Condition category
Mental and Behavioural Disorders
Date applied
21/08/2019
Date assigned
26/08/2019
Last edited
28/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Depression and anxiety disorders are very common and cause serious sufferings and disability for patients, as well as substantial costs for society. Medications and psychotherapy are first-line treatments for most of these disorders, but psychotherapy is costly and its availability is poor in many countries and regions. Therefore, psychologists and psychiatrists have developed semi-automatic therapy programs. The majority of them uses methods of so-called cognitive-behavioral therapy (CBT). In these therapies, patients work with a smart computer program and a therapist follows the progress of treatment and guides and supports the patient. These therapies yield as good results as traditional face to face therapies and can be delivered through the internet (iCBT, where i stays for internet). The iCBTs are less costly, require less trained therapists and are place and time-independent. Typically, the communication between the patient and therapist happen in written in the beginning and end of therapy, as well as in between, as needed. Also, telephone calls can be added if needed. While the efficacy of iCBT in scientific studies is well established, little is known about there effectiveness in the “real world” of usual clinical practice.

The only available Finnish language iCBT for depression and anxiety disorders is developed and nationwide provided by the Department of Psychiatry of the Helsinki University Hospital (HUS). The aim of this study is to evaluate the effectiveness of this Finnish language iCBT (HUS-iCBT) in usual clinical practice.

Who can participate?
All physicians in Finland are authorized to refer their patients to HUS-iCBT if they suffer from ICD-10 defined depressive or anxiety disorder, have a reasonable command of Finnish language, have an access to internet, do not have a known diagnosis of a psychotic or serious neurological or substance abuse disorders that could hinder the therapy. All adult (≥18 y.o.) patients enrolled into HUS-iCBT programs are invited to participate in this study.

What does the study involve?
The participants receive HUS-iCBT as usual. Change in their symptom severity and Health-Related Quality of Life are measured prospectively from baseline to end-point (or to premature discontinuation).

What are the possible benefits and risks of participating?
All study patients will have the same usual HUS-iCBT as those who do not participate in the study. Since iCBT does not contain known risks, we therefore do not expect any risks from the study.

Where is the study run from?
Department of Psychiatry, Helsinki University Hospital, Finland

When is the study starting and how long is it expected to run for?
September 2015 to December 2019

Who is funding the study?
1. Government of Finland
2. Hospital Region of Helsinki and Uusimaa

Who is the main contact?
Prof. Grigori Joffe,
grigori.joffe@hus.fi

Trial website

Contact information

Type

Scientific

Primary contact

Prof Grigori Joffe

ORCID ID

http://orcid.org/0000-0002-0782-6812

Contact details

Hospital District of Helsinki and Uusimaa
Stenbäckinkatu 9
P.O. Box 100
Helsinki
FI-0029 HUS
Finland
+358 40 5136500
grigori.joffe@hus.fi

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

TYH2019104

Study information

Scientific title

Guided internet-delivered computer-assisted cognitive-behavioral therapy for psychiatric disorders - a nationwide naturalistic prospective effectiveness study.

Acronym

Study hypothesis

HUS-iCBT (a low resource-consuming, low-threshold iCBT program developed and nationwide provided by the Department of Psychiatry of Helsinki University Hospital, HUS) is as effective as earlier programs as assessed in regular clinical practice

Ethics approval

Approved 12/06/2014, Naisten, lasten ja psykiatrian eettinen toimikunta (Ethics Committee for Pediatrics, Gynecology/Obstetrics, and Psychiatry of the Hospital Region of Helsinki and Uusimaa (Keskuskirjaamo (Central Registry Office), P.O. Box 200, 00029 HUS, Finland; +358 9 4711; keskuskirjaamo@hus.fi.), ref: n\a

Study design

Open-label prospective naturalistic effectiveness single-center trial

Primary study design

Interventional

Secondary study design

Non randomised study

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

Depressive disorders, General Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Obsessive-Compulsive Disorder

Intervention

All physicians registered in Finland are authorized to refer their patients with a number of ICD-10 verified psychiatric disorders (mostly depressive and anxiety disorders) to municipality-purchased, internet-therapist supported HUS-iCBT. The time-schedule of the programs is flexible. Concomitant treatments are allowed.

