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Mental Health DisorderNCT05639855

Study on Mental Health-related Stigma

A study testing Mental Health Literacy Programme in people with Mental Health Disorder, run by Nereida Canosa Rodríguez at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Mental disorders are currently among the main causes of disability worldwide. For this reason, various national and international organisations include the promotion of mental health among their strategic actions, with special emphasis on the fight against stigma. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Mental Health Disorder
What is being tested?
Mental Health Literacy Programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
740 participants
Where
1 siteSpain
Study dates
5 Sep 2021to 30 Jun 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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Be graduated at Occupational Therapy Degree at the University of A Coruña
  • Student in the University of A Coruña
  • Have a mental disorder [according to the Diagnostic Manual Diagnostic Manual]
  • Be a user of the Psychosocial and Labor Rehabilitation Centers of the Health Area of A Coruña

Who cannot join

  • Have difficulties in understanding and/or communication
  • Not being enrolled in the Mental Health module of the Degree in Occupational Therapy
  • Have difficulties in understanding and/or communication
  • Have difficulties in understanding and/or communication
  • Be in a situation of legal incapacity.

Trial locations and contacts

1 site in 1 country.

Nereida Canosa Domínguez, Master contact

881015967 ext. 881015967

nereida.canosa@udc.es

Betania Groba González, PhD contact

881015870 ext. 5870

b.groba@udc.es

Spain1 site, 1 recruiting
  • Nereida Canosa Domínguez

    A Coruña, 15071

    Nereida Canosa Domínguez, 981 16 70 00 ext. 5906, nereida.canosa@udc.es

    Recruiting

Other trials in Spain

About this study

Official title: Study on Mental Health-related Stigma: Attitudes and Values of University Students Towards People With Mental Disorders

Mental disorders are currently among the main causes of disability worldwide. For this reason, various national and international organisations include the promotion of mental health among their strategic actions, with special emphasis on the fight against stigma. Evidence shows that stigma has a negative impact on the process of recovery and participation of people with mental disorders.

The general aim of this study is to find out about the attitudes of university students at the University of A Coruña towards people with mental disorders and specifically to intervene with students of the Bachelor's Degree in Occupational Therapy to assess whether taking part in a Mental Health Literacy Programme changes these attitudes.

Read the detailed description

In recent years, there has been a growing interest in developing and evaluating anti-stigma plans in the field of mental health. However, stigmatising, coercive or paternalistic attitudes persist in society and have a negative impact on the recovery process of people with mental illness.

The Mental Health Spain Confederation proposes tackling stigma through intersectional mental health literacy interventions that incorporate the gender perspective and are focused on the needs identified by people with mental disorders.

The New Mental Health Strategy of the National Health System (2021-2026) establishes the need to involve people and their families, as well as the different social agents in the fight against stigma, especially social and health professionals, as well as the media and educational personnel. The aim of this study is to understand the nature of stigma towards people with mental disorders. In order to do so, it is necessary to take into consideration the experiences and experiences of the people themselves in order to develop plans to promote mental health from a participatory and comprehensive perspective. Likewise, it is considered relevant to know the perceptions of future professionals from different areas of knowledge (students of the University of A Coruña), evaluating their attitudes and beliefs regarding mental health. Finally, the aim is to evaluate the impact of incorporating a specific module on mental health and stigmatisation. a specific module on mental health and stigma in the university curriculum of the students of the Occupational Therapy Degree.

This research has the following objectives: (1) find out the perception of people with mental disorders in relation to the social stigma of citizens and Health Science professionals; (2) find out how university students perceive people with mental health problems, and (3) evaluate the impact of incorporating a specific module on mental health and stigma in the university curriculum, specifically in the Bachelor's Degree in Occupational Therapy.

Being tested
Mental Health Literacy Programme
Keywords
mental health disorder, stigma, university students, occupational therapy, alphabetisation
Medical subject headings
Mental Disorders, Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mental Health Literacy ProgrammeOther

    Mental Health Literacy Program. This program is part of the training of third-year students of the occupational therapy degree at the University of A Coruña. We will follow a mixed method following a sequential explanatory design. The quantitative part corresponds to a quasi-experimental study, where a comparison will be made between the phase before and after the students take the program. The qualitative part will comprise a phenomenological study to collect the knowledge acquired by the students after taking the program.

