Social PhobiaPhase 2CBMSPNCT01503151
Cognitive Biases Modification Treatment for Social Anxiety
A Phase 2 study testing Attention Bias Modification Treatment (ABMT), Interpretation Bias Modification (IBM) and Attention and Interpretive biases modification (CBM) in people with Social Phobia, run by Tel Aviv University at 1 site in Israel.
Trial summary
Adults with Social Phobia will be randomly assigned to either an attention bias modification treatment, interpretation bias modification treatment, both, or a placebo control condition not designed to change cognitive bias patterns. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Phobia
- What is being tested?
- Attention Bias Modification Treatment (ABMT), Interpretation Bias Modification (IBM) and Attention and Interpretive biases modification (CBM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Mar 2014
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People suffering from social anxiety
Who cannot join
- Pharmacological or Psychological treatment
Trial locations and contacts
1 site in 1 country.
About this study
Adults with Social Phobia will be randomly assigned to either an attention bias modification treatment, interpretation bias modification treatment, both, or a placebo control condition not designed to change cognitive bias patterns.
Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social phobia disorder and symptom counts derived from structured clinical interviews based on DSM-IV criteria.
The investigators expect to find significant reduction in social anxiety symptoms in the Treatment groups relative to the placebo control group. The investigators want to find out the relative efficacy of attention and interpretation oriented treatments and the combination of the two.
- Conditions
- Social Phobia
- Being tested
- Attention Bias Modification Treatment (ABMT), Interpretation Bias Modification (IBM), Control Condition, Attention and Interpretive biases modification (CBM)
- Keywords
- attention bias modification treatment, interpretive bias modification, cognitive bias modification, attention training, social anxiety
- 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 Treatment (ABMT)Behavioural
Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.
Interpretation Bias Modification (IBM)Behavioural
Interpretive Bias Modification Treatment (IBMT) using a computerized task modified to facilitate a more benign interpretation bias.
Control ConditionBehavioural
Attention and interpretation training using a computerized tasks not intended to alter threat-related biases patterns.
Attention and Interpretive biases modification (CBM)Behavioural
Attention and interpretation training via computerized tasks intended to direct attention away from threat stimuli and to facilitate a more benign interpretation bias.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | repeated trials of a dot-probe task and repeated trials of an interpretation task, both not intended to change threat-related biases patterns. Receives: Behavioral: Control Condition |
| Attention Bias Modification (ABM) | Experimental | Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli. Receives: Behavioral: Attention Bias Modification Treatment (ABMT) |
| Interpretation Bias Modification (IBM) | Experimental | Interpretation training intended to facilitating a more benign interpretation bias Receives: Behavioral: Interpretation Bias Modification (IBM) |
| Attention and interpretation biases modification | Experimental | Attention and interpretation training intended to direct cognitive biases away from threat stimulus. Receives: Behavioral: Attention and Interpretive biases modification (CBM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. 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 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols
Secondary outcomes (1)
The Mini International Neuropsychiatric Interview (MINI).
The Mini International Neuropsychiatric Interview (MINI) is a short diagnostic structured interview (DSI) developed to explore 17 disorders according to Diagnostic and Statistical Manual diagnostic criteria (DSM)
Measured: expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2014
- Study completionMar 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yair Bar-Haim, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503151
- Sponsor's protocol ID
- CBM_SP_2012
- Acronym
- CBMSP
- Status last verified
- Dec 2014
- First submitted
- 29 Dec 2011
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Biases Modification Treatment for Social Anxiety
- ClinicalTrials.gov ID
- NCT01503151
- Acronym / sponsor ID
- CBMSP / CBM_SP_2012
- Conditions
- Social Phobia
- Keywords
- attention bias modification treatment, interpretive bias modification, cognitive bias modification, attention training, social anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Jan 2012 (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 Phobia will be randomly assigned to either an attention bias modification treatment, interpretation bias modification treatment, both, or a placebo control condition not designed to change cognitive bias patterns.
Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social phobia disorder and symptom counts derived from structured clinical interviews based on DSM-IV criteria.
The investigators expect to find significant reduction in social anxiety symptoms in the Treatment groups relative to the placebo control group. The investigators want to find out the relative efficacy of attention and interpretation oriented treatments and the combination of the two.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Behavioral: Control Conditionrepeated trials of a dot-probe task and repeated trials of an interpretation task, both not intended to change threat-related biases patterns. |
| Attention Bias Modification (ABM) | Experimental | Behavioral: Attention Bias Modification Treatment (ABMT)Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli. |
| Interpretation Bias Modification (IBM) | Experimental | Behavioral: Interpretation Bias Modification (IBM)Interpretation training intended to facilitating a more benign interpretation bias |
| Attention and interpretation biases modification | Experimental | Behavioral: Attention and Interpretive biases modification (CBM)Attention and interpretation training intended to direct cognitive biases away from threat stimulus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People suffering from social anxiety
Key exclusion criteria (1 listed)
- Pharmacological or Psychological treatment
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 Treatment (ABMT)Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns. | Behavioural | Attention Bias Modification (ABM) |
| Interpretation Bias Modification (IBM)Interpretive Bias Modification Treatment (IBMT) using a computerized task modified to facilitate a more benign interpretation bias. | Behavioural | Interpretation Bias Modification (IBM) |
| Control ConditionAttention and interpretation training using a computerized tasks not intended to alter threat-related biases patterns. | Behavioural | Placebo |
| Attention and Interpretive biases modification (CBM)Attention and interpretation training via computerized tasks intended to direct attention away from threat stimuli and to facilitate a more benign interpretation bias. | Behavioural | Attention and interpretation biases modification |
Primary outcome
Social Anxiety Scale (LSAS) - diagnostic interview
Time frame: Expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols
LSAS is a 24-items clinician-administered scale developed for the assessment of fear and avoidance associated with social. 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
The Mini International Neuropsychiatric Interview (MINI).
Time frame: expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols
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 2 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Attention Bias Modification Treatment (ABMT), Interpretation Bias Modification (IBM) and Attention and Interpretive biases modification (CBM) in people with Social Phobia, run by Tel Aviv University 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 1 inclusion and 1 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 2 Dec 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Scale (LSAS) - diagnostic interview (time frame: Expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols). 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 2 Dec 2014; AzTrials last refreshed its copy on 6 Nov 2026.