NCT03709615

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

December 20, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

2.5 years

First QC Date

December 11, 2017

Last Update Submit

May 9, 2021

Conditions

Social Anxiety DisorderSocial Phobia

Keywords

Social anxiety disorderiCBTTherapeutic processes

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Social anxiety severity - additional measure

    Change from Baseline SPIN at post treatment (12 weeks)

  • Social anxiety severity - additional measure

    Change from Baseline SPIN at 6 months follow-up

Other Outcomes (2)

  • Depressive symptoms severity

    Change from Baseline BDI-II at post treatment (12 weeks)

  • Depressive symptoms severity

    Change from Baseline BDI-II at 6 months follow-up

Study Arms (2)

Wait list

NO INTERVENTION

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

Intervention- active treatment

EXPERIMENTAL

Internet delivered CBT for social anxiety disorder

Behavioral: Internet delivered CBT for social anxiety disorder

Interventions

Internet delivered CBT for social anxiety disorderBEHAVIORAL

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."

Intervention- active treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Haifa

Haifa, Israel

Location

Related Publications (2)

  • Shalom JG, Strauss AY, Huppert JD, Andersson G, Aderka IM. A theoretically based experimental manipulation of the processing of sudden gains: Considering reasons, meaning, and opportunities to leverage the gain. J Consult Clin Psychol. 2025 Feb;93(2):120-130. doi: 10.1037/ccp0000941. Epub 2024 Dec 30.

    PMID: 39913487DERIVED

  • 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.

    PMID: 32584117DERIVED

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Idan M Aderka, PhD

    University of Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 11, 2017

First Posted

October 17, 2018

Study Start

December 20, 2017

Primary Completion

June 20, 2020

Study Completion

June 20, 2020

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)