Study groups in NCT05639855
Study groupRoleWhat they receive
Third year students of the Bachelor's Degree in Occupational TherapyExperimentalThird-year students of the Bachelor's Degree in Occupational Therapy will receive training on a specific module on mental health and stigma in the university curriculum.
Receives: Other: Mental Health Literacy Programme
Students of University of A CoruñaNo interventionThe students of the University of A Coruña will take part in an online survey to find out the attitudes and beliefs of future professionals from different areas of knowledge regarding mental health.
People with mental health disorderNo interventionUsers of a Psychosocial and Labor Rehabilitation Centers in the A Coruña Health Care Area will take part in interviews to find out their experiences regarding the attributions made towards them by citizens and health professionals.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes on the measurement of the students of third-year of occupational therapy bachelor's degree attitudes and beliefs toward people with mental disorders

    It is composed of 40 items, rated on a 5-point Likert scale, ranging from strongly agree to strongly disagree. The scale comprises 4 factors: authoritarianism, benevolence, social restraint, and mental health ideology in the community. Each factor contains 10 statements concerning opinions about the way people with mental disorder are treated. Five of the 10 items are expressed in the positive and the other 5 are worded in the negative. The score for each subscale results from adding the positive items together with the negative items, which are transformed into positive values, with the total score being the sum of all of them. The higher the score, the greater the agreement. The sum of each factor is analyzed with the mean and standard deviation.

    Measured: One month pre-intervention and one month post-intervention

  2. Changes on the measurement of stigmatizing attitudes towards people with mental health disorders in students of third-year of occupational therapy bachelor's degree

    It is a Likert-type scale with 27 items on the situation posed, grouped into 9 factors: responsibility, pity, anger, dangerousness, fear, help, coercion, segregation and avoidance. I sum the items of each factor, obtaining a minimum of 3 and a maximum of 27.

    Measured: One month pre-intervention and one month post-intervention

  3. Acquired knowledge in students of third-year of occupational therapy bachelor's degree who participated in the intervention programme

    The interview is the most used data collection technique in qualitative studies. In this study, a semi-structured interview will be used because it is flexible and dynamic. It's a beginning interview to know the knowledge acquired by the students.

    Measured: within 1 month after the intervention

Secondary outcomes (3)
  1. Measurement of the Students of University of A Coruña attitudes and beliefs toward people with mental disorders

    It is composed of 40 items, rated on a 5-point Likert scale, ranging from strongly agree to strongly disagree. The scale comprises 4 factors: authoritarianism, benevolence, social restraint and mental health ideology in the community. Each factor contains 10 statements concerning opinions about the way people with mental disorder are treated. Five of the 10 items are expressed in the positive and the other 5 are worded in the negative. The score for each subscale results from adding the positive items together with the negative items, which are transformed into positive values, with the total score being the sum of all of them.

    Measured: within 1 month after the intervention

  2. Measurement of stigmatizing attitudes towards people with mental health disorders of the Students of University of A Coruña

    It is a Likert-type scale with 27 items on the situation posed, grouped into 9 factors: responsibility, pity, anger, dangerousness, fear, help, coercion, segregation and avoidance. I sum the items of each factor, obtaining a minimum of 3 and a maximum of 27.

    Measured: within 1 month after the intervention

  3. Individual-interviews

    The interviews were about the experiences of people with mental disorders in relation to stigma. The following questions composed the interview: the definition of stigma, the influence of society on people with a mental health disorder, experiences about the barriers detected in daily life, and the behavior of the health providers that work with people with a mental health disorder.

    Measured: within 1 month after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2022
  2. Study start5 Sep 2021
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
740 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05639855
Sponsor's protocol ID
2021/028
Status last verified
Dec 2022
First submitted
13 Nov 2022
Last updated
6 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The IPD sharing plan contains the collection of the variables of the present study.

Publications

  • Hankir AK, Northall A, Zaman R. Stigma and mental health challenges in medical students. BMJ Case Rep. 2014 Sep 2;2014:bcr2014205226. doi: 10.1136/bcr-2014-205226.

