Therapeutic Processes in iCBT for SAD

Sponsor
University of Haifa (Other)
Overall Status
Completed
CT.gov ID
NCT03709615
Collaborator
Hebrew University of Jerusalem (Other), Linkoeping University (Other)
120
1
2
30
4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Internet delivered CBT for social anxiety disorder
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Therapeutic Processes in Internet-Based CBT for Social Anxiety Disorder: A Randomized Controlled Trial.
Actual Study Start Date :
Dec 20, 2017
Actual Primary Completion Date :
Jun 20, 2020
Actual Study Completion Date :
Jun 20, 2020

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Wait list

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

Experimental: Intervention- active treatment

Internet delivered CBT for social anxiety disorder

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."

Outcome Measures

Primary Outcome Measures

  1. Social anxiety severity [Change from Baseline LSAS at post treatment (12 weeks)]

    Post treatment Liebowitz Social Anxiety Scale (LSAS). Score ranges from 0 to 144 where higher score indicates more sever social anxiety

  2. Diagnosis of SAD based on clinical interview [Change from Baseline ADIS diagnosis at post treatment (12 weeks)]

    Diagnoses derived from the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS)

  3. Social anxiety severity [Change from Baseline LSAS at 6 months follow-up]

    Follow-up Liebowitz Social Anxiety Scale (LSAS). Score ranges from 0 to 144 where higher score indicates more sever social anxiety

Secondary Outcome Measures

  1. Social anxiety severity - additional measure [Change from Baseline SPIN at post treatment (12 weeks)]

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

  2. Social anxiety severity - additional measure [Change from Baseline SPIN at 6 months follow-up]

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

Other Outcome Measures

  1. Depressive symptoms severity [Change from Baseline BDI-II at post treatment (12 weeks)]

    Post treatment Beck Depression Inventory II, (BDI-II). Score ranges from 0 to 63 where higher score indicates more sever depression.

  2. Depressive symptoms severity [Change from Baseline BDI-II at 6 months follow-up]

    Post treatment Beck Depression Inventory II, (BDI-II). Score ranges from 0 to 63 where higher score indicates more sever depression.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Haifa Haifa Israel

Sponsors and Collaborators

  • University of Haifa
  • Hebrew University of Jerusalem
  • Linkoeping University

Investigators

  • Principal Investigator: Idan M Aderka, PhD, University of Haifa

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Idan Moshe Aderka, Principal Investigator, University of Haifa
ClinicalTrials.gov Identifier:
NCT03709615
Other Study ID Numbers:
  • UHaifaCBT
First Posted:
Oct 17, 2018
Last Update Posted:
May 11, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Idan Moshe Aderka, Principal Investigator, University of Haifa
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2021