Social Anxiety DisorderNCT03709615
Therapeutic Processes in iCBT for SAD
A study testing Internet delivered CBT for social anxiety disorder in people with Social Anxiety Disorder and Social Phobia, run by University of Haifa at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Social Anxiety Disorder, Social Phobia
- What is being tested?
- Internet delivered CBT for social anxiety disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Dec 2017to 20 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meeting DSM-5 criteria for social anxiety disorder.
- Fluency in Hebrew
- Access to internet
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Processes in Internet-Based CBT for Social Anxiety Disorder: A Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Social Anxiety Disorder, Social Phobia
- Being tested
- Internet delivered CBT for social anxiety disorder
- Keywords
- Social anxiety disorder, iCBT, Therapeutic processes
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet delivered CBT for social anxiety disorderBehavioural
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."
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Internet delivered CBT for social anxiety disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social anxiety severity
Post treatment Liebowitz Social Anxiety Scale (LSAS). Score ranges from 0 to 144 where higher score indicates more sever social anxiety
Measured: 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)
Measured: 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
Measured: Change from Baseline LSAS at 6 months follow-up
Secondary outcomes (2)
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
Measured: 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
Measured: Change from Baseline SPIN at 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start20 Dec 2017
- Primary completion20 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem, Linkoeping University
- Responsible party
- Principal investigator, Idan Moshe Aderka, University of Haifa
- Investigators
- Idan M Aderka, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709615
- Sponsor's protocol ID
- UHaifaCBT
- Status last verified
- May 2021
- First submitted
- 11 Dec 2017
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39913487Shalom 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.
PubMed 32584117
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Processes in Internet-Based CBT for Social Anxiety Disorder: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03709615
- Acronym / sponsor ID
- UHaifaCBT
- Conditions
- Social Anxiety Disorder, Social Phobia
- Keywords
- Social anxiety disorder, iCBT, Therapeutic processes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem, Linkoeping University
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait list | No intervention | –Wait list condition with no active treatment, length of 10 weeks, with weekly measurements. |
| Intervention- active treatment | Experimental | Behavioral: Internet delivered CBT for social anxiety disorderInternet delivered CBT for social anxiety disorder |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meeting DSM-5 criteria for social anxiety disorder.
- Fluency in Hebrew
- Access to internet
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet delivered CBT for social anxiety disorderAn 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." | Behavioural | Intervention- active treatment |
Primary outcome
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
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)
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
2 secondary outcomes
Social anxiety severity - additional measure
Time frame: Change from Baseline SPIN at post treatment (12 weeks)
Social anxiety severity - additional measure
Time frame: Change from Baseline SPIN at 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Derived from this study: PubMed 39913487Shalom 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.
- Derived from this study: PubMed 32584117Shalom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Idan M Aderka, PhD principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet delivered CBT for social anxiety disorder in people with Social Anxiety Disorder and Social Phobia, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social anxiety severity (time frame: Change from Baseline LSAS at post treatment (12 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709615, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.