Condition category
Mental and Behavioural Disorders
Date applied
22/08/2019
Date assigned
13/11/2019
Last edited
13/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Depression is the most significant contributor to non-fatal health loss, with 7.5% of all Years Lived with Disability. In Portugal, depression ranks the 4th highest yearly prevalence (7.9%) within the 34 countries taking part in the World Health Organization Survey, and it also presents a huge treatment gap. The transition phase experienced by young people at the beginning of university attendance represents a high-risk moment for depression, and timely intervention in this population group is of the highest importance. The well-recognized negative consequences of mental health stigma have contributed to the notable increase in the number of stigma reduction interventions. However, there is still a lack of research concerning the effectiveness of these interventions. The aim of this study is to find out whether a video-based intervention can reduce the stigma associated with depression in first-year university students.

Who can participate?
First‐year students

What does the study involve?
Participants are randomly allocated to the control group or one of two intervention groups. The control group receive no intervention. The intervention groups are asked to watch a short video about depression. A different video is assigned to each of the intervention groups. The video contains people sharing their personal experiences of depression, used as a video-based contact intervention, subtitled by the team members. The video used for intervention group 2 is composed of the first video plus a psychoeducational information short video.

What are the possible benefits and risks of participating?
Benefits include increasing our knowledge about how to reduce the stigma associated with depression, as well as on the processes underlying the relationship between stigma and help-seeking behaviours. Possible risks/inconvenience include the time invested in responding to the questionnaires as well as watching the intervention videos.

Where is the study run from?
Institute of Public Health of the University of Porto (Portugal)

When is the study starting and how long is it expected to run for?
February 2019 to November 2019

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Virgínia Conceição
up200501131@med.up.pt

Trial website

Contact information

Type

Scientific

Primary contact

Miss Virgínia Conceição

ORCID ID

http://orcid.org/0000-0002-3281-1508

Contact details

Rua Domingos Machado
102
Porto
4250-201
Portugal
+351 (0)912969687
up200501131@med.up.pt

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PMHDS

Study information

Scientific title

Mental health stigma: a video‐based randomized controlled trial to reduce depression stigma among university students

Acronym

Study hypothesis

Video‐based contact intervention reduces depression stigma among first‐year university students.

Ethics approval

Approved 26/12/2018, Institute of Public Health of the University of Porto ethics committee (Rua das Taipas 135, 4050-091 Porto; Tel: +351 (0)222061820; Email: etica@ispup.up.pt), ref: CE18096

Study design

Single‐center single‐blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

The stigma associated with depression

Intervention

All participants will be randomly distributed among one control group and two intervention groups. Participants are numbered in an ordinal manner, and numbers will be randomized using a randomization software online. Intervention groups will be asked to watch a short video about depression. A different video will be assigned to each of the intervention groups.

For the purpose of the intervention, an assessment of the available videos about depression stigma was conducted, and the videos were analyzed taking in account the type of content, its length and socio-demographic aspects of the video participants. The first phase of the decision making was based on what is already known about video-based interventions on mental health stigma, resulting in a total of five potential videos. In the second phase, the videos were analyzed by two independent researchers that selected only two of them. In the third and last phase of the process, the researchers met and agreed on the final video for intervention group 01: a 3 minutes and 29 seconds long video was selected. The video, developed by BBC Three and available on YouTube, contains people sharing their personal experiences of depression, used as a video-based contact intervention, subtitled by the team members. The video used on the intervention group 2 is composed of the first video plus a psychoeducational information short video developed by EAAD, the European Alliance Against Depression (www.eaad.net) and EUTIMIA (www.eutimia.pt), the Portuguese branch of EAAD.

No intervention will be applied to the control group.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Percentage of depression stigma will be measured by the Depression Stigma Scale, developed in Australia and used in a number of community samples. The scale distinguishes between personal and perceived stigma and each subscale is constituted by 9 five‐point Likert scale items. The Portuguese version was translated and adapted by Eutimia (European Alliance Against Depression in Portugal).
Measured 30 days before the intervention, immediately after the intervention, and 3 months after the intervention

Secondary outcome measures

Measured 30 days before the intervention, immediately after the intervention, and 3 months after the intervention:
1. Anxiety stigma, measured by the Generalised Anxiety Stigma Scale
2. Help-seeking behaviour measured by the Attitudes Toward Seeking Professional Help
3. Depression monitoring measured by The Patient Health Questionnaire
4. The Generalized Anxiety Disorder measured by the Generalized Anxiety Disorder

Overall trial start date

01/02/2019

Overall trial end date

30/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All first‐year students will be contacted through institutional email and will be asked to answer the questionnaire. After gathering the pre‐test answers, all respondents will be included in the study.

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

1200

Participant exclusion criteria

Not responding to the Depression Stigma Scale

Recruitment start date

01/04/2019

Recruitment end date

31/05/2019

Locations

Countries of recruitment

Portugal

Trial participating centre

Institute of Public Health of the University of Porto
Rua das Taipas nº135
Porto
4050-600
Portugal

Sponsor information

Organisation

Institute of Public Health of the University of Porto

Sponsor details

Rua das Taipas
nº 135
Porto
4050-600
Portugal
+351 (0)222 061 820
secretaria@ispup.up.pt

Sponsor type

University/education

Website

http://ispup.up.pt/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers plan to publish the study protocol in a peer-reviewed journal.

The researchers are planning to publish three results papers:
1. Depression and anxiety stigma predictors among first-year university students and its effect on help-seeking attitudes - to be published in January 2020
2. The effects of a video-based intervention on depression stigma reduction among first-year university students - to be published in February 2020
3. Depression stigma reduction intervention and help-seeking attitudes

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from rgusmão@mac.com (the researcher supervisor) and Virgínia da Conceição (up200501131@med.up.pt). As this study is part of a PhD research, the data will be available as soon as the PhD research is completed (end of 2020), and it can be requested in the 5 years subsequent to that time. Data will be available in SPSS, containing socio-demographic information (age, gender, living situation and previous diagnosis and mental health access care), and the dependent and independent variables of the study, previously described. To access the data, applicants must be associated with an academic institution and for research only. Informed consent was obtained from all the participants and no identifiable personal information was obtained, ensuring total anonymity.

Intention to publish date

01/02/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/10/2019: Trial's existence confirmed by ethics committee.