Plain English Summary
Background and study aims
Mental health problems have increased among young adults in Sweden the recent years. In 2016, half of women and a third of men between the ages 16-29 reported that they frequently experienced worry, stress, anxiety or sleeping problems. An innovative mobile phone-based program aims to enhance well-being among young adults. This study aims to investigate the effect of the new mobile phone-based program on mental health outcomes among young adults, and to investigate potential mediators (positive emotions, thoughts and behaviors).
Who can participate?
Students (healthy volunteers) over 18 years of age
What does the study involve?
Participants are randomly allocated to either an intervention (mobile-phone based program) or control group. The intervention aims to increase users’ positive mental health through automatic text messages that are sent to users throughout the program with on average one text message a day. The program runs for 10 weeks. The effect of the program on primarily well-being but also depression and anxiety symptoms is measured at the start of the study and at 3- 6- and 12 months follow-up.
What are the possible benefits and risks of participating?
Possible benefits could be an increase in wellbeing if the intervention turns out to be effective. No significant risks are foreseen. The study aims to recruit healthy volunteers and the intervention is preventative aiming to promote mental health. Participants signing up to the study hoping to gain access to the intervention but allocated to the control group could experience negative emotions. The invitation text therefore gives details about the study design to inform participants at an early stage that they may not be given access to the intervention.
Where is the study run from?
It is run by a research group based at Linköping University but universities throughout Sweden will be invited to take part.
When is the study starting and how long is it expected to run for?
October 2018 to April 2020
Who is funding the study?
Linköping University (Sweden)
Who is the main contact?
Dr Kristin Thomas
Trial website
Contact information
Type
Public
Primary contact
Dr Kristin Thomas
ORCID ID
http://orcid.org/0000-0001-6434-4855
Contact details
Faculty of Medicine and Health Sciences
Department of Medical and Health Sciences
Linköping University
Linköping
58183
Sweden
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Dnr 2018/5-31
Study information
Scientific title
How can we promote positive mental health among young adults in Sweden? An evaluation of a new mobile phone-based intervention
Acronym
Study hypothesis
The intervention group will increase their positive mental health significantly more compared to the control group.
Ethics approval
The regional ethical review board, Linköping University, 17/04/2018, ref: 2018/5-31
Study design
Two-arm randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
Positive mental health
Intervention
Participants will be randomized to either the intervention or control group. Each participant will be allocated a number 1 or 2 with equal probabilities using Java’s built-in random number generator (java.util.Random). Randomization is thus fully computerized, does not use any strata or blocks, and is not possible to subvert, because this and all subsequent study processes are fully automated.
Intervention group
The intervention is a mobile phone based intervention that aims to increase participants' positive mental health. The text messages include text and/or links to pictures, interactive exercises and further reading. Text messages are automatically sent to users throughout the program with on average 1 text message a day. The program runs for ten weeks with a new theme being introduced each week. These themes have been shown to be important for our positive mental health and include e.g. practicing gratitude or identifying personal strengths.
Control group
The control group will be given contact details of their local Student health services and Primary care center in a text message after randomization. The Student health services in Sweden are responsible for mental health promotion among university students.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Positive mental health, measured using the Mental health Continuum-Short Form at baseline, 3 months, 6 months and 12 months
Secondary outcome measures
Depression and anxiety symptomatology, measured using the Hospital Anxiety Depression Scale at baseline, 3 months, 6 months and 12 months
Overall trial start date
01/10/2018
Overall trial end date
01/04/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. University students between the ages of 18-29 years of age
2. Able to read and understand Swedish
3. Own a mobile phone
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
A total of 503 participants
Participant exclusion criteria
1. High score on the Mental Health Continuum – Short Form defined as a self-rated score above 70 (maximum score 84)
2. Mild depressive or anxiety symptomatology defined as a score of 10 and above on either subscale on the Hospital Anxiety Depression Scale
Recruitment start date
01/10/2018
Recruitment end date
01/04/2019
Locations
Countries of recruitment
Sweden
Trial participating centre
Linköping University
Insitutionen för Medicin och Hälsa
Linköping
58183
Sweden
Sponsor information
Organisation
Linköping University
Sponsor details
Faculty of Medicine and Health Sciences
Department of Medical and Health Sciences
Linköping
58183
Sweden
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Linköpings Universitet
Alternative name(s)
Linköping University, LiU
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Sweden
Results and Publications
Publication and dissemination plan
Additional documents (study protocol including statistical analysis plan) will be available but not yet published. Planned publication of the results in a high-impact peer reviewed journal during the first quarter of 2020.
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to the General Data Protection Regulation and recommendations from our regional Ethical Committee.
Intention to publish date
01/03/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/31418426 (added 19/08/2019)