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Therapeutic Processes in iCBT for SAD

Primary Purpose

Social Anxiety Disorder, Social Phobia

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Internet delivered CBT for social anxiety disorder
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Social anxiety disorder, iCBT, Therapeutic processes

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Haifa

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Wait list

Intervention- active treatment

Arm Description

Wait list condition with no active treatment, length of 10 weeks, with weekly measurements.

Internet delivered CBT for social anxiety disorder

Outcomes

Primary Outcome Measures

Social anxiety severity
Post treatment Liebowitz Social Anxiety Scale (LSAS). Score ranges from 0 to 144 where higher score indicates more sever social anxiety
Diagnosis of SAD based on clinical interview
Diagnoses derived from the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS)
Social anxiety severity
Follow-up Liebowitz Social Anxiety Scale (LSAS). Score ranges from 0 to 144 where higher score indicates more sever social anxiety

Secondary Outcome Measures

Social anxiety severity - additional measure
Post treatment Social Phobia Inventory (SPIN). Score ranges from 0 to 68 where higher score indicates more sever social anxiety
Social anxiety severity - additional measure
Post treatment Social Phobia Inventory (SPIN). Score ranges from 0 to 68 where higher score indicates more sever social anxiety

Full Information

First Posted
December 11, 2017
Last Updated
May 9, 2021
Sponsor
University of Haifa
Collaborators
Hebrew University of Jerusalem, Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT03709615
Brief Title
Therapeutic Processes in iCBT for SAD
Official Title
Therapeutic Processes in Internet-Based CBT for Social Anxiety Disorder: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
June 20, 2020 (Actual)
Study Completion Date
June 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa
Collaborators
Hebrew University of Jerusalem, Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder, Social Phobia
Keywords
Social anxiety disorder, iCBT, Therapeutic processes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wait list
Arm Type
No Intervention
Arm Description
Wait list condition with no active treatment, length of 10 weeks, with weekly measurements.
Arm Title
Intervention- active treatment
Arm Type
Experimental
Arm Description
Internet delivered CBT for social anxiety disorder
Intervention Type
Behavioral
Intervention Name(s)
Internet delivered CBT for social anxiety disorder
Intervention Description
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."
Primary Outcome Measure Information:
Title
Social anxiety severity
Description
Post treatment Liebowitz Social Anxiety Scale (LSAS). Score ranges from 0 to 144 where higher score indicates more sever social anxiety
Time Frame
Change from Baseline LSAS at post treatment (12 weeks)
Title
Diagnosis of SAD based on clinical interview
Description
Diagnoses derived from the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS)
Time Frame
Change from Baseline ADIS diagnosis at post treatment (12 weeks)
Title
Social anxiety severity
Description
Follow-up Liebowitz Social Anxiety Scale (LSAS). Score ranges from 0 to 144 where higher score indicates more sever social anxiety
Time Frame
Change from Baseline LSAS at 6 months follow-up
Secondary Outcome Measure Information:
Title
Social anxiety severity - additional measure
Description
Post treatment Social Phobia Inventory (SPIN). Score ranges from 0 to 68 where higher score indicates more sever social anxiety
Time Frame
Change from Baseline SPIN at post treatment (12 weeks)
Title
Social anxiety severity - additional measure
Description
Post treatment Social Phobia Inventory (SPIN). Score ranges from 0 to 68 where higher score indicates more sever social anxiety
Time Frame
Change from Baseline SPIN at 6 months follow-up
Other Pre-specified Outcome Measures:
Title
Depressive symptoms severity
Description
Post treatment Beck Depression Inventory II, (BDI-II). Score ranges from 0 to 63 where higher score indicates more sever depression.
Time Frame
Change from Baseline BDI-II at post treatment (12 weeks)
Title
Depressive symptoms severity
Description
Post treatment Beck Depression Inventory II, (BDI-II). Score ranges from 0 to 63 where higher score indicates more sever depression.
Time Frame
Change from Baseline BDI-II at 6 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Idan M Aderka, PhD
Organizational Affiliation
University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Haifa
City
Haifa
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32584117
Citation
Shalom JG, Strauss AY, Huppert JD, Andersson G, Agassi OD, Aderka IM. Predicting sudden gains before treatment begins: An examination of pretreatment intraindividual variability in symptoms. J Consult Clin Psychol. 2020 Sep;88(9):809-817. doi: 10.1037/ccp0000587. Epub 2020 Jun 25.
Results Reference
derived

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Therapeutic Processes in iCBT for SAD

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