Therapeutic Processes in iCBT for SAD

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Social Anxiety Disorder, Social Phobia

Intervention / Treatment
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* Behavioral: Internet delivered CBT for social anxiety disorder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Wait list<br>Wait list condition with no active treatment, length of 10 weeks, with weekly measurements. | |
| Experimental: Intervention- active treatment<br>Internet delivered CBT for social anxiety disorder | Behavioral: Internet delivered CBT for social anxiety disorder<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social anxiety disorder, iCBT, Therapeutic processes