Clinical trial NCT04659577: Attitudes of Professionals and the General Public in Israel Regarding ICBT
Official title: Attitudes of Professionals and the General Public in Israel Regarding Therapist Guided Internet Cognitive Behavioral Therapies (ICBT) to Treat Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder
Depression
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
Collaborators: name: Israel National Institute for Health Policy and Health Services Research
First posted: 2020-12-09
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All eligible people are enrolled to internet-based CBT for panic disorder or depression
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 -

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Panic Disorder Severity Scale: Independent Evaluator Version (for panic disorder)
timeFrame: Weekly during treatment from pre treatment to post treatment, up to 6 months apart
measure: Change in Panic Disorder Severity Scale: Independent Evaluator Version (for panic disorder)
timeFrame: Baseline and 1 year follow-up
measure: Change in Hamilton Depression Scale- 17 item adjusted version
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Hamilton Depression Scale- 17 item adjusted version
timeFrame: Baseline and 1 year follow-up
Secondary outcomes:
measure: Change in Panic disorder severity scale - self report version
timeFrame: Baseline and 1 year followup
measure: Change in Panic disorder severity scale - self report version
timeFrame: weekly during treatment from pre treatment to post treatment, up to 6 months apart
measure: Change in Physicians Health Questionnaire (PHQ-9)
timeFrame: Weekly during treatment from pre treatment to post treatment, up to 6 months apart
measure: Change in Physicians Health Questionnaire (PHQ-9)
timeFrame: Baseline and 1 year followup
measure: Change in Internet Patient's Experience of Attunement and Responsiveness scale (I-PEAR)
timeFrame: Baseline and after each module during treatment from pre treatment to post treatment
measure: Change in Anxiety Sensitivity Index (ASI)
timeFrame: Baseline and 1 year follow-up
measure: Change in Anxiety Sensitivity Index (ASI)
timeFrame: Weekly change during treatment from pre treatment to post treatment, up to 6 months apart
measure: Change in Mobility Inventory (MI)
timeFrame: Baseline and 1 year follow-up
measure: Change in Mobility Inventory (MI)
timeFrame: Weekly change during treatment from pre treatment to post treatment, up to 6 months apart
measure: Change in Depression Anxiety Stress Scales (DASS-21)
timeFrame: After each module during treatment from pre treatment to post treatment, up to 6 months apart
measure: Change in Depression Anxiety Stress Scales (DASS-21)
timeFrame: Baseline and 1 year follow-up
measure: Change in Brown Assessment of Beliefs Scale (BABS)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Brown Assessment of Beliefs Scale (BABS)
timeFrame: Baseline and 1 year follow-up
measure: Change in Scale for the Assessment of Insight (SAI)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Scale for the Assessment of Insight (SAI)
timeFrame: Baseline and 1 year follow-up
measure: Change in The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and 1 year follow-up
measure: Change in The Sheehan Disability Scale (SDS)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in The Sheehan Disability Scale (SDS)
timeFrame: Baseline and 1 year follow-up
measure: Change in Self-Appraisal of Illness Questionnaire (SAIQ)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Self-Appraisal of Illness Questionnaire (SAIQ)
timeFrame: Baseline and 1 year follow-up
measure: Change in Beck Cognitive Insight Scale (BCIS)
timeFrame: Baseline and 1 year follow-up
measure: Change in Beck Cognitive Insight Scale (BCIS)
timeFrame: After each module during treatment from pre treatment to post treatment, up to 6 months apart
measure: Change in Cognitive Flexibility Inventory (CFI)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Cognitive Flexibility Inventory (CFI)
timeFrame: Baseline and 1 year follow-up
measure: Change in Metacognition Questionnaire - 30 item version (MCQ-30)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Metacognition Questionnaire - 30 item version (MCQ-30)
timeFrame: Baseline and 1 year follow-up
measure: Change in Beck Depression Inventory -21 (BDI-21)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Beck Depression Inventory -21 (BDI-21)
timeFrame: Baseline and 1 year follow-up
measure: Change in Implicit Theories of Emotion (TOE)
timeFrame: Baseline and 1 year follow-up
measure: Change in Implicit Theories of Emotion (TOE)
timeFrame: After each module during treatment from pre treatment to post treatment, up to 6 months apart
measure: Change in Implicit Theories of Thoughts (TOT)
timeFrame: Baseline and 1 year follow-up
measure: Change in Implicit Theories of Thoughts (TOT)
timeFrame: After each module during treatment from pre treatment to post treatment, up to 6 months apart
measure: Change in Brief Body Sensations Interpretations Questionnaire (BBSIQ)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Brief Body Sensations Interpretations Questionnaire (BBSIQ)
timeFrame: Baseline and 1 year follow-up
measure: Change in Five-Dimensional Curiosity Scale (5DC)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Five-Dimensional Curiosity Scale (5DC)
timeFrame: Baseline and 1 year follow-up
measure: Change in The five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in The five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)
timeFrame: Baseline and 1 year follow-up
measure: Change in Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline and 1 year follow-up
measure: Change in Working Alliance Inventory (WAI-6)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in The Experiences in Close Relationship Scale (ECR-S)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in The Experiences in Close Relationship Scale (ECR-S)
timeFrame: Baseline and 1 year follow-up
measure: Change in The Agoraphobic Cognitions Questionnaire (ACQ)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in The Agoraphobic Cognitions Questionnaire (ACQ)
timeFrame: Baseline and 1 year follow-up
measure: Change in Social Support Questionnaire (SSQ6)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Acceptability Scale for internet Therapy (ASIT)
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Acceptability Scale for internet Therapy (ASIT)
timeFrame: Baseline and 1 year follow-up
measure: Change in Emotional Goals Questionnaire.
timeFrame: Baseline and post treatment, up to 6 months apart
Other outcomes:
measure: Change in questionnaire of Implicit Association Test (qIAT) for Experiences in Close Relationship Scale-Short
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Depressive Experience Questionnaire (DEQ)
timeFrame: After each module from pre treatment to post treatment, up to 6 months apart
measure: Change in Depressive Experience Questionnaire (DEQ)
timeFrame: Baseline and 1 year follow-up
measure: Change in Distressing Thoughts
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Distressing Thoughts
timeFrame: Baseline and 1 year follow-up
measure: Change in Current Emotion
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Current Emotion
timeFrame: Baseline and 1 year follow-up
measure: Change in Emotional Preferences
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in Emotional Preferences
timeFrame: Baseline and 1 year follow-up
measure: Change in Emotional Preferences Task
timeFrame: Baseline and post treatment, up to 6 months apart
measure: Change in State-Reappraisal Inventory (SRI)
timeFrame: after each module during treatment from pre treatment to post treatment, up to 6 months apart
Locations:
Study officials:
References: