An interventional study of Internet-based Cognitive Behavioural Therapy (iCBT) with Decision Support Tool and Internet-based Cognitive Behavioural Therapy (iCBT) in Depression, Panic Disorder and Social Anxiety Disorder, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
The project aims to evaluate if therapist-supported ICBT with a DST that guides therapists in addition to a traditional therapist manual (the DST arm) are superior to ICBT using only the therapist manual (TRAD) arm.
The investigators hypothesize that DST, in comparison to TRAD, will:
The study is designed as a triple blind randomized controlled trial, where half of the therapists are allocated to DST and the other half to TRAD. Each patient is also randomized between those conditions. The therapists and patients will be blind to what group they are allocated to and the post-treatment assessors will also be blind to what group the patients belong to. The therapists and patients will know that they are randomized, but will be informed that the randomization concerns two different types of clinical routines and supervision, and will thus be blind to the true purpose of randomization. After randomization both groups will be informed that they are in the experimental group to lower the risk for nocebo effects.
The DST provides visual feedback about patient current adherence and symptoms levels, as well as predictions of final outcome and adherence, and also use four color indicators to guide the therapist:
A patient is considered to be at risk to fail if he/she gets a Light Red or Dark Red indication.
Primary outcome is the diagnose-specific symptom rating for each of the three ICBT-treatments that are used in the trial for Depression (MADRS-S), Panic Disorder (PDSS-SR), and Social Anxiety Disorder (LSAS-SR) respectively. Failed treatment are defined as being neither a responder (50% symptom reduction) nor a remitter (under a previously specified cut-off for each respective diagnose-specific symptom measure).
Primary analyses are performed according to intent-to-treat and, to handle missing data, with an HLM-model that test the interaction of Time x Arm and includes all available symptom data from pre to post, including weekly measures during treatment. It includes the estimated 50% of all patients that will be indicated as at risk (i.e. also control patients in TRAD, although their therapists never see the prediction because they do not use the DST). In a previous proof-of-concept trial the effect corresponding to our primary analysis was Cohen's d=0.59. To be conservative it was estimated to be 0.50. A power of 80% and an attrition of 20% would require 158 patients identified as at risk of failure, and thus 316 in total. To increase the less easily estimated power for secondary measures, the aim is to include 350 patients.
The trial will follow the guidelines of Good Clinical Practice adapted for psychological treatment.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 401 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Internet-based Cognitive Behavioural Therapy where therapists have traditional clinical routines and supervision and also use a clinical decision support tool.
Behavioral: Internet-based Cognitive Behavioural Therapy (iCBT) with Decision Support Tool
Internet-based Cognitive Behavioural Therapy with traditional clinical routines and supervision.
Behavioral: Internet-based Cognitive Behavioural Therapy (iCBT)
Cognitive Behavioural Therapy för depression, panic disorder and social anxiety delivered thru texts and home works assignments via an internet platform with therapist weekly support through text messages. Therapist use a traditional, detailed therapist manual with the additions of a Clinical Decision Support Tool (DST) that identifies patients at risk of treatment failure and give suggestions to the therapist on how to act in relation to the specific patient.
iCBT, as described above, using only the traditional, detailed therapist manual.
Montgomery-Åsberg Depression Rating Scale-Self report version (MADRS-S)
A self-rating scale for depression, specially developed to be sensitive to change. Is in this study the primary symptom measure for depression, where higher scores means more symptoms of depression. Min - Max score = 0 - 54
Time frame: 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)
A self-report scale for panic disorder that has been shown to be sensitive to change with treatment. Is in this study the primary symptom measure for panic disorder, where higher scores means more panic disorder symptoms. Min - Max score = 0 - 28
Time frame: 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.
Liebowitz Social Anxiety Scale, self-report (LSAS-SR)
A self-rated scale for assessment of social anxiety disorder and it has two subscales for fear and avoidance. Is in this study the primary symptom measure for social anxiety, where higher scores means more symptoms of social anxiety. Min - Max score = 0 - 144
Time frame: 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.
Failed/Successful Treatment
Failure are defined as being neither a responder (50% symptom reduction from pre-treatment) nor a remitter (\<11 on MADRS-S; \<8 on PDSS-SR; or \<36 on LSAS-SR)
Time frame: From pre-treatment to post-treatment (12 weeks after pre). Sensitivity analysis: to post (12 weeks after pre) or last available weekly symptom measure
Euroqol (EQ-5D)
A short questionnaire for measuring health related quality of life.
Time frame: Screening, post-treatment (12 weeks after pre) and follow-up after 1 year.
WHO Disability Assessment Schedule (WHODAS)
A self-rated measure of daily functioning and an assessment instrument for health and disability available in 36- and 12-item versions. We will use the 12-item version (WHODAS-12).
Time frame: Screening, post-treatment (12 weeks after pre) and follow-up after 1 year.
Treatment adherence questionnaire
Questions focusing on how they patients have worked with the treatment.
Time frame: Tri-weekly during treatment and at post-treatment (12 weeks after pre).
Internet Psychiatry Clinic evaluation questionnaire (version 3).
Client Satisfaction Questionnaire 8 items version (CSQ-8) + 18 items concerning patients experience of the treatment in general, the treatment program, and adverse events.
Time frame: Post-treatment (12 weeks after pre)
Patient experience
Specifically designed questions focusing on patients experience of the treatment adaptations, feelings of empowerment, and other aspects of treatment.
Time frame: Post-treatment (12 weeks after pre)
Treatment Credibility
Patient-rated Treatment Credibility Scale (min - max = 0 - 50, higher scores indicate higher perceived treatment credibility)
Time frame: Week 3 in treatment
Adverse Events
Number of Adverse Events and Serious Adverse Events reported by patient
Time frame: At post-treatment (12 weeks after pre)
Need for further treatment
Patient reported need for further treatment
Time frame: At post-treatment (12 weeks after pre)
Time spent by therapist on each patient.
Logged in the treatment plattform.
Time frame: At each interaction with patient and post-treatment (12 weeks after pre).
Number of treatment modules each patient has completed.
Coded from the treatment plattform.
Time frame: Throughout treatment from pre-treatment to post (12 weeks after pre)
Time efficiency
Degree of change on primary outcome divided by therapist time spent on the patient.
Time frame: Throughout treatment from pre-treatment to post (12 weeks after pre)
Therapist experience of using DST / manual (not related to a specific patient)
Therapists experience of using the DST / the therapist manual, including perceived helpfulness and credibility and the overall experience of supervision, clinical routines, and guidance of their clinical decisions.
Time frame: Time-point not possible to specify in weeks. Measured either when the therapist has fully treated 5 patients or when the therapist leave the study (if that happens before treating 5 patients and has treated at least 1 patient)
System Usability Scale (SUS)
Measuring usability of the DST from the therapist perspective (not related to a specific patient). Min - Max score = 10 - 50
Time frame: Time-point not possible to specify in weeks. Measured either when the therapist has fully treated 5 patients or when the therapist leave the study (if that happens before treating 5 patients and has treated at least 1 patient)
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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