Ignite Creation Date:
2024-05-06 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05321628
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2022-03-18
Brief Title:
Evaluating Clinical Routines for ICBT
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Evaluating the Effect of Different Clinical Routines and Supervision for ICBT
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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
decrease the diagnose-specific symptoms during the treatment period among patients identified to be at risk of failure primary outcome
decrease the number of failed treatments among patients identified to be at risk
improve everyday functioning health related quality of life patient satisfaction number of Adverse Events experienced by the patient need for further treatment and sudden symptom changes among patients at risk
Increase the therapists amount of interaction and time spent on patients at risk
increase the adherence to treatment among patients at risk and
improve levels of symptoms functioning interaction and adherence when all patients also those not at risk are included
make therapists overall more time efficient defined as the ratio of decrease in symptoms therapist time spent on patient
increase therapist experience of using the DST the therapist manual including higher perceived helpfulness and credibility and the overall experience of supervision clinical routines and guidance of their clinical decisions
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
Green Patient likely to succeed consider spending less time on patient
Yellow Prediction too uncertain to give guidance
Light Red Patient likely to fail consider adjustments
Dark Red Patient very likely to fail adjustments must be implemented
A patient is considered to be at risk to fail if heshe 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 ie 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 Cohens d059 To be conservative it was estimated to be 050 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
The investigators hypothesize that DST in comparison to TRAD will
decrease the diagnose-specific symptoms during the treatment period among patients identified to be at risk of failure primary outcome
decrease the number of failed treatments among patients identified to be at risk
improve everyday functioning health related quality of life patient satisfaction number of Adverse Events experienced by the patient need for further treatment and sudden symptom changes among patients at risk
Increase the therapists amount of interaction and time spent on patients at risk
increase the adherence to treatment among patients at risk and
improve levels of symptoms functioning interaction and adherence when all patients also those not at risk are included
make therapists overall more time efficient defined as the ratio of decrease in symptoms therapist time spent on patient
increase therapist experience of using the DST the therapist manual including higher perceived helpfulness and credibility and the overall experience of supervision clinical routines and guidance of their clinical decisions
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
Green Patient likely to succeed consider spending less time on patient
Yellow Prediction too uncertain to give guidance
Light Red Patient likely to fail consider adjustments
Dark Red Patient very likely to fail adjustments must be implemented
A patient is considered to be at risk to fail if heshe 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 ie 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 Cohens d059 To be conservative it was estimated to be 050 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None