Digitala Vetenskapliga Arkivet

Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
Study protocol for a triple-blind randomised controlled trial evaluating a machine learning-based predictive clinical decision support tool for internet-delivered cognitive behaviour therapy (ICBT) for depression and anxiety
Karolinska Institutet, Sweden;Region Stockholm, Sweden.
Karolinska Institutet, Sweden;Region Stockholm, Sweden.
Karolinska Institutet, Sweden;Region Stockholm, Sweden;RISE, Sweden;UCL, UK.
UCL, UK;Karolinska Institutet, Sweden.
Show others and affiliations
2025 (English)In: Internet Interventions, ISSN 2214-7829, Vol. 40, article id 100816Article in journal (Refereed) Published
Abstract [en]

Introduction: Therapist-supported internet-based Cognitive Behavioural Therapy (ICBT) has strong scientific support, but all patients are not helped, and further improvements are needed. Personalized medicine could enhance ICBT. One promising approach uses a Machine learning (ML) based predictive decision support tool (DST) to help therapists identify patients at risk of treatment failure and adjust their treatments accordingly. ICBT is a suitable clinical context for developing and testing such predictive DST's, since its delivery is quite flexible and can quickly be adapted for probable non-responders, for example by increasing the level and nature of therapist support, to avoid treatment failures and improve overall outcomes. This type of strategy has never been tested in a triple-blind randomised controlled trial (RCT) and has rarely been studied in ICBT. The aim of this protocol is to expand on previous registered protocols with more detailed descriptions of methods and analyses before analyses is being conducted. Methods and analysis: A triple blind RCT comparing ICBT with a DST (DST condition), to ICBT as usual (TAU condition). The primary objective is to evaluate if the DST condition is superior to the TAU condition in decreasing diagnose-specific symptoms among patients identified to be at risk of failure. Secondary objectives are to evaluate if the DST improves functioning, interaction, adherence, patient satisfaction, and therapist time efficiency and decreases the number of failed treatments. Additionally, we will investigate the therapists' experience of using the DST. Patients and therapists have been recruited nationally. They were randomised and given a sham rationale for the trial to ensure allocation blindness. The total number of patients included was 401, and assessments were administered pre-treatment, weekly during treatment, at post-treatment and at 12-month follow-up. Primary outcome is one of the three diagnosis-specific symptom rating scales for respective treatment and primary analysis is difference in change from pre- to post-treatment for at-risk patients on these scales. Human ethics and consent to participate: Informed consent to participate in the study was obtained from all participants. Both therapists and patients are participants in this trial. For patients, informed consent to participate in the study was obtained when they registered interest for the study via the study's secure web platform and carried out initial screening before the diagnostic and fit for treatment assessment, they first received the research subject information and were asked for consent by digitally signing that they had read and understood the information. For therapists who were part of the study, consent was requested after they had registered their interest. Therapists then received an email with a link to the study's secure web platform with the research person's information and were asked for consent by digitally signing that they had read and understood the information. All documents are stored in secure, locked filing cabinets on the clinic's premises or on a secure digital consent database. Approval committee: Approved by the Swedish Ethical Review Authority (SERA), record number 2020-05772.

Place, publisher, year, edition, pages
Elsevier, 2025. Vol. 40, article id 100816
National Category
Applied Psychology
Research subject
Social Sciences, Psychology
Identifiers
URN: urn:nbn:se:lnu:diva-137296DOI: 10.1016/j.invent.2025.100816ISI: 001440385400001Scopus ID: 2-s2.0-85219026596OAI: oai:DiVA.org:lnu-137296DiVA, id: diva2:1946318
Available from: 2025-03-20 Created: 2025-03-20 Last updated: 2025-04-10Bibliographically approved

Open Access in DiVA

fulltext(2030 kB)11 downloads
File information
File name FULLTEXT01.pdfFile size 2030 kBChecksum SHA-512
3e4220c074a493db4bc6a8046bddc1eb4cbef7eec95da66d3234044e9f9d5a9c7f99993f243bb299628e499ebfdaa146cc0836d0b67f4b7d90f55552fb44a19c
Type fulltextMimetype application/pdf

Other links

Publisher's full textScopus

Search in DiVA

By author/editor
Kaldo, Viktor
By organisation
Department of Psychology
In the same journal
Internet Interventions
Applied Psychology

Search outside of DiVA

GoogleGoogle Scholar
Total: 11 downloads
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

doi
urn-nbn

Altmetric score

doi
urn-nbn
Total: 22 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf