Social Anxiety DisorderABMT+CBGTNCT02338453
Attention Bias Modification Treatment (ABMT) and Cognitive-Behavioral Group Therapy (CBGT) in Social Anxiety Disorder
A study testing Active Attention Bias Modification Treatment in people with Social Anxiety Disorder, run by Yair Bar-Haim at 2 sites in Israel.
Trial summary
This RCT examines the effectiveness of Attention Bias Modification Treatment (ABMT) as an augment to Cognitive-Behavioral Group Treatment (CBGT) for Social Anxiety Disorder (SAD) in adults. It is expected that ABMT vs. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Active Attention Bias Modification Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesIsrael
- Study dates
- Mar 2015to Mar 2017
- 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
- A signed consent form
- Men and women between the ages of 18 and 60.
- Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV
- A minimum of a 1-year duration of SP
- SP as the primary diagnosis: In cases of co-morbidity, SP will be deemed as the most distressing and clinically significant condition among the co-morbid disorders
- Stable pharmacotherapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of CBGT.
Who cannot join
- Psychotic episode in the past or the present time.
- Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).
- Another psychotherapeutic treatment during the study.
- Usage of neuroleptic medication.
- Change in medication status during the study.
- Substantial usage of drugs or alcohol in the present time.
- Poor judgment capacity (i.e., children under 18 and special populations).
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Geha Mental Health Center
Petah Tikva
Tel-Aviv University
Tel Aviv
About this study
Official title: Examining the Effects of a Combined Attention Bias Modification Treatment (ABMT) and Cognitive-Behavioral Group Therapy (CBGT) for Social Anxiety Disorder
This RCT examines the effectiveness of Attention Bias Modification Treatment (ABMT) as an augment to Cognitive-Behavioral Group Treatment (CBGT) for Social Anxiety Disorder (SAD) in adults. It is expected that ABMT vs. control training condition would achieve better therapeutic outcomes as indicated reduction in symptoms.
Participants from three groups (estimated 40 patients) will be offered to participate in the study
Read the detailed description
Outpatients seeking treatment for Social Anxiety Disorder (SAD) at Geha anxiety-disorders clinic will be randomized into two groups (ABMT+CBGT; placebo control+CBGT). One group will undergo an Attention Bias Modification Treatment (ABMT) aimed at diverting attention away from socially-threatening stimuli. The second group will receive a placebo-control not designed to affect attention. Both groups will also undergo a standard Cognitive-Behavioral Group Treatment (CBGT) comprising 18 weekly sessions of 1.5-hr duration (along the lines of Heimberg, Juster, Hope \& Mattia 1995 and Clark \& Wells 1995). Symptoms and attention bias measures will be taken at three time points: Pre-treatment, Post-treatment,and at 3-month follow-up.
The study includes the following steps: a) initial assessment of participants' psychopathology and symptom levels; b) attention bias measurement; c) 8 sessions of ABMT/placebo control delivered as part of the CBGT sessions; d) two booster ABMT/Placebo treatments will be delivered at sessions 13 and 16 of the CBGT protocol. e) post-treatment assessment will include symptom and attention bias assessments. Finally, f) a three-month follow up assessment.
The goal of the study is to to test the effectiveness of ABMT as an add-on to established CBGT protocol for social anxiety disorder.
