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Completed

NCT Number: NCT03709615

Therapeutic Processes in iCBT for SAD

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.

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders Social Phobia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Haifa

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet delivered CBT for social anxiety disorder

Behavioral

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."

Primary outcomes

  1. Social anxiety severity

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Social anxiety severity - additional measure

    Time frame: 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

    Time frame: 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 outcomes

  1. Depressive symptoms severity

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Hebrew University of Jerusalem
  • Linkoeping University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 17, 2018
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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