Clinical trial NCT06484205: Evaluation of the Effectiveness of the World Health Organization QualityRights Training in Italy
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver Burden
Keywords: psychosocial disabilities
caregivers
online training
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Randomized controlled clinical trial with four evaluation times (T0 pre- treatment; T1 post treatment; T2 3 months after T1 and T2 6 months after T1; aimed at evaluating the effectiveness of the World Health Organization QualityRights training compared to a control intervention (another online training program) in improving caregivers' human rights knowledge and attitudes towards people with psychosocial disabilities as rights holders.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improving the knowledge about human rights and the attitudes of caregivers towards people with psychosocial disabilities
timeFrame: T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)
Secondary outcomes:
measure: Change from Baseline to post intervention and to follow-ups of The Short Form Health Survey (Quality of life)
timeFrame: T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)
measure: Change from Baseline to post intervention and to follow-ups of Patient Health Questionnaire-9 (Depressive symptoms)
timeFrame: T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)
measure: Change from Baseline to post intervention and to follow-ups of Zarit Burden interview
timeFrame: T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Azienda Ospedaliero Universitaria Cagliari
Study officials:
References: