Evaluating the Effect of Different Clinical Routines and Supervision for ICBT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 2
- 主要终点
- Panic Disorder Severity Scale - Self Rated (PDSS-SR)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Internet-based Cognitive Behavioural Therapy (iCBT) with Decision Support Tool (Behavioral)
Traditional iCBT
Internet-based Cognitive Behavioural Therapy with traditional clinical routines and supervision.
干预措施: Internet-based Cognitive Behavioural Therapy (iCBT) (Behavioral)
结局指标
主要结局
Panic Disorder Severity Scale - Self Rated (PDSS-SR)
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
- 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))
研究者
Viktor Kaldo
Clinical Professor
Karolinska Institutet