How can I influence my future? A study of using an app to strengthen mental health among young adults who are not in education or employment
| ISRCTN | ISRCTN46697028 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46697028 |
- Submission date
- 15/01/2021
- Registration date
- 12/02/2021
- Last edited
- 27/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
There are many causes to why youths and young adults have difficulties completing studies, pursue further studies or enter working life. Unemployment and interrupted studies can both be a consequence of, and lead to, mental ill-health among young adults.
The aim of the study is to examine whether an app to promote mental wellbeing can strengthen the ability of young adults who are not in education or employment to increase mental skills and capacities in order to gain employment, work experience placement or restart education.
Who can participate?
Young adults in the ages of 16-24 years who are not in education or employment.
What does the study involve?
The participants, 180 young adults in the ages of 16-24 years, will be randomly divided into two groups - intervention and control - by using simple randomization with computer-generated random numbers. The intervention group will be using an app for 6 weeks. The exercises in the app are based on 6 themes – self-esteem, stress, acceptance, relations, problem solving and life goals – and are designed to support the young adults to think in new ways and to get to know themselves and their feelings better. They will also share their thoughts and hear others’ during weekly digital group meetings. The control group will receive film clips once a week for 6 weeks.
Data from the participants will be collected via self-administered questionnaires at three-time points: before randomization and 8 weeks and 6 months after randomization. The questionnaire includes questions about their background and life situation followed by validated questions regarding their feelings and thoughts and their views on how they cope with those. Their replies will provide more knowledge of how mental skills and abilities are influenced by the use of the app. If the app is shown to be effective for young adults who are not in employment or education, it has good potential to be spread widely and could provide a valuable tool to reach a population that has a great need but who are many times difficult to reach.
What are the possible benefits and risks of participating?
The target group for the intervention is a very heterogeneous one but many of the young adults who are neither in employment nor in education are in a vulnerable situation and mental ill-health is widespread. Starting to think more in-depth about how one feels can initially be difficult, but the hope is that the intervention will strengthen the mental health of the participants which, in the longer run, could increase their chances for employment or future studies.
Where is the study run from?
Karolinska Institutet, Department of Global Public Health (Sweden)
When is the study starting and how long is it expected to run for?
March 2019 to August 2022
Who is funding the study?
Forskningsrådet om hälsa, arbetsliv och välfärd (Swedish Research Council for Health, Working Life and Welfare, FORTE)
Who is the main contact?
Associate Professor Lene Lindberg, lene.lindberg@ki.se
Dr Lisa Blom, lisa.blom@ki.se
Contact information
Scientific
Prevention, Intervention and Mechanisms in Public Health (PRIME Health) research group
Solnavägen 1E
Stockholm
113 65
Sweden
 ORCID ID |
0000-0002-3538-7159 |
|---|---|
| Phone | +46 (8) 524 832 93 |
| lisa.blom@ki.se |
Scientific
Prevention, Intervention and Mechanisms in Public Health (PRIME Health) research group
Solnavägen 1E
Stockholm
113 65
Sweden
| ORCID ID |
0000-0002-9275-551X |
|---|---|
| Phone | +46 (8) 123 371 18 |
| lene.lindberg@ki.se |
Study information
| Study design | Interventional two-armed randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | ISRCTN46697028_PIS.docx |
| Scientific title | How can I influence my future? A randomized controlled intervention study to strengthen mental health among young adults who are not in education or employment |
| Study objectives | 1. Does participation in an app-based psychological intervention program influence self-esteem, coping abilities, stress and well-being among young adults who are not in education, employment or training? 2. Does participation in an intervention of that kind influence the ability to gain employment or work experience placement among young adults who are not in education, employment or training? 3. Does participation in such a program influence the ability to go into further education among young adults who are not in education, employment or training? |
| Ethics approval(s) | Approved 24/11/2020, Swedish Ethical Review Authority (Box 2110, 750 02 Uppsala, Sweden; +46 (0) 10 475 08 00; registrator@etikprovning.se), ref. 2020-03952 |
| Health condition(s) or problem(s) studied | Mental health among young adults who are not in education or employment |
