Attitudes of Professionals and the General Public in Israel Regarding Therapist Guided Internet Cognitive Behavioral Therapies (ICBT) to Treat Anxiety and Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 主要终点
- Change in Hamilton Depression Scale- 17 item adjusted version
研究概览
简要总结
This study examines uptake and attrition for internet based treatments for panic disorder and depression in Israel The primary benefits of this work will be a) in providing better understanding of ICBT for panic disorder and depression outcomes. Both panic and depression are heavy public health burdens, associated with a significant market potential for both therapeutic and diagnostic uses. b) In providing compatible scale to measure the working alliance during internet-based treatment.
详细描述
The current study examines ICBT for panic and depression in Israel. Compelling evidence regarding the efficacy of ICBT has been reported for the treatment of depression and various anxiety disorders (Mayo-Wilson & Montgomery; 2013). This the first study to examine ICBT for panic and depression in Israel. The primary focus will be on treatment outcomes (symptom reduction and improved functioning), attrition, and acceptability and comparing outcomes to previous studies of face to face and internet treatments, including on the main proposed mechanism of change; interpretation of bodily sensations via the BBSIQ. The efficacy of ICBT has been established in many studies, but is insufficient for implementation without adaptation to local cultural needs and language. We will also examine changes in healthcare utilization and costs according to the results.
For the full programs of the current study see: https://www.iterapi.se/sites/icbt_israel and https://www.iterapi.se/sites/depression_israel/
The limited role of the therapist in ICBT is mainly to allow greater scaling. a second goal of the current study is to fill this gap by examining different aspects of the alliance with treatment outcomes and attrition using a newly developed self-report measure, the Internet Patient Experiences and Attunement Responsiveness (I-PEAR). We propose that the I-PEAR and its subscales (I-PEAR program; hereafter I-PEARp, I-PEAR therapist; hereafter I-PEARt; and Therapist-rated I-PEAR; hereafter thI-PEAR) will explain more variance of the outcome and dropouts than traditional scales (i.e., WAI-6, WAI-T). In the current study we examined the relationship between the alliance measures to treatment outcomes and attrition. Alll secondary measures will be examined in terms of change and how their change is related to change in symptoms (PDSS, ASI, MI in panic, PHQ, HAM-D in depression). These analyses include changes in attachment, insight, and emotions. Research is limited about the role of insight in panic disorder, therefore another secondary aim of this study is to examine the role of clinical (i.e., SAIQ and SAI) and cognitive insight (i.e., BCIS and BABS) in panic disorder, if they change and their relationship to symptom severity (i.e., PDSS, ASI, MI), symptom change, and correlates (e.g., cognitive flexibility, metacognition, jumping to conclusions, and implicit theories). Secondary studies will examine changes in self-criticism, emotion preferences and goals, sexual functioning, and curiosity and their relationship to outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Principal DSM-5 diagnosis of panic disorder or depression
- •aged 18 years or older;
- •if on medications for panic or depression, the dosage has to remain constant for 2 months prior to the start of treatment and cannot be increased during treatment;
- •the participant must have access to the internet and be willing to use it -
排除标准
- •substance abuse or dependence within the last 6 months;
- •active suicide potential within the last 6 months;
- •any current or history of psychosis or bipolar I disorder
- •currently in weekly or biweekly psychotherapy
- •history of a complete course of panic or depression focused CBT
研究组 & 干预措施
internet based CBT
all patients will be offered active treatment via internet based CBT
干预措施: ICBT for panic and depression (Behavioral)
结局指标
主要结局
Change in Hamilton Depression Scale- 17 item adjusted version
时间窗: Baseline and 1 year follow-up
Independent evaluator measure of depression severity, higher score is more severe symptoms.total score is sum of the items, ranging from 0-52
Change in Panic Disorder Severity Scale: Independent Evaluator Version (for panic disorder)
时间窗: Baseline and 1 year follow-up
measure of a severity of panic disorder assessed by an independent evaluator. Only administered to panic patients. It is comprised of 7 items that are scored from 0-4, with a total scale score ranging from 0-28. Higher scores mean more severe panic disorder symptoms.
Change in Panic Disorder Severity Scale: Independent Evaluator Version (for panic disorder)
时间窗: Weekly during treatment from pre treatment to post treatment, up to 6 months apart
measure of a severity of panic disorder assessed by an independent evaluator. Only administered to panic patients. It is comprised of 7 items that are scored from 0-4, with a total scale score ranging from 0-28. Higher scores mean more severe panic disorder symptoms.
Change in Hamilton Depression Scale- 17 item adjusted version
时间窗: Baseline and post treatment, up to 6 months apart
Independent evaluator measure of depression severity, higher score is more severe symptoms. total score is sum of the items, ranging from 0-52
次要结局
- Change in Panic disorder severity scale - self report version(weekly during treatment from pre treatment to post treatment, up to 6 months apart)
- Change in Physicians Health Questionnaire (PHQ-9)(Baseline and 1 year followup)
- Change in Internet Patient's Experience of Attunement and Responsiveness scale (I-PEAR)(Baseline and after each module during treatment from pre treatment to post treatment)
- Change in Anxiety Sensitivity Index (ASI)(Weekly change during treatment from pre treatment to post treatment, up to 6 months apart)
- Change in Scale for the Assessment of Insight (SAI)(Baseline and 1 year follow-up)
- Change in The Pittsburgh Sleep Quality Index (PSQI)(Baseline and 1 year follow-up)
- Change in The Sheehan Disability Scale (SDS)(Baseline and 1 year follow-up)
- Change in Self-Appraisal of Illness Questionnaire (SAIQ)(Baseline and 1 year follow-up)
- Change in Mobility Inventory (MI)(Weekly change during treatment from pre treatment to post treatment, up to 6 months apart)
- Change in Depression Anxiety Stress Scales (DASS-21)(Baseline and 1 year follow-up)
- Change in Brown Assessment of Beliefs Scale (BABS)(Baseline and 1 year follow-up)
- Change in Beck Cognitive Insight Scale (BCIS)(After each module during treatment from pre treatment to post treatment, up to 6 months apart)
- Change in Cognitive Flexibility Inventory (CFI)(Baseline and 1 year follow-up)
- Change in Metacognition Questionnaire - 30 item version (MCQ-30)(Baseline and 1 year follow-up)
- Change in Beck Depression Inventory -21 (BDI-21)(Baseline and 1 year follow-up)
- Change in Implicit Theories of Emotion (TOE)(After each module during treatment from pre treatment to post treatment, up to 6 months apart)
- Change in Implicit Theories of Thoughts (TOT)(After each module during treatment from pre treatment to post treatment, up to 6 months apart)
- Change in Brief Body Sensations Interpretations Questionnaire (BBSIQ)(Baseline and 1 year follow-up)
- Change in Five-Dimensional Curiosity Scale (5DC)(Baseline and 1 year follow-up)
- Change in The five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)(Baseline and 1 year follow-up)
- Change in Work and Social Adjustment Scale (WSAS)(Baseline and 1 year follow-up)
- Change in Working Alliance Inventory (WAI-6)(Baseline and post treatment, up to 6 months apart)
- Change in The Experiences in Close Relationship Scale (ECR-S)(Baseline and 1 year follow-up)
- Change in The Agoraphobic Cognitions Questionnaire (ACQ)(Baseline and 1 year follow-up)
- Change in Social Support Questionnaire (SSQ6)(Baseline and post treatment, up to 6 months apart)
- Change in Acceptability Scale for internet Therapy (ASIT)(Baseline and 1 year follow-up)
- Change in Emotional Goals Questionnaire.(Baseline and post treatment, up to 6 months apart)
- Change in Panic disorder severity scale - self report version(Baseline and 1 year followup)
- Change in Physicians Health Questionnaire (PHQ-9)(Weekly during treatment from pre treatment to post treatment, up to 6 months apart)
- Change in Anxiety Sensitivity Index (ASI)(Baseline and 1 year follow-up)
- Change in Mobility Inventory (MI)(Baseline and 1 year follow-up)
- Change in Depression Anxiety Stress Scales (DASS-21)(After each module during treatment from pre treatment to post treatment, up to 6 months apart)
- Change in Brown Assessment of Beliefs Scale (BABS)(Baseline and post treatment, up to 6 months apart)
- Change in Scale for the Assessment of Insight (SAI)(Baseline and post treatment, up to 6 months apart)
- Change in The Pittsburgh Sleep Quality Index (PSQI)(Baseline and post treatment, up to 6 months apart)
- Change in The Sheehan Disability Scale (SDS)(Baseline and post treatment, up to 6 months apart)
- Change in Self-Appraisal of Illness Questionnaire (SAIQ)(Baseline and post treatment, up to 6 months apart)
- Change in Beck Cognitive Insight Scale (BCIS)(Baseline and 1 year follow-up)
- Change in Cognitive Flexibility Inventory (CFI)(Baseline and post treatment, up to 6 months apart)
- Change in Metacognition Questionnaire - 30 item version (MCQ-30)(Baseline and post treatment, up to 6 months apart)
- Change in Beck Depression Inventory -21 (BDI-21)(Baseline and post treatment, up to 6 months apart)
- Change in Implicit Theories of Emotion (TOE)(Baseline and 1 year follow-up)
- Change in Implicit Theories of Thoughts (TOT)(Baseline and 1 year follow-up)
- Change in Brief Body Sensations Interpretations Questionnaire (BBSIQ)(Baseline and post treatment, up to 6 months apart)
- Change in Five-Dimensional Curiosity Scale (5DC)(Baseline and post treatment, up to 6 months apart)
- Change in The five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)(Baseline and post treatment, up to 6 months apart)
- Change in Work and Social Adjustment Scale (WSAS)(Baseline and post treatment, up to 6 months apart)
- Change in The Experiences in Close Relationship Scale (ECR-S)(Baseline and post treatment, up to 6 months apart)
- Change in The Agoraphobic Cognitions Questionnaire (ACQ)(Baseline and post treatment, up to 6 months apart)
- Change in Acceptability Scale for internet Therapy (ASIT)(Baseline and post treatment, up to 6 months apart)
研究者
Jonathan D. Huppert
Professor
Hebrew University of Jerusalem