Condition category
Mental and Behavioural Disorders
Date applied
10/09/2018
Date assigned
28/09/2018
Last edited
28/09/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

www.liu.se

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

Publication citations

Additional files

Editorial Notes