Therapeutic Processes in iCBT for SAD

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03709615
• Other study ID #: UHaifaCBT
• Status: Completed
• Phase: N/A
• Start date: December 20, 2017
• Est. completion date: June 20, 2020

Study information

• Verified date: May 2021
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 20, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder
• Social Phobia

Intervention

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."

Locations

Country	Name	City	State
Israel	University of Haifa	Haifa

Sponsors (3)

Lead Sponsor	Collaborator
University of Haifa	Hebrew University of Jerusalem, Linkoeping University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depressive symptoms severity	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)
Other	Depressive symptoms severity	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
Primary	Social anxiety severity	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)
Primary	Diagnosis of SAD based on clinical interview	Diagnoses derived from the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS)	Change from Baseline ADIS diagnosis at post treatment (12 weeks)
Primary	Social anxiety severity	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	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	Change from Baseline SPIN at post treatment (12 weeks)
Secondary	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	Change from Baseline SPIN at 6 months follow-up

External Links

•   Trial landing page (Hebrew)