Attention Disengagement Training for Social Phobia

NCT00684320 | Completed Results DMC

• 1 other identifier: R34MH073004-03
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder

Keywords

Social Anxiety Disorder; Information Processing; Attention Bias

Outcome Measures

Primary Outcomes (1)

• 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

  Pre-Treatment, Post-Treatment (6 weeks)

Secondary Outcomes (1)

• Social Phobia and Anxiety Inventory

  Pre-Treatment, Post-Treatment (after 4 weeks of treatment)

Study Arms (2)

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.

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.

Behavioral: Attention Disengagement Training (ADT)

Interventions

Attention Disengagement Training (ADT) BEHAVIORAL

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.

1 Attention Disengagement Training (ADT)

Placebo Condition BEHAVIORAL

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.

2 Placebo Condition (PC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92120, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Nader Amir
• Organization: San Diego State University/University of California Joint Doctoral Program in Clinical Psychology

namir@mail.sdsu.edu

(619) 229-3740

Study Officials

• Nader Amir, Ph.D.

  SDSU/UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: September 1, 2006
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 1, 2014
• Results First Posted: May 1, 2014

Record last verified: 2014-04

Locations

US (1)