Therapeutic Processes in iCBT for SAD

May 9, 2021 updated by: Idan Moshe Aderka, University of Haifa

Therapeutic Processes in Internet-Based CBT for Social Anxiety Disorder: A Randomized Controlled Trial.

The current study examines therapeutic processes during internet-based cognitive-behavioral therapy for social anxiety disorder. Participants will be randomized to either treatment or wait-list conditions. Participants in the wait-list condition will receive active treatment following the wait-list period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Internet-based cognitive-behavioral therapy (iCBT) is an effective treatment for social anxiety disorder (SAD). However, little is known about the processes and mechanisms of change in this treatment. Compared to face to face (FTF) treatments, online interventions may operate through partially different mechanisms of change due to the text-based nature of the interaction and the reduced level of therapist involvement. The present randomized controlled trial will examine therapeutic processes during iCBT for SAD including the presence of sudden gains and their relationship to outcome, the relationship between anxiety and depressive symptoms along the course of treatment, changes in the therapeutic alliance and attrition from therapy. Moreover, we will compare iCBT for SAD with a wait-list control group and utilize weekly measurements of anxiety, depression, and SAD-related cognitions in both groups. This will facilitate comparison between temporal processes in both conditions and also shed light on processes occurring in wait-list conditions.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • University of Haifa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meeting DSM-5 criteria for social anxiety disorder.
  • Fluency in Hebrew
  • Access to internet

Exclusion Criteria:

  • Substance use disorders
  • Past or present psychosis
  • High levels of suicidality
  • Changes in pharmacological treatment 3 months or less prior to the start of the trial
  • Participation in other psychotherapeutic treatments during the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Wait list
Wait list condition with no active treatment, length of 10 weeks, with weekly measurements.
EXPERIMENTAL: Intervention- active treatment
Internet delivered CBT for social anxiety disorder
Behavioral: Internet delivered CBT for social anxiety disorder

An internet-based CBT for social anxiety based on a protocol from Andersson et al., 2006:

"Internet-based self-help with therapist feedback and in vivo group exposure for social phobia: a randomized controlled trial."

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social anxiety severity
Time Frame: Change from Baseline LSAS at post treatment (12 weeks)
Post treatment Liebowitz Social Anxiety Scale (LSAS). Score ranges from 0 to 144 where higher score indicates more sever social anxiety
Change from Baseline LSAS at post treatment (12 weeks)
Diagnosis of SAD based on clinical interview
Time Frame: Change from Baseline ADIS diagnosis at post treatment (12 weeks)
Diagnoses derived from the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS)
Change from Baseline ADIS diagnosis at post treatment (12 weeks)
Social anxiety severity
Time Frame: Change from Baseline LSAS at 6 months follow-up
Follow-up Liebowitz Social Anxiety Scale (LSAS). Score ranges from 0 to 144 where higher score indicates more sever social anxiety
Change from Baseline LSAS at 6 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social anxiety severity - additional measure
Time Frame: Change from Baseline SPIN at post treatment (12 weeks)
Post treatment Social Phobia Inventory (SPIN). Score ranges from 0 to 68 where higher score indicates more sever social anxiety
Change from Baseline SPIN at post treatment (12 weeks)
Social anxiety severity - additional measure
Time Frame: Change from Baseline SPIN at 6 months follow-up
Post treatment Social Phobia Inventory (SPIN). Score ranges from 0 to 68 where higher score indicates more sever social anxiety
Change from Baseline SPIN at 6 months follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms severity
Time Frame: Change from Baseline BDI-II at post treatment (12 weeks)
Post treatment Beck Depression Inventory II, (BDI-II). Score ranges from 0 to 63 where higher score indicates more sever depression.
Change from Baseline BDI-II at post treatment (12 weeks)
Depressive symptoms severity
Time Frame: Change from Baseline BDI-II at 6 months follow-up
Post treatment Beck Depression Inventory II, (BDI-II). Score ranges from 0 to 63 where higher score indicates more sever depression.
Change from Baseline BDI-II at 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Haifa

Collaborators

Linkoeping University
Hebrew University of Jerusalem

Investigators

  • Principal Investigator: Idan M Aderka, PhD, University of Haifa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 20, 2017

Primary Completion (ACTUAL)

June 20, 2020

Study Completion (ACTUAL)

June 20, 2020

Study Registration Dates

First Submitted

December 11, 2017

First Submitted That Met QC Criteria

October 14, 2018

First Posted (ACTUAL)

October 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 9, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHaifaCBT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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