NCT05321628

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2024

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

August 5, 2026

Status Verified

August 1, 2026

Enrollment Period

2.8 years

First QC Date

March 18, 2022

Last Update Submit

August 3, 2026

Conditions

DepressionPanic DisorderSocial Anxiety Disorder

Keywords

Internet treatmentcognitive behavioral therapyclinical decision support tool

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    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.

Secondary Outcomes (9)

  • Failed/Successful Treatment

    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)

    Screening, post-treatment (12 weeks after pre) and follow-up after 1 year.

  • WHO Disability Assessment Schedule (WHODAS)

    Screening, post-treatment (12 weeks after pre) and follow-up after 1 year.

  • Treatment adherence questionnaire

    Tri-weekly during treatment and at post-treatment (12 weeks after pre).

  • Internet Psychiatry Clinic evaluation questionnaire (version 3).

    Post-treatment (12 weeks after pre)

  • +4 more secondary outcomes

Other Outcomes (5)

  • Time spent by therapist on each patient.

    At each interaction with patient and post-treatment (12 weeks after pre).

  • Number of treatment modules each patient has completed.

    Throughout treatment from pre-treatment to post (12 weeks after pre)

  • Time efficiency

    Throughout treatment from pre-treatment to post (12 weeks after pre)

  • +2 more other outcomes

Study Arms (2)

iCBT + Decision Support Tool

EXPERIMENTAL

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

Traditional iCBT

ACTIVE COMPARATOR

Internet-based Cognitive Behavioural Therapy with traditional clinical routines and supervision.

Behavioral: Internet-based Cognitive Behavioural Therapy (iCBT)

Interventions

Internet-based Cognitive Behavioural Therapy (iCBT) with Decision Support ToolBEHAVIORAL

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 + Decision Support Tool
Internet-based Cognitive Behavioural Therapy (iCBT)BEHAVIORAL

iCBT, as described above, using only the traditional, detailed therapist manual.

Traditional iCBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internet Psychiatry Unit, Psykiatri Sydväst, SLSO

Stockholm, Huddinge, 141 86, Sweden

Location

MeSH Terms

Conditions

DepressionPanic DisorderPhobia, Social

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAnxiety DisordersMental DisordersPhobic Disorders

Study Officials

  • Viktor Kaldo

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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. Outcome assessors will not be informed that any randomization has occurred.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 18, 2022

First Posted

April 11, 2022

Study Start

December 3, 2021

Primary Completion

October 3, 2024

Study Completion

July 1, 2026

Last Updated

August 5, 2026

Record last verified: 2026-08

Locations

SE(1)