NCT05639855

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
740

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 5, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

1.8 years

First QC Date

November 13, 2022

Last Update Submit

December 2, 2022

Conditions

Keywords

mental health disorderstigmauniversity studentsoccupational therapyalphabetisation

Outcome Measures

Primary Outcomes (3)

  • 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.

    One month pre-intervention and one month post-intervention

  • 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.

    One month pre-intervention and one month post-intervention

  • 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.

    within 1 month after the intervention

Secondary Outcomes (3)

  • Measurement of the Students of University of A Coruña attitudes and beliefs toward people with mental disorders

    within 1 month after the intervention

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

    within 1 month after the intervention

  • Individual-interviews

    within 1 month after the intervention

Study Arms (3)

Third year students of the Bachelor's Degree in Occupational Therapy

EXPERIMENTAL

Third-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.

Other: Mental Health Literacy Programme

Students of University of A Coruña

NO INTERVENTION

The 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 disorder

NO INTERVENTION

Users 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.

Interventions

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.

Third year students of the Bachelor's Degree in Occupational Therapy

Eligibility Criteria

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

You may qualify if:

  • Be graduated at Occupational Therapy Degree at the University of A Coruña

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nereida Canosa Domínguez

A Coruña, 15071, Spain

RECRUITING

Related Publications (10)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Mental DisordersSocial Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Nereida Canosa Domínguez, Master

    Universidade da Coruña

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nereida Canosa Domínguez, Master

CONTACT

Betania Groba González, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2022

First Posted

December 6, 2022

Study Start

September 5, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

December 6, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

The IPD sharing plan contains the collection of the variables of the present study.

Locations