CompletedNot Applicable

Evaluating Clinical Routines for ICBT

Sweden401 participantsStarted 2021-12-03

Plain-language summary

The overall aim of this study is to test the clinical benefits of an AI-based decision support tool (DST) and to evaluate how the DST affects therapists and their patients with depression, social anxiety, or panic disorder during 12 weeks of ICBT.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years or older. * Social anxiety, panic disorder or depression diagnosis. * Stable or no antidepressant medication for at least 2 months. * No diseases, disorders, or substance abuse that required other, immediate attention (e.g., severe depression or suicidality). * Available time for treatment and acceptance of its format. * Proficient in Swedish. * No ongoing CBT. Exclusion Criteria: * Not available for assessment and diagnostic telephone interview. * Will not be in Sweden during the treatment period. * Not able to receive text messages on a Swedish mobile phone. * Not proficient in Swedish. * No access to computer and internet. * Not able to set aside about one hour a day to work on treatment. * Bipolar disorder, if seeking depression treatment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial looked at internet-based cognitive behavioral therapy (ICBT) for depression, panic disorder, and social anxiety — could ICBT be a realistic option for me, and how does it compare to the in-person therapy or medication you might otherwise recommend?
2The trial used self-report rating scales like the MADRS-S and LSAS-SR to track symptoms — does that mean the improvements measured were based on patients' own assessments, and how should I think about what that tells us about real-world effectiveness?
3Since this trial is listed as phase 'NA' and has already completed, does that mean ICBT delivered this way is already available outside a research setting, or would I still be accessing it through a study or specialist program?
4This study covered three different conditions — depression, panic disorder, and social anxiety — and I have one of these; is there enough evidence from trials like this one that ICBT works specifically for my diagnosis, or is the evidence stronger for some conditions than others?
5Because this trial has already finished, would my doctor be able to access any published results to help us decide whether ICBT through a clinical routine — rather than intensive specialist care — might be a good fit for my situation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Montgomery-Åsberg Depression Rating Scale-Self report version (MADRS-S)

Timeframe: Measured at pre-treatment, each week in treatment, post (12 weeks after pre), and follow-up after 1 year. Primary endpoint is difference in change/slope during treatment, based on available data from pre-treatment, weekly measures and post-treatment.

Panic Disorder Severity Scale - Self Rated (PDSS-SR)

Liebowitz Social Anxiety Scale, self-report (LSAS-SR)

Trial details

NCT IDNCT05321628

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-03

View on ClinicalTrials.gov More Depression trials