Attitudes of Professionals and the General Public in Israel Regarding ICBT

NCT04659577 | Completed

• 1 other identifier: NIHRP 181-15
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Panic Disorder; Depression

Outcome Measures

Primary Outcomes (4)

• Change in Panic Disorder Severity Scale: Independent Evaluator Version (for panic disorder)

  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.

  Weekly during treatment from pre treatment to post treatment, up to 6 months apart

• Change in Panic Disorder Severity Scale: Independent Evaluator Version (for panic disorder)

  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.

  Baseline and 1 year follow-up

• Change in Hamilton Depression Scale- 17 item adjusted version

  Independent evaluator measure of depression severity, higher score is more severe symptoms. total score is sum of the items, ranging from 0-52

  Baseline and post treatment, up to 6 months apart

• Change in Hamilton Depression Scale- 17 item adjusted version

  Independent evaluator measure of depression severity, higher score is more severe symptoms.total score is sum of the items, ranging from 0-52

  Baseline and 1 year follow-up

Secondary Outcomes (50)

• Change in Panic disorder severity scale - self report version

  Baseline and 1 year followup

• 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)

  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

Other Outcomes (11)

• Change in questionnaire of Implicit Association Test (qIAT) for Experiences in Close Relationship Scale-Short

  Baseline and post treatment, up to 6 months apart

• Change in Depressive Experience Questionnaire (DEQ)

  After each module from pre treatment to post treatment, up to 6 months apart

• Change in Depressive Experience Questionnaire (DEQ)

  Baseline and 1 year follow-up

Study Arms (1)

internet based CBT

EXPERIMENTAL

all patients will be offered active treatment via internet based CBT

Behavioral: ICBT for panic and depression

Interventions

ICBT for panic and depression 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

Also known as: Internet Cognitive behavioral therapy for panic and depressive disorder.

internet based CBT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebrew University of Jerusalem: lead
• Israel National Institute for Health Policy and Health Services Research: collaborator

MeSH Terms

Conditions

Panic Disorder; Depression

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All eligible people are enrolled to internet-based CBT for panic disorder or depression

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: December 9, 2020
• Study Start: November 1, 2016
• Primary Completion: August 31, 2021
• Study Completion: January 31, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07