Evaluating the Effect of Different Clinical Routines and Supervision for ICBT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 401
- Locations
- 2
- Primary Endpoint
- Panic Disorder Severity Scale - Self Rated (PDSS-SR)
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
iCBT + Decision Support Tool
Internet-based Cognitive Behavioural Therapy where therapists have traditional clinical routines and supervision and also use a clinical decision support tool.
Intervention: Internet-based Cognitive Behavioural Therapy (iCBT) with Decision Support Tool (Behavioral)
Traditional iCBT
Internet-based Cognitive Behavioural Therapy with traditional clinical routines and supervision.
Intervention: Internet-based Cognitive Behavioural Therapy (iCBT) (Behavioral)
Outcomes
Primary Outcomes
Panic Disorder Severity Scale - Self Rated (PDSS-SR)
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.
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
Liebowitz Social Anxiety Scale, self-report (LSAS-SR)
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.
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
Montgomery-Åsberg Depression Rating Scale-Self report version (MADRS-S)
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.
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
Secondary Outcomes
- 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.)
- Adverse Events(At post-treatment (12 weeks after pre))
- 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))
- Patient experience(Post-treatment (12 weeks after pre))
- Treatment Credibility(Week 3 in treatment)
- Need for further treatment(At post-treatment (12 weeks after pre))
Investigators
Viktor Kaldo
Clinical Professor
Karolinska Institutet