Social Anxiety DisorderSPAttnNCT00684320
Attention Disengagement Training for Social Phobia
A study testing Attention Disengagement Training (ADT) in people with Social Anxiety Disorder, run by San Diego State University at 1 site in United States.
Trial summary
Generalized Social Phobia is characterized by severe social anxiety that leads to functional impairment (Schneider et al., 1992). Despite its high prevalence, many individuals do not receive treatment or are unresponsive to current therapies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Attention Disengagement Training (ADT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Principle DSM-IV-TR (APA, 2000) Diagnosis of social phobia - Generalized Type (GSP)
Who cannot join
- No change in medication type or dosage twelve weeks prior to initiating treatment
- No current psychotherapy
- No evidence of suicidal intent
- No evidence of substance abuse in the last 6 months
- No evidence of current or past schizophrenia, bipolar disorder, or organic mental disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92120
About this study
Generalized Social Phobia is characterized by severe social anxiety that leads to functional impairment (Schneider et al., 1992). Despite its high prevalence, many individuals do not receive treatment or are unresponsive to current therapies. Thus there is a clear need to continue to develop highly effective and efficient treatments for social phobia. This three year project aims to test a computerized treatment for social phobia in a double-blind, placebo-controlled study designed to modify attention biases that may maintain anxiety.
Read the detailed description
Generalized Social Phobia (GSP) is characterized by severe social anxiety that leads to functional impairment (Schneider, et al., 1992). The prevalence of GSP is 13.3% (lifetime, Kessler, et al., 1994), ranking third among all psychiatric disorders. Despite its high prevalence, over 30% of individuals with social anxiety who need treatment do not receive treatment for a variety of reasons (e.g., afraid of what others might think, Olfson, et al., 2000). Additionally, 40% of individuals who present for treatment do not respond (39% Heimberg, et al., 1998; 42%, Liebowitz et al., 2005). Thus, there is a clear need to develop highly effective and efficient treatment procedures for social phobia. This three-year proposal aims to test a computerized treatment for social anxiety in a double-blind, placebo-controlled study. Specifically, research suggests that individuals with social phobia direct their attention toward socially-relevant negative information. Therefore, the treatment will focus on changing this attention bias and thereby alleviate symptoms of social anxiety. We present the results of a pilot study (n=26) in treatment seeking socially phobic individuals demonstrating the effectiveness of the treatment. A larger study would allow us to test the treatment and perhaps modify its component to increase its efficacy. The preliminary results of the pilot are encouraging. In brief, our intervention was effective in: a) changing biased attention in socially anxious individuals, b) generalizing this change in disengagement of attention from threat to other measures of attention disengagement, c) reduce symptoms of social anxiety as assessed by an independent rater, d) maintain a high rate of compliance (0% drop out in the pilot study), and e) maintain its effects in follow-up assessment up to one year. This efficient and efficacious techniques for changing attention bias in social phobia can provide a cost-effective and easy to administer treatment that is grounded in basic cognitive science and may help reduce suffering in individuals with GSP. We will test two hypotheses in this proposal. 1) Individuals with GSP completing the Attention Disengagement Training (ADT) will show a larger reduction in their symptoms compared to the placebo group on an interviewer measure of social anxiety (Liebowitz Social Anxiety Scale, LSAS). 2) Individuals with GSP completing ADT will show a larger reduction in their self-report of social anxiety symptoms compared to the placebo group
- Conditions
- Social Anxiety Disorder
- Being tested
- Attention Disengagement Training (ADT), Placebo Condition
- Keywords
- Social Anxiety Disorder, Information Processing, Attention Bias
- 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 Disengagement Training (ADT)Behavioural
Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
Placebo ConditionBehavioural
The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe.
| Study group | Role | What they receive |
|---|---|---|
| 2 Placebo Condition (PC) | Active comparator | The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe. Receives: Behavioral: Placebo Condition |
| 1 Attention Disengagement Training (ADT) | Experimental | Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face. Receives: Behavioral: Attention Disengagement Training (ADT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liebowitz Social Anxiety Scale (LSAS)
Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms
Measured: Pre-Treatment, Post-Treatment (6 weeks)
Secondary outcomes (1)
Social Phobia and Anxiety Inventory
Our primary self-report outcome measure was the Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, \& Stanley, 1989), which consists of 45 items assessing the cognitive, behavioral, and somatic dimensions of SP. SPAI scores range from 45 to 315, with higher scores indicating more severe symptoms. This measure has strong psychometric properties (Turner et al., 1989) and has been widely used in previous treatment outcome research in SP (e.g., Clark et al., 2006).
