Condition category
Mental and Behavioural Disorders
Date applied
03/08/2017
Date assigned
08/08/2017
Last edited
07/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Interventions to reduce stress include several elements from models of health behaviour change, such as motivation, self-efficacy, and planning processes. However, the effectiveness of these single components within comprehensive programs has not been addressed so far, but could give valuable insights for the development of future digital health behaviour change interventions. Just-in-time interventions provided via mobile devices (i.e., text messages) are intended to help people to make healthy decisions “in the moment”, and thus have a near-future impact. Implementation intentions (i.e. if-then-plans) are a promising intervention component within digital interventions to reduce stress at the workplace. However, the effectiveness of this single element within a comprehensive life skills program has not been addressed so far, but could give valuable insights for the development of future interventions. The aim of this study is to test the impact of such just-in-time delivered interventions on stress reduction at the workplace among apprentices.

Who can participate?
Adolescents aged 16 or over who attend vocational training and feel stressed at workplace

What does the study involve?
On six working days, 1 hour before apprentices are on their way to work, participants are randomly allocated to receive either an intervention or no intervention. The intervention includes two text messages: one text message where they choose one of two predetermined if-then plans to reduce stress at the workplace, and another text message prompt to visualize the chosen plan. Perceived stress at the workplace is assessed 11 hours later in both groups.

What are the possible benefits and risks of participating?
Stress may be lower after receiving the stress-reducing text message. No risks of participation are expected.

Where is the study run from?
1. Swiss Research Institute for Public Health and Addiction (Switzerland)
2. University of Zurich, Applied Social and Health Psychology (Switzerland)

When is the study starting and how long is it expected to run for?
August 2017 to December 2018

Who is funding the study?
1. Swiss Research Institute for Public Health and Addiction (Switzerland)
2. University of Zurich, Applied Social and Health Psychology (Switzerland)

Who is the main contact?
Dr Theda Radtke
theda.radtke@psychologie.uzh.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Theda Radtke

ORCID ID

http://orcid.org/0000-0003-1228-1834

Contact details

Binzmühlestr.14/14
Zurich
8050
Switzerland
+41 (0)44 635 72 55
Theda.Radtke@uzh.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16.6.2

Study information

Scientific title

Efficacy of a just-in-time delivered planning intervention to reduce stress at the workplace among apprentices: a micro-randomized controlled trial

Acronym

MRCT Stress

Study hypothesis

1. On days adolescents receive the just-in time delivered planning intervention, adolescents report lower levels of stress during vocational training compared to days without the just-in time delivered planning intervention
2. Adolescents with higher levels of work-related vigor will benefit from just-in-time delivered planning intervention to a higher degree compared to adolescents with lower levels of work-related vigor
3. Adolescents with higher levels of work-related exhaustion will benefit from just-in-time delivered planning intervention to a higher degree compared to adolescents with lower levels of work-related exhaustion

Ethics approval

Ethics committee of the Faculty of Philosophy at the University of Zurich, 26/09/2016, ref: 16.6.2

Study design

Micro-randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Stress

Intervention

Participants receive the just-in-time delivered planning intervention to reduce stress on their typically indicated most stressful working day (or a randomly chosen working day in case no most stressful day can be identified) during a week. The intervention is delivered 1 hour before apprentices are on their way to work. In case of shift work the intervention is delivered at 6am. The study has an AB/BA crossover design, in which each participant receives the intervention and the control in a randomized order. The randomization sequence will be created using computerized random numbers. There is a period of at least 2 weeks between the intervention and control.

Intervention points in time include:
1. Assessment of state of receptivity via SMS text message question (“Are you working today?”) on one of their typically indicated working days, one hour before apprentices are on their way to work (or at 6am).
2. Confirmation of receptivity by a text message reply (“Yes”) from the participant.
3. The digital micro intervention where participants can choose one of two predetermined if-then plans to reduce stress at the workplace via SMS text messaging and another text message prompt to visualize the chosen plan.

Control points in time only include 1 and 2.

Follow-up assessments will be conducted in both intervention and control points in time 11 hours after the assessment of state of receptivity and the random allocation to one of the two intervention conditions.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Perceived stress at the workplace, assessed with one item measure 11 hours after the assessment of state of receptivity and the random allocation to one of the two intervention conditions

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/05/2017

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ownership of a mobile phone
2. A perceived stress level at the workplace that is above 3, measured on a Likert scale ranging from 1 (not stressful) to 5 (extremely stressful)
3. Aged 16 or over

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

130 per condition (including a dropout rate of 30%)

Participant exclusion criteria

1. A perceived stress level at the workplace that is below 3, measured on a Likert scale ranging from 1 (not stressful) to 5 (extremely stressful)
2. Age < 16
3. No vocational training at intervention day

Recruitment start date

09/08/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Switzerland

Trial participating centre

Swiss Research Institute for Public Health and Addiction
Konradstrasse 32
Zurich
8031
Switzerland

Sponsor information

Organisation

Swiss Research Institute for Public Health and Addiction

Sponsor details

Konradstrasse 32
Zurich
8031
Switzerland
+41 (0)44 448 11 74
severin.haug@isgf.uzh.ch

Sponsor type

University/education

Website

www.isgf.ch

Organisation

University of Zurich

Sponsor details

Applied Social and Health Psychology
Binzmühlestr.14/14
Zurich
8050
Switzerland
+41 (0)44 635 72 55
theda.radtke@uzh.ch

Sponsor type

University/education

Website

http://www.psychologie.uzh.ch/de/fachrichtungen/angsoz.html

Funders

Funder type

University/education

Funder name

Swiss Research Institute for Public Health and Addiction

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Universität Zürich

Alternative name(s)

University of Zurich, UZH

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Switzerland

Results and Publications

Publication and dissemination plan

Planned publication in a psychological or medical peer reviewed journal around one year after the overall trial end date. No other documents will be available.

IPD sharing statement
The datasets generated during and/or analyzed during the current study are/will be available upon request from Dr Severin Haug (severin.haug@isgf.uzh.ch). Individual participant data will be available (including data dictionaries). Individual participant data that underlie the results reported in our article, after deidentification (text, tables, figures, and appendices) will be shared. Data will be available beginning 9 months and ending 36 months following article publication. Researchers who provide a methodologically sound proposal will be able to get access to the data. Data will be provided for analyses to achieve aims in the approved proposal and for individual participant data meta-analysis. To gain access, data requestors will need to sign a data access agreement.

Intention to publish date

31/12/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes