Condition category
Mental and Behavioural Disorders
Date applied
07/03/2019
Date assigned
08/03/2019
Last edited
07/03/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Depression is a very common condition. It is one of the conditions causing the most sickness absence from work. Depression usually begins in early adulthood. It can be effectively treated with cognitive behavioral therapy (CBT). Unfortunately, such therapy is often difficult to access. This may be because it is difficult to find a therapist, or because of high costs. Some are afraid of stigma. Today, there is also CBT that is delivered over the internet (iCBT). iCBT is more easily available than conventional CBT. Young adults particularly may find iCBT an attractive alternative to conventional CBT. In many studies, iCBT has been shown to help with depressive symptoms. However, more research is needed. For example, it is not yet known whether iCBT can help reduce sickness absence among those employees who have depressive symptoms. This study investigates whether participation in an iCBT program “Mental Hub for Depression” helps reduce sickness absence among 18 to 34-year-old public sector employees. The study also aims to find out whether iCBT works as part of occupational health care. If iCBT shows to be an effective treatment, it can be used more widely. The findings of the study can help enhance the treatment of mental disorders, especially for young workers.

Who can participate?
18-34-year-old employees of the City of Helsinki (Finland), who have been continuously employed at least 4 month and who score more 9 or more points in the Beck Depression Inventory 21 completed at their visit with an occupational health nurse.

What does the study involve?
Participants are randomly allocated to one of two groups: control group or treatment group. Those in the control group receive care-as-usual (CAU), which is the care that occupational health care usually provides to employees with depressive symptoms. Those in the second group receive CAU as well, but in addition, they attend iCBT. iCBT involves one-hour therapy session once a week for 7 weeks. Sessions can be completed using a smartphone, tablet or computer. The purpose of the sessions is to provide the skills to manage depressive symptoms. Sickness absence of each participant is monitored for six months from the study entry. A longer follow-up of sickness absence is possible in future studies. All information is obtained from the employer’s and national administrative records. To find out whether participation in iCBT reduces sickness absence days, the numbers of sickness absence days in the two groups are compared.

What are the possible benefits and risks of participating?
Participation in the study is not considered harmful. All participants receive appropriate treatment for their depressive symptoms during the study. Participants have contact with health care professionals, who evaluate their health. Those in the iCBT group may benefit, but the benefits are individual and cannot be guaranteed in advance. All participants help increase the knowledge of the benefits of iCBT for the treatment of depressive symptoms, which is an important contribution.

Where is the study run from?
The University of Helsinki runs the study. Recruitment of participants takes place at the Occupational Health Helsinki, which provides primary care services for all of City of Helsinki employees. The use of services is free of charge for all the employees at the point of delivery.

When is the study starting and how long is it expected to run for?
January 2019 to August 2024

Who is funding the study?
Academy of Finland and the City of Helsinki

Who is the main contact?
Prof. Anne Kouvonen
anne.kouvonen@helsinki.fi

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anne Kouvonen

ORCID ID

http://orcid.org/0000-0001-6997-8312

Contact details

Faculty of Social Sciences
PO Box 54
Unioninkatu 37
Helsinki
00014
Finland
+358 (0)504487113
anne.kouvonen@helsinki.fi

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1

Study information

Scientific title

Depression and sickness Absence in young adults: a Quasi-experimental trial and web-based treatment Intervention (DAQI)

Acronym

DAQI

Study hypothesis

The Mental Hub for Depression iCBT plus CAU compared to CAU, will produce a decrease in depressive symptoms among young employees and, in turn, a decrease in sickness absence.

Ethics approval

Coordinating Ethics Committee of the Hospital District of Helsinki and Uusimaa, PO Box 705, 00029 HUS, Finland, Tel. +358 (0)504279345, Email: eettiset.toimikunnat@hus.fi - approval pending

Study design

Randomised controlled single-centre service-based trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Mild depressive symptoms (score ≥9 on the Beck Depression Inventory 21)

Intervention

This study is a randomised controlled single-centre service-based trial of an existing iCBT program (“Mental Hub iCBT for Depression”). The aim is to examine if this treatment can reduce the number of sickness absence days in 18–34-year-old public sector employees who are presenting at occupational health service with mild depressive symptoms (score ≥9 on the Beck Depression Inventory 21).

