Digital mental health literacy program for first-year medical students in Finland

ISRCTN	ISRCTN10565335
DOI	https://doi.org/10.1186/ISRCTN10565335
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Academy of Finland
Funder	Academy of Finland

Submission date: 12/05/2021
Registration date: 26/05/2021
Last edited: 10/11/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Medical students are prone to mental disorders such as depression and anxiety. The psychological burden is mainly related to the high demands of the studies. There is a need to implement interventions that improve medical students’ mental health literacy and wellbeing. This study aims to investigate the impact of a digital mental health literacy program Transitions with blended life skill and mindfulness components among first-year medical students.

Who can participate?
First-year medical students.

What does the study involve?
The student will have to register in the digital program platform in order to participate in the study. The program involves two lectures and independent learning of the digital material in between the lectures. The data are collected from the participants using electronic questionnaires three times in total: before the program starts (baseline), immediately after completing the program and 2 months after the baseline.

What are the possible benefits and risks of participating?
The students' knowledge about mental health may increase, their attitudes towards mental health can become more positive and their help-seeking behavior may be enhanced. The study may also strengthen the students' stress management skills and alleviate emotional (mainly anxiety and stress) symptoms. A data processing impact assessment has been conducted, and data protection matters have been carefully considered and both technical and organizational protective measures have been undertaken. Risks related to data protection are minimal and other risks have not been identified in the study.

Where is the study run from?
University of Turku (Finland)

When is the study starting and how long is it expected to run for?
From March 2017 to February 2020

Who is funding the study?
The Academy of Finland (Finland)

Who is the main contact?
Dr. Marjo Kurki, mhkurk@utu.fi

Contact information

Prof Andre Sourander
Scientific

Research center for child psychiatry
Lemminkäisenkatu 3 / Teutori 3rd floor
University of Turku
Turku
20014
Finland

ORCID ID	0000-0003-0361-7244
Phone	+358503653447
Email	andre.sourander@utu.fi

Study information

Primary study design	Interventional
Study design	One-group quasi-experimental design
Secondary study design	Pre-test - post-test, all participants receive the intervention.
Participant information sheet	ISRCTN10565335_PIS_Finnish_v1_18Apr2017.pdf
Scientific title	Digital mental health literacy -program for first-year medical students’ wellbeing: single-group quasi-experimental study
Study objectives	Digital Transitions will improve first-year medical students’ knowledge about mental health, decrease stigma associated with mental health problems, and improve help-seeking attitudes.
Ethics approval(s)	Approved 03/05/2017, Ethics Committee for Human Sciences at the University of Turku (FI-20014 University of Turku, Finland; eettinen@utu.fi; +358 50 303 0346), no ref
Health condition(s) or problem(s) studied	Prevention of mental health problems by increasing students' knowledge about mental health, improving their attitudes towards mental health problems, enhancing help-seeking behavior as well as promotion of wellbeing and stress management.
Intervention	The intervention consists of two in-person lectures lasting 60 min each, delivered by a mental health professional, and a digital self-learning material. The first lecture focuses on strategies for independent living and studying, while the second lecture focuses on mental health, and stress management and mental disorders, help-seeking, and treatment. In between the lectures, the students have approximately 4 weeks to learn the digital material. Participants were also encouraged to practice stress management skills, including mindfulness exercises at any time during the course. The digital transitions consisted of three themes addressing life skill resources and mental health topics. Theme 1 comprised of important skills for independent living and academic life strategies. Theme 2 comprised of strategies on how to obtain and maintain sound mental health, and stress management skills. Theme 3 comprised of mental disorders, related treatment and help-seeking.
Intervention type	Behavioural
Primary outcome measure(s)	Mental health literacy, which comprises the following aspects: 1. Knowledge about mental health measured using an adapted mental health literacy measurement instrument as electronic questionnaires that were embedded in the program platform at baseline (at the beginning of the first lecture), pre-intervention, 4 weeks (at the end of the second lecture), and 2 months 2. Attitudes towards mental health and help-seeking measured using at an adapted mental health literacy measurement instrument as electronic questionnaires that were embedded in the program platform baseline, 4 weeks, and 2 months 3. Help-seeking behaviour measured using an adapted mental health literacy measurement instrument as electronic questionnaires that were embedded in the program platform at baseline, 4 weeks, and 2 months
Key secondary outcome measure(s)	1. Perceived stress measured using the Perceived Stress Scale (PSS) at baseline, 4 weeks, and 2 months 2. Emotional health measured using the General Health Questionnaire-12 (GHQ-12) at baseline, 4 weeks, and 2 months
Completion date	15/02/2020

Eligibility

Participant type(s)	Other
Age group	Adult
Sex	All
Target sample size at registration	374
Total final enrolment	186
Key inclusion criteria	First-year medical student
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/09/2018
Date of final enrolment	30/08/2019

Locations

Countries of recruitment

Finland

Study participating centre

University of Turku

Teutori 3rd floor
Lemminkäisenkatu 3
Turku
20014
Finland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to data protection policies of University of Turku, Finland, and EU GDPR. The collected data include sensitive and identifiable data.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		06/11/2021	10/11/2021	Yes	No
Participant information sheet	version v1	18/04/2017	01/06/2021	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version v1	18/04/2017	01/06/2021	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN10565335_PROTOCOL_Finnish_v1_18Apr2017.pdf: Uploaded 01/06/2021
ISRCTN10565335_PIS_Finnish_v1_18Apr2017.pdf: Uploaded 01/06/2021

Editorial Notes

10/11/2021: Publication reference added.
01/06/2021: The following changes have been made:
1. Uploaded protocol version 1, 18 April 2017 (not peer reviewed).
2. The participant information sheet has been uploaded as an additional file.
26/05/2021: Trial’s existence confirmed by Ethics Committee for Human Sciences at the University of Turku.