Nationwide internet-delivered computer-assisted cognitive-behavioral therapy (iCBT) for psychiatric disorders
| ISRCTN | ISRCTN55123131 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55123131 |
| Secondary identifying numbers | TYH2019104 |
- Submission date
- 21/08/2019
- Registration date
- 26/08/2019
- Last edited
- 28/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Scientific
Hospital District of Helsinki and Uusimaa
Stenbäckinkatu 9
P.O. Box 100
Helsinki
FI-0029 HUS
Finland
 ORCID ID |
0000-0002-0782-6812 |
|---|---|
| Phone | +358 40 5136500 |
| grigori.joffe@hus.fi |
Study information
| Study design | Open-label prospective naturalistic effectiveness single-center trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Guided internet-delivered computer-assisted cognitive-behavioral therapy for psychiatric disorders - a nationwide naturalistic prospective effectiveness study. |
| 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(s) | 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 |
| 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 |
| 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 study start date | 15/02/2014 |
| Overall study end date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 5,000 |
| 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 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
Study participating centre
PO Box 100
Helsinki
FI-00029 HUS
Finland
Sponsor information
Government
Stenbäckinkatu 9
P.O. Box 100
Helsinki
FI-00029
Finland
| Phone | +358 40 6430511 |
|---|---|
| anne.pitkaranta@hus.fi | |
| Website | http://www.hus.fi |
"ROR" |
https://ror.org/020cpqb94 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Result for each HUS-iCBT program will be published in national and international scientific journals in 2019-2022. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | substudy results | 23/07/2020 | 28/07/2020 | Yes | No |
Editorial Notes
28/07/2020: Publication reference added.
23/08/2019: Trial’s existence confirmed by Helsinki University Hospital
