Clinical trial NCT03709615: 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
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Social Phobia
Keywords: Social anxiety disorder
iCBT
Therapeutic processes
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Hebrew University of Jerusalem
name: Linkoeping University
First posted: 2018-10-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Social anxiety severity
timeFrame: Change from Baseline LSAS at post treatment (12 weeks)
measure: Diagnosis of SAD based on clinical interview
timeFrame: Change from Baseline ADIS diagnosis at post treatment (12 weeks)
measure: Social anxiety severity
timeFrame: Change from Baseline LSAS at 6 months follow-up
Secondary outcomes:
measure: Social anxiety severity - additional measure
timeFrame: Change from Baseline SPIN at post treatment (12 weeks)
measure: Social anxiety severity - additional measure
timeFrame: Change from Baseline SPIN at 6 months follow-up
Other outcomes:
measure: Depressive symptoms severity
timeFrame: Change from Baseline BDI-II at post treatment (12 weeks)
measure: Depressive symptoms severity
timeFrame: Change from Baseline BDI-II at 6 months follow-up
Locations:
city: Haifa
country: Israel
facility: University of Haifa
Study officials:
affiliation: University of Haifa
name: Idan M Aderka, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.