    PubMed 25183806
  • Clement S, Schauman O, Graham T, Maggioni F, Evans-Lacko S, Bezborodovs N, Morgan C, Rusch N, Brown JS, Thornicroft G. What is the impact of mental health-related stigma on help-seeking? A systematic review of quantitative and qualitative studies. Psychol Med. 2015 Jan;45(1):11-27. doi: 10.1017/S0033291714000129. Epub 2014 Feb 26.

    PubMed 24569086
  • Corrigan PW, Mittal D, Reaves CM, Haynes TF, Han X, Morris S, Sullivan G. Mental health stigma and primary health care decisions. Psychiatry Res. 2014 Aug 15;218(1-2):35-8. doi: 10.1016/j.psychres.2014.04.028. Epub 2014 Apr 18.

    PubMed 24774076
  • Lanfredi M, Macis A, Ferrari C, Rillosi L, Ughi EC, Fanetti A, Younis N, Cadei L, Gallizioli C, Uggeri G, Rossi R. Effects of education and social contact on mental health-related stigma among high-school students. Psychiatry Res. 2019 Nov;281:112581. doi: 10.1016/j.psychres.2019.112581. Epub 2019 Sep 27.

    PubMed 31586833
  • Mejia-Lancheros C, Lachaud J, O'Campo P, Wiens K, Nisenbaum R, Wang R, Hwang SW, Stergiopoulos V. Trajectories and mental health-related predictors of perceived discrimination and stigma among homeless adults with mental illness. PLoS One. 2020 Feb 27;15(2):e0229385. doi: 10.1371/journal.pone.0229385. eCollection 2020.

    PubMed 32106225
  • Milin R, Kutcher S, Lewis SP, Walker S, Wei Y, Ferrill N, Armstrong MA. Impact of a Mental Health Curriculum on Knowledge and Stigma Among High School Students: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2016 May;55(5):383-391.e1. doi: 10.1016/j.jaac.2016.02.018. Epub 2016 Mar 8.

    PubMed 27126852
  • Mahmoudi H, Saffari M, Movahedi M, Sanaeinasab H, Rashidi-Jahan H, Pourgholami M, Poorebrahim A, Barshan J, Ghiami M, Khoshmanesh S, Potenza MN, Lin CY, Pakpour AH. A mediating role for mental health in associations between COVID-19-related self-stigma, PTSD, quality of life, and insomnia among patients recovered from COVID-19. Brain Behav. 2021 May;11(5):e02138. doi: 10.1002/brb3.2138. Epub 2021 Apr 3.

    PubMed 33811451
  • Adu J, Oudshoorn A, Anderson K, Marshall CA, Stuart H, Stanley M. Policies and Interventions to Reduce Familial Mental Illness Stigma: A Scoping Review of Empirical Literature. Issues Ment Health Nurs. 2021 Dec;42(12):1123-1137. doi: 10.1080/01612840.2021.1936710. Epub 2021 Jul 28.

    PubMed 34319817
  • Ma HI, Hsieh CE. An Anti-Stigma Course for Occupational Therapy Students in Taiwan: Development and Pilot Testing. Int J Environ Res Public Health. 2020 Aug 3;17(15):5599. doi: 10.3390/ijerph17155599.

    PubMed 32756448
  • Tomar N, Ghezzi MA, Brinkley-Rubinstein L, Wilson AB, Van Deinse TB, Burgin S, Cuddeback GS. Statewide mental health training for probation officers: improving knowledge and decreasing stigma. Health Justice. 2017 Nov 15;5(1):11. doi: 10.1186/s40352-017-0057-y.

    PubMed 29143153

Questions about this trial

What is this clinical trial studying?

A study testing Mental Health Literacy Programme in people with Mental Health Disorder, run by Nereida Canosa Rodríguez at 1 site in Spain.

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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nereida Canosa Domínguez, Master (881015967 ext. 881015967, nereida.canosa@udc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes on the measurement of the students of third-year of occupational therapy bachelor's degree attitudes and beliefs toward people with mental disorders (time frame: One month pre-intervention and one month post-intervention). The study lists 3 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 NCT05639855, which also lists 10 linked publications.

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 6 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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