Participants will be randomly assigned to parallel groups in 1:1 ratio. Randomisation will be handled by a computerised random number generator administered by an independent person who is not involved in the study. The numbers corresponding to the treatment group (1=iCBT) and the control group (0=CAU), respectively, will be placed in sequentially numbered opaque sealed envelopes by a research assistant. The randomisation envelopes will be then manually assigned to all Occupational Health Helsinki OH nurses, who will in turn assign them to participants after the eligibility has been determined, trial discussed and written informed consent obtained. All researchers and nurses will be blind during the randomisation scheme; however, blinding for treatment allocation will not be possible as it will be clear to the referring OH nurse as well as the patient whether the patient has been allocated to iCBT treatment or the control arm. The allocation list will be stored in a password-protected file on the University of Helsinki server.

Control participants will be offered CAU, with no constraints on the range of treatments. The active condition will consist of seven weekly modules of iCBT, with support from a web therapist. iCBT involves a one-hour therapy session once a week for seven weeks. Sessions can be completed using a smartphone, tablet or computer. The purpose of the sessions is to provide the skills to manage depressive symptoms. Sickness absence of each participant is monitored for six months from the study entry. A longer follow-up of sickness absence is possible in future studies. All information is obtained from the employer’s and national administrative records. To find out whether participation in iCBT reduces sickness absence days, the numbers of sickness absence days in the two groups are compared.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Participants’ all-cause sickness absence (cumulative length of sickness absence in days) measured from the employer’s and national administrative records up to 6 months from study entry

Secondary outcome measures

Measured from the Finnish Social Insurance Institution’s administrative records and employer’s records up to 6 months from study entry:
1. Long-term sickness absence (over 11 calendar days) for mental disorders
2. Musculoskeletal disorders
3. Psychotropic medication use
4. Self-certified short sickness absence spells (up to 3 days)

Overall trial start date

01/01/2019

Overall trial end date

31/08/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Visiting an Occupational Health nurse
2. Being 18- to-34 years old at the time of recruitment
3. Continuously employed by the City of Helsinki for at least 4 months before recruitment
4. Score ≥ 9 on the Beck Depression Inventory 21

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

580

Participant exclusion criteria

1. Current high risk for suicide
2. Psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive-compulsive disorder
3. Not able to read Finnish, Swedish or English well (the intervention is only available in these languages)

Recruitment start date

01/10/2019

Recruitment end date

31/03/2021

Locations

Countries of recruitment

Finland

Trial participating centre

Occupational Health Helsinki
Helsinginkatu 24 PO Box 5600
Helsinki
00530
Finland

Sponsor information

Organisation

University of Helsinki

Sponsor details

PO Box 3
Fabianinkatu 33
Helsinki
00014
Finland
+358 (0)2941 911
firstname.lastname@helsinki.fi

Sponsor type

University/education

Website

https://www.helsinki.fi/en

Funders

Funder type

University/education

Funder name

Academy of Finland

Alternative name(s)

Suomen Akatemia, Finlands Akademi

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Finland

Funder name

City of Helsinki

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Protocol will be shortly (after ethics approval) submitted to a peer-review journal. The results will be published in peer-reviewed journals, lay publications and in conference and seminar presentations. The researchers aim to publish peer-reviewed papers in open access journals.

IPD sharing statement
The datasets generated and analysed during the current study will be available upon request from Prof Anne Kouvonen (anne.kouvonen@helsinki.fi) from 01/01/2023 to 31/12/2030. Non-identifiable data can be shared within the EEA/EU but can be analysed and published only in collaboration with the Helsinki Health Study research group. Consent will be obtained from participants.

Intention to publish date

01/05/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/03/2019: Trial's existence confirmed by Academy of Finland.