Social PhobiaNCT01909193
CBT vs. ABM vs. for Social Anxiety
A study testing Attention Bias Modification (ABM) and Cognitive Behavior Therapy in people with Social Phobia, run by Hebrew University of Jerusalem at 1 site in Israel.
Trial summary
Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an individual cognitive behavior therapy, attention bias modification treatment (allocation ratio - 1.5:1). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Social Phobia
- What is being tested?
- Attention Bias Modification (ABM) and Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Nov 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Generalized Social Anxiety Disorder, LSAS>50
- If on medication, patients must be on a stable dose
- Hebrew language fluency
Who cannot join
- Primary Axis I or Axis II disorder other than SAD
- suicidal ideation
- Substance dependence within the past three months or current substance abuse
- Mental retardation or another pervasive developmental disability
- Current or past schizophrenia or psychosis, current bipolar disorder, or organic brain syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Behavior Therapy vs. Attention Bias Modification Treatment for Social Anxiety
Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an individual cognitive behavior therapy, attention bias modification treatment (allocation ratio - 1.5:1).
Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social anxiety disorder derived from structured clinical interviews based on Diagnostic and Statistical Manual (DSM) IV criteria.
The investigators expect to find significant reduction in social anxiety symptoms in all of the groups, with the cognitive behavior therapy group showing greater reduction in symptoms than the other groups. Mechanisms of change in all of the groups will be examined via measures of cognitive biases, affect, and other common and specific factors.
Read the detailed description
120 Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an individual cognitive behavior therapy (CBT), attention bias modification treatment (ABM)).
Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social anxiety disorder derived from structured clinical interviews based on DSM-IV criteria.
The investigators expect to find significant reduction in social anxiety symptoms in all of the groups, with the cognitive behavior therapy group showing greater reduction in symptoms than the other groups. Mechanisms of change in all of the groups will be examined via measures of cognitive biases, affect, and other common and specific factors.
- Conditions
- Social Phobia
- Being tested
- Attention Bias Modification (ABM), Cognitive Behavior Therapy
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Bias Modification (ABM)Behavioural
Attention training via 8 weekly repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
Cognitive Behavior TherapyBehavioural
CBT will consist of 16-20 weekly individual treatment sessions aimed to reduce symptoms via cognitive and behavioral interventions
| Study group | Role | What they receive |
|---|---|---|
| Attention Bias Modification (ABM) | Experimental | Attention training via 8 weekly repeated trials of a dot-probe task intended to direct attention away from threat stimuli. Receives: Behavioral: Attention Bias Modification (ABM) |
| Cognitive Behavior Therapy | Experimental | CBT will consist of 16-20 weekly individual treatment sessions aimed to reduce symptoms via cognitive and behavioral interventions Receives: Behavioral: Cognitive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liebovitz Social Anxiety Scale (LSAS) - diagnostic interview
LSAS is a 24-items clinician-administered scale developed for the assessment of fear and avoidance associated with social situations. The LSAS assesses a wide range of both social interaction and performance/observation situations, which are rated for degree of fear/anxiety and frequency of avoidance.
Measured: Expected time frame of up to 32 weeks per participant. Participants will be assessed before and after the administration of the treatment, every 4 weeks during treatment and at 3 months follow-up
Secondary outcomes (1)
Social Phobia Inventory (SPIN) - self-report questionnaire
The SPIN is a widely used 17-item self-report questionnaire that assesses fear, avoidance and physiological symptoms of social anxiety.
Measured: Up to 32 weeks per participant. The SPIN will be administered before and after each treatment session and at 3 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 posted26 Jul 2013 (estimated)
- Study startJan 2011
- Primary completionJul 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social PhobiaStudies 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Collaborators
- Israel Science Foundation
- Responsible party
- Principal investigator, Jonathan D. Huppert, Hebrew University of Jerusalem
- Investigators
- Jonathan D Huppert, PhD, Principal investigator, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909193
- Sponsor's protocol ID
- 1624
- Status last verified
- Feb 2016
- First submitted
- 24 Jul 2013
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavior Therapy vs. Attention Bias Modification Treatment for Social Anxiety
- ClinicalTrials.gov ID
- NCT01909193
- Acronym / sponsor ID
- 1624
- Conditions
- Social Phobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Collaborators
- Israel Science Foundation
- Study start
- Jan 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 26 Jul 2013 (estimated)
- 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.
Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an individual cognitive behavior therapy, attention bias modification treatment (allocation ratio - 1.5:1).
Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social anxiety disorder derived from structured clinical interviews based on Diagnostic and Statistical Manual (DSM) IV criteria.
The investigators expect to find significant reduction in social anxiety symptoms in all of the groups, with the cognitive behavior therapy group showing greater reduction in symptoms than the other groups. Mechanisms of change in all of the groups will be examined via measures of cognitive biases, affect, and other common and specific factors.
Detailed description
120 Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an individual cognitive behavior therapy (CBT), attention bias modification treatment (ABM)).
Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social anxiety disorder derived from structured clinical interviews based on DSM-IV criteria.
The investigators expect to find significant reduction in social anxiety symptoms in all of the groups, with the cognitive behavior therapy group showing greater reduction in symptoms than the other groups. Mechanisms of change in all of the groups will be examined via measures of cognitive biases, affect, and other common and specific factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Bias Modification (ABM) | Experimental | Behavioral: Attention Bias Modification (ABM)Attention training via 8 weekly repeated trials of a dot-probe task intended to direct attention away from threat stimuli. |
| Cognitive Behavior Therapy | Experimental | Behavioral: Cognitive Behavior TherapyCBT will consist of 16-20 weekly individual treatment sessions aimed to reduce symptoms via cognitive and behavioral interventions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Generalized Social Anxiety Disorder, LSAS>50
- If on medication, patients must be on a stable dose
- Hebrew language fluency
Key exclusion criteria (5 listed)
- Primary Axis I or Axis II disorder other than SAD
- suicidal ideation
- Substance dependence within the past three months or current substance abuse
- Mental retardation or another pervasive developmental disability
- Current or past schizophrenia or psychosis, current bipolar disorder, or organic brain syndrome
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 |
|---|---|---|
| Attention Bias Modification (ABM)Attention training via 8 weekly repeated trials of a dot-probe task intended to direct attention away from threat stimuli. | Behavioural | Attention Bias Modification (ABM) |
| Cognitive Behavior TherapyCBT will consist of 16-20 weekly individual treatment sessions aimed to reduce symptoms via cognitive and behavioral interventions | Behavioural | Cognitive Behavior Therapy |
Primary outcome
Liebovitz Social Anxiety Scale (LSAS) - diagnostic interview
Time frame: Expected time frame of up to 32 weeks per participant. Participants will be assessed before and after the administration of the treatment, every 4 weeks during treatment and at 3 months follow-up
LSAS is a 24-items clinician-administered scale developed for the assessment of fear and avoidance associated with social situations. The LSAS assesses a wide range of both social interaction and performance/observation situations, which are rated for degree of fear/anxiety and frequency of avoidance.
1 secondary outcome
Social Phobia Inventory (SPIN) - self-report questionnaire
Time frame: Up to 32 weeks per participant. The SPIN will be administered before and after each treatment session and at 3 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 23 Feb 2016.
Related trials for Social Phobia
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Therapy for Social Anxiety Disorder
Social Anxiety Disorder, Social Fear
Active, not recruiting
Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety
Autism Spectrum Disorder, Autism
Active, not recruiting
Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns
Body Dysmorphic Disorder, Eating Disorders
RecruitingPhase 4
Caplyta Versus Placebo for Adults With Social Anxiety Disorder
Social Anxiety Disorder (SAD)
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.
Jonathan D Huppert, PhD principal investigator
Hebrew University of Jerusalem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Bias Modification (ABM) and Cognitive Behavior Therapy in people with Social Phobia, run by Hebrew University of Jerusalem 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 23 Feb 2016. 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?
Liebovitz Social Anxiety Scale (LSAS) - diagnostic interview (time frame: Expected time frame of up to 32 weeks per participant. Participants will be assessed before and after the administration of the treatment, every 4 weeks during treatment and at 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2016.