-Investigator: Maria F Moro, MD
    • Sub-Investigator: Michela Atzeni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• people aged 18 or over;
• caregivers of people with psychosocial disabilities relating to local mental health services;
• italian speaking people

Exclusion Criteria:

• individuals under 18 years of age;
• people who have already participated in the WHO QualityRights online course.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WHO QualityRights e-training; Participants assigned to the intervention group (n 40) will participate in the WHO QualityRights (QR) online training course on "Mental Health, Recovery and Community Inclusion". The QR training aims to increase knowledge of the rights of people with psychosocial disabilities and to change negative attitudes towards them and their role as rights holders.	Other: WHO QualityRights e-training; WHO QualityRights training provides the necessary skills to support people with psychosocial disabilities in advocating for their rights. The QualityRights online course includes six main modules: 1) Human Rights; 2) Human rights, mental health and disability; 3) Legal capacity and the right to decide; 4) Stop coercion, violence and mistreatment; 5) Quality services and inclusion in the community; 6) Mental health, well-being and recovery and it will take approximately 8 hours for completion. QualityRights course modules can be completed at each participant's pace and needs. The training is considered concluded once the quizzes provided at the end of each of the six modules have been successfully completed and upon completion of the course it will be possible to download your official WHO certificate from the QR platform.
Active Comparator: Emotional intelligence e-training; Participants assigned to the control group (n 40) will receive the online "Emotional Intelligence Training for Informal Caregivers" offered by PeerCare.	Other: Emotional intelligence e-training; This course offers caregivers resources and knowledge so that they are able to manage their emotions and gain quality in the care they provide to others and in their own lives. The course duration is similar to that of the QualityRights online course and is intended for caregivers of people with disabilities and others interested

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improving the knowledge about human rights and the attitudes of caregivers towards people with psychosocial disabilities	To evaluate it will be used: the World Health Organization's Knowledge about the Rights of persons with psychosocial disabilities questionnaire (16 items). It was developed by World Health Organization (WHO) to assess knowledge about the rights included in the United Nations Convention on the Rights of Persons with Disabilities (UN CRPD), and The World Health Organization's questionnaire on the attitudes towards people with psychosocial disabilities as rights-holders (17 items). It was developed by WHO and includes three sub-scales: attitudes towards institutionalization and living independently in the community; attitudes toward mandatory treatment and coercion; attitudes toward people with psychosocial disabilities as decision-makers.	T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to post intervention and to follow-ups of The Short Form Health Survey (Quality of life)	To evaluate it will be used: The Short Form Health Survey (SF-12), a brief version of SF-36 questionnaire, made up of twelve questions, values range from 12 to 47, includes the following dimensions: physical activity, disturbance in physical health, physical condition, self-assessment of health status, vitality, social activity and mental health assessed on a monthly basis . Higher scores recorded a greeting and better Quality of life	T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)
Change from Baseline to post intervention and to follow-ups of Patient Health Questionnaire-9 (Depressive symptoms)	To evaluate it will be used: Patient Health Questionnaire-9 (PHQ-9) a short self-administered tool, values range from 0 to 27, used for screening, diagnosis, monitoring and measuring the severity of depression. It's composed of 9 items that correspond to the symptoms of major depression according to Diagnostic and statistical manual of mental disorders (DSM-IV) on last two weeks. Higher scores identify a greater presence of depressive symptoms.	T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)
Change from Baseline to post intervention and to follow-ups of Zarit Burden interview	To evaluate it will be used: The Zarit Burden interview, a questionnaire for assessing the consequences that the care burden of a family member with chronic disabilities has on the caregiver. It is a self-assessment tool made up of 22 items with responses rated on a 5-point Likert scale: from 0 (never) to 4 (almost always) based on the degree of agreement with the individual items. The items investigate how the patient's disability impacts the caregiver's quality of life, psychological suffering, sense of guilt, financial difficulties, shame and social and family difficulties.	T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)

Collaborators and Investigators

• Sponsor: University of Cagliari

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2024
• Primary Completion (Estimated): June 26, 2025
• Study Completion (Estimated): December 6, 2025

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: caregivers; online training; psychosocial disabilities
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: Verbale n39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No