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NCT Number: NCT06484205

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria Cagliari

Cagliari, 09100, Italy

Location status: Recruiting

Location contact

Carta

CONTACT

Maria F Moro, MD

SUB_INVESTIGATOR

Mauro G Carta, MD

CONTACT

[email protected]

070 51092158

Michela Atzeni

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WHO QualityRights e-training

Other

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.

Emotional intelligence e-training

Other

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

Primary outcomes

  1. Improving the knowledge about human rights and the attitudes of caregivers towards people with psychosocial disabilities

    Time frame: T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)

    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.

Secondary outcomes

  1. Change from Baseline to post intervention and to follow-ups of The Short Form Health Survey (Quality of life)

    Time frame: T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)

    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

  2. Change from Baseline to post intervention and to follow-ups of Patient Health Questionnaire-9 (Depressive symptoms)

    Time frame: T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)

    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.

  3. Change from Baseline to post intervention and to follow-ups of Zarit Burden interview

    Time frame: T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mauro G Carta, Md

CONTACT

[email protected]

070 51092158

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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