How can we promote positive mental health among young adults in Sweden? An evaluation of a new mobile phone-based intervention
| ISRCTN | ISRCTN54748632 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54748632 |
| Secondary identifying numbers | Dnr 2018/5-31 |
- Submission date
- 10/09/2018
- Registration date
- 28/09/2018
- Last edited
- 23/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Public
Faculty of Medicine and Health Sciences
Department of Medical and Health Sciences
Linköping University
Linköping
58183
Sweden
 ORCID ID |
0000-0001-6434-4855 |
|---|
Study information
| Study design | Two-arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Scientific title | How can we promote positive mental health among young adults in Sweden? An evaluation of a new mobile phone-based intervention |
| Study objectives | The intervention group will increase their positive mental health significantly more compared to the control group. |
| Ethics approval(s) | The regional ethical review board, Linköping University, 17/04/2018, ref: 2018/5-31 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2018 |
| Completion date | 01/04/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 29 Years |
| Sex | Both |
| Target number of participants | A total of 503 participants |
| Total final enrolment | 654 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2018 |
| Date of final enrolment | 01/04/2019 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Linköping
58183
Sweden
Sponsor information
University/education
Faculty of Medicine and Health Sciences
Department of Medical and Health Sciences
Linköping
58183
Sweden
| Website | www.liu.se |
|---|---|
"ROR" |
https://ror.org/05ynxx418 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Linköping University, Linköping University, LiU
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/08/2019 | 19/08/2019 | Yes | No |
| Results article | results | 20/03/2020 | 23/03/2020 | Yes | No |
Editorial Notes
23/03/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
19/08/2019: Publication reference added.