All consented patients are enrolled in a pertinent diagnosis-specific iCBT program.

The treatment is Cognitive-Behavioral Therapy provided via the internet. A patient works with a highly structured, smart program. An internet-therapist supervises the progress and supports the patient. Therapy lasts from three to five (sometimes, six) months and consists of 7 to 12 steps (sessions). Homework is assigned between the sessions. The therapist and the patient interact in written (may be supplemented with telephone calls) in a safe, protected environment of the HUS-iCBT system. Therapist-patient contact happens in the beginning, in the middle and in the end of therapy or, if needed, more often. Currently available HUS-iCBT programs: Depressive Disorders, Panic disorder, Generalized Anxiety Disorder, Obsessive-Compulsive Disorder, Social Anxiety Disorder and Sleep Disorders; Bulimia Nervosa program is available soon.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Primary outcomes are a disorder-specific symptom measure scale.
For each specific disorder, we measure one or two pertinent symptom scales as primary measures: Beck’s Depression Inventory (BDI) for Depressive Disorders, Panic Disorder Severity Scale (PDSS-SR) for Panic disorder, Generalized Anxiety Disorder 7-item Scale (GAD-7) and Penn State Worry Questionnaire (PSWQ) for Generalized Anxiety Disorder, Obsessive-Compulsive Inventory, short version (OCI-R) for Obsessive-Compulsive Disorder, Social Phobia Inventory, Finnish version (SPIN-FIN) for Social Anxiety Disorder and Sleep Disorders, and Eating Disorder Examination Questionnaire (EDE-Q), the Eating Disorder Examination-Self-Report Questionnaire Version (EDE-Q) for Bulimia Nervosa. The scales are applied at baseline, mid-treatment and endpoint with the exception of GAD-7 which is applied as each session. All measures are filled in by patients online.

Secondary outcome measures

1. Overall Anxiety Severity and Impairment Scale (OASIS) assessed at baseline and mid-treatment
2. Health-Related Quality of Life scale 15D at baseline, end-point and three months follow-up

Overall trial start date

15/02/2014

Overall trial end date

31/12/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosis of a psychiatric disorder being explored
2. Aged 18 years or more
3. Reasonable command of Finnish language
4. Access to the internet
5. Provided informed consent
6. Referral to the HUS-iCBT by the patient’s treating physician

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

5,000

Participant exclusion criteria

1. Reported or observed suicidal intentions
2. Current alcohol misuse as judged by referring physician
3. Known diagnosis of schizophrenia or other psychotic disorder, bipolar disorder or serious personality disorder
4. Neurologic or neuropsychiatric disorder that adversely affects the patient’s cognitive performance

Recruitment start date

15/09/2015

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Finland

Trial participating centre

Department of Psychiatry, Helsinki University Hospital
Stenbäckinkatu 9 PO Box 100
Helsinki
FI-00029 HUS
Finland

Sponsor information

Organisation

Hospital District of Helsinki and Uusimaa

Sponsor details

Stenbäckinkatu 9
P.O. Box 100
Helsinki
FI-00029
Finland
+358 40 6430511
anne.pitkaranta@hus.fi

Sponsor type

Government

Website

http://www.hus.fi

Funders

Funder type

Government

Funder name

Government of Finland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Result for each HUS-iCBT program will be published in national and international scientific journals in 2019-2022.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

31/12/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2020 substudy results in https://pubmed.ncbi.nlm.nih.gov/32706658/ (added 28/07/2020)

Publication citations

Additional files

Editorial Notes

28/07/2020: Publication reference added. 23/08/2019: Trial’s existence confirmed by Helsinki University Hospital