| Intervention | Participants will be assigned to either the intervention or the control group by using simple randomization with computer-generated random numbers. The intervention group will be invited to sign up for a youth version of the app 29k (https://29k.org/youths) consisting of 6 modules taken during 6 weeks with weekly compliance reminders sent out via email/sms. When registering in the app, participants will be asked a few questions and based on that, provided tailored propositions on how to use the app. The content of the 6 modules will focus on the following themes: self-compassion, stress, goal setting, problem solving, interpersonal skills and emotional regulation. The use of the app will include individual exercises, digital group meetings and a possibility to individual follow-ups. It is expected to take about 60 minutes per week of the participants in the intervention group. The control group will be sent links via push notifications through sms or emails to film clips once a week during 6 weeks. The films will be focusing on the same content as the modules in the intervention group. Participants will be asked to look at the films at a time of their convenience. It is expected to take in total 10-15 minutes per week. |
| Intervention type | Behavioural |
| Primary outcome measure | Collected through self-administered questionnaires at three time points: at baseline, directly after the intervention (8 weeks after randomization) and 6 months after randomization. 1. Coping measured by using a selection of 14 of the original 28 items from a Swedish version of the Brief COPE 2. Self-esteem measured with the Swedish version of the Rosenberg self-esteem scale 3. Well-being measured with the Swedish version of the 5-item World Health Organisation Well-Being Index (WHO5) 4. Performance anxiety measured with the Swedish version of the General Anxiety Disorder-7 (GAD-7) 5. Stress measured with the Swedish version of the Perceived Stress Scale (PSS10) 6. Career adapt-abilities will be measured with a translated version of the Career Adapt-Abilities Scale Short form 7. Depression will be measured with the Swedish version of the Patient Health Questionnaire (PHQ-9) |
| Secondary outcome measures | Collected at time point 2 and 3 (T2 and T3), i.e. at 8 weeks and at 6 months after randomization: 1. Employment status measured by asking questions regarding current employment or work experience placement 2. Education status will be measured with questions regarding if they are currently studying or have applied for studies 3. Questions regarding their perception whether the program has affected their motivation, goal setting and sustainable behaviours will also be asked at T2 and T3 |
| Overall study start date | 31/03/2019 |
| Completion date | 15/08/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 180 |
| Total final enrolment | 151 |
| Key inclusion criteria | 1. Adolescents and young adults in the ages of 16 - 24 years 2. Unemployed and not in education or training for at least two months 3. Willingness and possibility to participate in the full program 4. Sufficient level of Swedish to take part in the intervention |
| Key exclusion criteria | High values on screening for depression and/or symptoms of suicidal ideation. Screening will be done by using the Patient Health Questionnaire (PHQ9). In the case of values of 15 points or more, the individual will be referred to health care and provided contact details on where to seek care. |
| Date of first enrolment | 15/02/2021 |
| Date of final enrolment | 22/10/2021 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Birger Jarlsgatan 57C
Stockholm
113 56
Sweden
Sponsor information
University/education
Nobels väg 6
Stockholm
171 77
Sweden
| Phone | +46 8 524 800 00 |
|---|---|
| info@ki.se | |
| Website | https://ki.se/ |
"ROR" |
https://ror.org/056d84691 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Swedish Research Council for Health, Working Life and Welfare, FORTE
- Location
- Sweden
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of the trial are planned to be published in scientific peer-reviewed journals with open access during 2022. The plan is also to present the results at national and international seminars and conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available in a de-identified format upon request from Lene Lindberg (lene.lindberg@ki.se) until end of the year 2027. Ethical permission is required. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 12/02/2021 | No | Yes |
Additional files
- ISRCTN46697028_PIS.docx
- uploaded 12/02/2021
Editorial Notes
27/12/2024: The intention to publish date was changed from 31/12/2024 to 31/12/2025.
11/01/2024: The overall study end date was changed from 31/12/2022 to 15/08/2022.
12/12/2023: The intention to publish date was changed from 31/12/2023 to 31/12/2024.
08/12/2022: The following changes were made to the trial record:
1. The intention to publish date was changed from 31/12/2022 to 31/12/2023.
2. The total final enrolment was added.
13/10/2021: The recruitment end date has been changed from 15/10/2021 to 22/10/2021.
15/06/2021: The recruitment end date has been changed from 30/06/2021 to 15/10/2021.
11/05/2021: The recruitment end date was changed from 31/05/2021 to 30/06/2021.
15/04/2021: Trial website added, the recruitment end date was changed from 15/04/2021 to 31/05/2021.
24/02/2021: Internal review.
12/02/2021: The participant information sheet was uploaded as an additional file.
19/01/2021: Trial’s existence confirmed by Swedish Ethical Review Authority (Etikprövningsmyndigheten)