Measured: Pre-Treatment, Post-Treatment (after 4 weeks of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startSep 2006
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Nader Amir, San Diego State University
- Investigators
- Nader Amir, Ph.D., Principal investigator, SDSU/UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684320
- Sponsor's protocol ID
- R34MH073004-03
- Other IDs
- R34MH073004-03
- Acronym
- SPAttn
- Status last verified
- Apr 2014
- First submitted
- 22 May 2008
- Last updated
- 1 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Disengagement Training for Social Phobia
- ClinicalTrials.gov ID
- NCT00684320
- Acronym / sponsor ID
- SPAttn / R34MH073004-03
- Conditions
- Social Anxiety Disorder
- Keywords
- Social Anxiety Disorder, Information Processing, Attention Bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Posted 1 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Generalized Social Phobia is characterized by severe social anxiety that leads to functional impairment (Schneider et al., 1992). Despite its high prevalence, many individuals do not receive treatment or are unresponsive to current therapies. Thus there is a clear need to continue to develop highly effective and efficient treatments for social phobia. This three year project aims to test a computerized treatment for social phobia in a double-blind, placebo-controlled study designed to modify attention biases that may maintain anxiety.
Detailed description
Generalized Social Phobia (GSP) is characterized by severe social anxiety that leads to functional impairment (Schneider, et al., 1992). The prevalence of GSP is 13.3% (lifetime, Kessler, et al., 1994), ranking third among all psychiatric disorders. Despite its high prevalence, over 30% of individuals with social anxiety who need treatment do not receive treatment for a variety of reasons (e.g., afraid of what others might think, Olfson, et al., 2000). Additionally, 40% of individuals who present for treatment do not respond (39% Heimberg, et al., 1998; 42%, Liebowitz et al., 2005). Thus, there is a clear need to develop highly effective and efficient treatment procedures for social phobia. This three-year proposal aims to test a computerized treatment for social anxiety in a double-blind, placebo-controlled study. Specifically, research suggests that individuals with social phobia direct their attention toward socially-relevant negative information. Therefore, the treatment will focus on changing this attention bias and thereby alleviate symptoms of social anxiety. We present the results of a pilot study (n=26) in treatment seeking socially phobic individuals demonstrating the effectiveness of the treatment. A larger study would allow us to test the treatment and perhaps modify its component to increase its efficacy. The preliminary results of the pilot are encouraging. In brief, our intervention was effective in: a) changing biased attention in socially anxious individuals, b) generalizing this change in disengagement of attention from threat to other measures of attention disengagement, c) reduce symptoms of social anxiety as assessed by an independent rater, d) maintain a high rate of compliance (0% drop out in the pilot study), and e) maintain its effects in follow-up assessment up to one year. This efficient and efficacious techniques for changing attention bias in social phobia can provide a cost-effective and easy to administer treatment that is grounded in basic cognitive science and may help reduce suffering in individuals with GSP. We will test two hypotheses in this proposal. 1) Individuals with GSP completing the Attention Disengagement Training (ADT) will show a larger reduction in their symptoms compared to the placebo group on an interviewer measure of social anxiety (Liebowitz Social Anxiety Scale, LSAS). 2) Individuals with GSP completing ADT will show a larger reduction in their self-report of social anxiety symptoms compared to the placebo group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 Placebo Condition (PC) | Active comparator | Behavioral: Placebo ConditionThe placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe. |
| 1 Attention Disengagement Training (ADT) | Experimental | Behavioral: Attention Disengagement Training (ADT)Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Principle DSM-IV-TR (APA, 2000) Diagnosis of social phobia - Generalized Type (GSP)
Key exclusion criteria (5 listed)
- No change in medication type or dosage twelve weeks prior to initiating treatment
- No current psychotherapy
- No evidence of suicidal intent
- No evidence of substance abuse in the last 6 months
- No evidence of current or past schizophrenia, bipolar disorder, or organic mental disorder
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 Disengagement Training (ADT)Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face. | Behavioural | 1 Attention Disengagement Training (ADT) |
| Placebo ConditionThe placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe. | Behavioural | 2 Placebo Condition (PC) |
Primary outcome
Liebowitz Social Anxiety Scale (LSAS)
Time frame: Pre-Treatment, Post-Treatment (6 weeks)
Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms
1 secondary outcome
Social Phobia and Anxiety Inventory
Time frame: Pre-Treatment, Post-Treatment (after 4 weeks of treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nader Amir, Ph.D. principal investigator
SDSU/UCSD
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 Disengagement Training (ADT) in people with Social Anxiety Disorder, run by San Diego State University at 1 site in United States.
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 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 1 May 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 United States. 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?
Yes. Results are posted in the registry (first posted 1 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Liebowitz Social Anxiety Scale (LSAS) (time frame: Pre-Treatment, Post-Treatment (6 weeks)). 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 1 May 2014.