- Conditions
- Social Anxiety Disorder
- Being tested
- Active Attention Bias Modification Treatment, Placebo Attention Bias Modification Treatment
- Keywords
- Social Anxiety, Attention Modification, Dot-Probe, GCBT
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Attention Bias Modification TreatmentBehavioural
Also called Active ABMT
Attention bias is modified using a dot-probe task. Each trial begins with a fixation cross presented in the center of the screen for 500 ms. Next, participants are presented with two stimuli depicting two faces of the same individual for 500 ms, either of two neutral faces or with one neutral face and one disgust face (i.e., the socially-threatening stimulus). Then, one of two optional probes appears in the location former occupied by one of the faces. Participants are instructed to discriminate as fast as possible between the two variants of the probe, without compromising accuracy, by pressing on two corresponding keys. The probe remains on the screen until the participant responds, after which the next trial commences. This protocol is designed to divert attention away from socially-threatening stimuli as in 80% of trials the probe appears in the location formerly occupied by the neutral face. The remaining 20% of trials include two neutral faces, with no predictive value
Placebo Attention Bias Modification TreatmentBehavioural
Also called Placebo ABMT
the Placebo ABMT is similar to the active ABMT except that this protocol is not designed to divert attention away from or toward socially-threatening stimuli as in 40% of trials the probe appears in the location formerly occupied by the neutral face and in 40% it appears in the location formally occupied by the threatening face. The remaining 20% of trials include two neutral faces
| Study group | Role | What they receive |
|---|---|---|
| Attention Bias Modification Treatment | Active comparator | Participants will receive an attention bias modification protocol designed to divert attention away from socially-threatening stimuli via repeated trials of a dot-probe task. Receives: Behavioral: Active Attention Bias Modification Treatment |
| placebo-control condition | Placebo comparator | Participants will receive an placebo control protocol using the same task and stimuli but not designed to change attention patterns Receives: Behavioral: Placebo Attention Bias Modification Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview (LSAS; Liebowitz, 1987) scores
The LSAS is a 24-item scale, each item corresponding to a situation selected on the basis of clinical experience. Each item is rated on a severity scale ranging from 0 to 3 with regard to the passing week, measuring separately two components of social anxiety, specifically, fear/anxiety and avoidance of social interaction and performance situations. Although the assessor may request and ask for further detail and adjust the rating based on clinical experience, this option is not often exercised, and inter-rater agreement is not considered to be a relevant concern (Safren et al., 1999). It has been shown to have strong psychometric properties, including high internal consistency, strong convergent and discriminative validity and high test-retest reliability (Fresco et al., 2001; Heimberg et al., 1999)
Measured: post treatment (18 weeks) and 3-month follow up
Secondary outcomes (1)
Change from baseline - the Social Phobia Inventory (SPIN; Connor et al., 2000) scores
This is a 17-item self-report measure of social anxiety evaluating fear, avoidance and physiological discomfort. Each item is rated on scale ranging from 0 to 4 with a possible total score of 68. The SPIN has been used in clinical and nonclinical samples and its psychometric properties have been found to be sound (Connor et al., 2000).
Measured: post treatment (18 weeks) and 3-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yair Bar-Haim
- Sponsor type
- University, hospital or other
- Collaborators
- Geha Mental Health Center
- Responsible party
- Sponsor-investigator, Yair Bar-Haim, Tel Aviv University
- Investigators
- Haggai Hermesh, PhD, Study chair, Geha Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338453
- Sponsor's protocol ID
- TauGeha-001-15
- Acronym
- ABMT+CBGT
- Status last verified
- Aug 2017
- First submitted
- 7 Jan 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Shechner T, Rimon-Chakir A, Britton JC, Lotan D, Apter A, Bliese PD, Pine DS, Bar-Haim Y. Attention bias modification treatment augmenting effects on cognitive behavioral therapy in children with anxiety: randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Jan;53(1):61-71. doi: 10.1016/j.jaac.2013.09.016. Epub 2013 Oct 10.
PubMed 24342386
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of a Combined Attention Bias Modification Treatment (ABMT) and Cognitive-Behavioral Group Therapy (CBGT) for Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT02338453
- Acronym / sponsor ID
- ABMT+CBGT / TauGeha-001-15
- Conditions
- Social Anxiety Disorder
- Keywords
- Social Anxiety, Attention Modification, Dot-Probe, GCBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yair Bar-HaimUniversity, hospital or other
- Collaborators
- Geha Mental Health Center
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 14 Jan 2015 (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.
This RCT examines the effectiveness of Attention Bias Modification Treatment (ABMT) as an augment to Cognitive-Behavioral Group Treatment (CBGT) for Social Anxiety Disorder (SAD) in adults. It is expected that ABMT vs. control training condition would achieve better therapeutic outcomes as indicated reduction in symptoms.
Participants from three groups (estimated 40 patients) will be offered to participate in the study
Detailed description
Outpatients seeking treatment for Social Anxiety Disorder (SAD) at Geha anxiety-disorders clinic will be randomized into two groups (ABMT+CBGT; placebo control+CBGT). One group will undergo an Attention Bias Modification Treatment (ABMT) aimed at diverting attention away from socially-threatening stimuli. The second group will receive a placebo-control not designed to affect attention. Both groups will also undergo a standard Cognitive-Behavioral Group Treatment (CBGT) comprising 18 weekly sessions of 1.5-hr duration (along the lines of Heimberg, Juster, Hope \& Mattia 1995 and Clark \& Wells 1995). Symptoms and attention bias measures will be taken at three time points: Pre-treatment, Post-treatment,and at 3-month follow-up.
The study includes the following steps: a) initial assessment of participants' psychopathology and symptom levels; b) attention bias measurement; c) 8 sessions of ABMT/placebo control delivered as part of the CBGT sessions; d) two booster ABMT/Placebo treatments will be delivered at sessions 13 and 16 of the CBGT protocol. e) post-treatment assessment will include symptom and attention bias assessments. Finally, f) a three-month follow up assessment.
The goal of the study is to to test the effectiveness of ABMT as an add-on to established CBGT protocol for social anxiety disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Bias Modification Treatment | Active comparator | Behavioral: Active Attention Bias Modification TreatmentParticipants will receive an attention bias modification protocol designed to divert attention away from socially-threatening stimuli via repeated trials of a dot-probe task. |
| placebo-control condition | Placebo comparator | Behavioral: Placebo Attention Bias Modification TreatmentParticipants will receive an placebo control protocol using the same task and stimuli but not designed to change attention patterns |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A signed consent form
- Men and women between the ages of 18 and 60.
- Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV
- A minimum of a 1-year duration of SP
- SP as the primary diagnosis: In cases of co-morbidity, SP will be deemed as the most distressing and clinically significant condition among the co-morbid disorders
Key exclusion criteria (7 listed)
- Psychotic episode in the past or the present time.
- Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).
- Another psychotherapeutic treatment during the study.
- Usage of neuroleptic medication.
- Change in medication status during the study.
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 |
|---|---|---|
| Active Attention Bias Modification TreatmentAlso: Active ABMTAttention bias is modified using a dot-probe task. Each trial begins with a fixation cross presented in the center of the screen for 500 ms. Next, participants are presented with two stimuli depicting two faces of the same individual for 500 ms, either of two neutral faces or with one neutral face and one disgust face (i.e., the socially-threatening stimulus). Then, one of two optional probes appears in the location former occupied by one of the faces. Participants are instructed to discriminate as fast as possible between the two variants of the probe, without compromising accuracy, by pressing on two corresponding keys. The probe remains on the screen until the participant responds, after which the next trial commences. This protocol is designed to divert attention away from socially-threatening stimuli as in 80% of trials the probe appears in the location formerly occupied by the neutral face. The remaining 20% of trials include two neutral faces, with no predictive value | Behavioural | Attention Bias Modification Treatment |
| Placebo Attention Bias Modification TreatmentAlso: Placebo ABMTthe Placebo ABMT is similar to the active ABMT except that this protocol is not designed to divert attention away from or toward socially-threatening stimuli as in 40% of trials the probe appears in the location formerly occupied by the neutral face and in 40% it appears in the location formally occupied by the threatening face. The remaining 20% of trials include two neutral faces | Behavioural | placebo-control condition |
Primary outcome
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview (LSAS; Liebowitz, 1987) scores
Time frame: post treatment (18 weeks) and 3-month follow up
The LSAS is a 24-item scale, each item corresponding to a situation selected on the basis of clinical experience. Each item is rated on a severity scale ranging from 0 to 3 with regard to the passing week, measuring separately two components of social anxiety, specifically, fear/anxiety and avoidance of social interaction and performance situations. Although the assessor may request and ask for further detail and adjust the rating based on clinical experience, this option is not often exercised, and inter-rater agreement is not considered to be a relevant concern (Safren et al., 1999). It has been shown to have strong psychometric properties, including high internal consistency, strong convergent and discriminative validity and high test-retest reliability (Fresco et al., 2001; Heimberg et al., 1999)
1 secondary outcome
Change from baseline - the Social Phobia Inventory (SPIN; Connor et al., 2000) scores
Time frame: post treatment (18 weeks) and 3-month 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 22 Aug 2017.
- Background: PubMed 24342386Shechner T, Rimon-Chakir A, Britton JC, Lotan D, Apter A, Bliese PD, Pine DS, Bar-Haim Y. Attention bias modification treatment augmenting effects on cognitive behavioral therapy in children with anxiety: randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Jan;53(1):61-71. doi: 10.1016/j.jaac.2013.09.016. Epub 2013 Oct 10.
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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.
Haggai Hermesh, PhD study chair
Geha Mental Health Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Attention Bias Modification Treatment in people with Social Anxiety Disorder, run by Yair Bar-Haim at 2 sites 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 6 inclusion and 7 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview (LSAS; Liebowitz, 1987) scores (time frame: post treatment (18 weeks) and 3-month follow up). 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 NCT02338453, which also lists 1 linked publication.
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 22 Aug 2017.