Attitudes of Professionals and the General Public in Israel Regarding ICBT

NCT ID: NCT04659577

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2022-01-31

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.

Conditions

Panic Disorder; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

internet based CBT

all patients will be offered active treatment via internet based CBT

Group Type: EXPERIMENTAL

ICBT for panic and depression

Intervention Type: BEHAVIORAL

The most known type of CBT for treating PD consists of two major strategies: cognitive restructuring, and interoceptive and structured exposure to bodily sensations that have become associated with panic attacks. As for depression, the most known type of CBT for treating depression consists of two major strategies: cognitive restructuring, the relationship between thoughts and feelings, behavioural activation, sleep hygiene and relaxation. Each ICBT program includes six modules, containing psychoeducation, cognitive restructuring exposures, acceptance, and consolidation of gains and relapse prevention. The online modules include reading passages, worksheets, videos, and homework assignments. After completing each module participants practice related skills and complete homework assignments. The treatment is up to 16 weeks long; participants are encouraged to complete the treatment within this time period, and reminders are sent to monitor their progress

Interventions

ICBT for panic and depression

The most known type of CBT for treating PD consists of two major strategies: cognitive restructuring, and interoceptive and structured exposure to bodily sensations that have become associated with panic attacks. As for depression, the most known type of CBT for treating depression consists of two major strategies: cognitive restructuring, the relationship between thoughts and feelings, behavioural activation, sleep hygiene and relaxation. Each ICBT program includes six modules, containing psychoeducation, cognitive restructuring exposures, acceptance, and consolidation of gains and relapse prevention. The online modules include reading passages, worksheets, videos, and homework assignments. After completing each module participants practice related skills and complete homework assignments. The treatment is up to 16 weeks long; participants are encouraged to complete the treatment within this time period, and reminders are sent to monitor their progress

Intervention Type: BEHAVIORAL

Other Intervention Names

Internet Cognitive behavioral therapy for panic and depressive disorder.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Israel National Institute for Health Policy and Health Services Research

OTHER_GOV

Sponsor Role: collaborator

Hebrew University of Jerusalem

OTHER

Sponsor Role: lead

Responsible Party

Jonathan D. Huppert

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

NIHRP 181-15

Identifier Type: -

Identifier Source: org_study_id