Attention Disengagement Training for Social Phobia (SPAttn)

• ClinicalTrials.gov Identifier: NCT00684320
• Recruitment Status: Completed
• First Posted: May 26, 2008
• Results First Posted: May 1, 2014
• Last Update Posted: May 1, 2014
• Sponsor: San Diego State University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Nader Amir, San Diego State University

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Social Anxiety Disorder	Behavioral: Attention Disengagement Training (ADT); Behavioral: Placebo Condition	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Attention Disengagement Training for Social Phobia
• Study Start Date: September 2006
• Actual Primary Completion Date: August 2011
• Actual Study Completion Date: August 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 2 Placebo Condition (PC); 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.	Behavioral: Placebo Condition; 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.
Experimental: 1 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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Social Phobia and Anxiety Inventory [ Time Frame: Pre-Treatment, Post-Treatment (after 4 weeks of treatment) ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Principle DSM-IV-TR (APA, 2000) Diagnosis of social phobia - Generalized Type (GSP)

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, California

San Diego State University

San Diego, California, United States, 92120

Sponsors and Collaborators

San Diego State University

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Nader Amir, Ph.D.; SDSU/UCSD

More Information

• Responsible Party: Nader Amir, Professor, San Diego State University
• ClinicalTrials.gov Identifier: NCT00684320
• Other Study ID Numbers: R34MH073004-03 ( U.S. NIH Grant/Contract ); R34MH073004-03 ( U.S. NIH Grant/Contract )
• First Posted: May 26, 2008
• Results First Posted: May 1, 2014
• Last Update Posted: May 1, 2014
• Last Verified: April 2014

Keywords provided by Nader Amir, San Diego State University:

Social Anxiety Disorder; Information Processing; Attention Bias

Additional relevant MeSH terms:

Anxiety Disorders; Phobia, Social; Mental Disorders; Phobic Disorders