Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia

Not Applicable

Completed

• Conditions: Social Anxiety Disorder

• Registration Number: NCT02136212
• Lead Sponsor: University of California, San Diego

Brief Summary

The purpose of this study is to test the effects of a computerized approach/avoidance training (AAT) procedure in a sample of individuals diagnosed with social anxiety disorder (SAD). The training procedure is designed to modify automatic approach responses for positive social stimuli. Previous research has shown that a single administration of approach-positive AAT influences social behavior in the laboratory. The goal of this study is to examine the effects of a four-session AAT procedure on measures of positive social-emotional functioning. The investigators hypothesize that individuals assigned to the approach-positive AAT condition will demonstrate larger increases in positive affect and improvements in social relationship functioning from pre- to post-assessment compared to those assigned to the control condition.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-12
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Age 18-55
• Principal psychiatric diagnosis of generalized social anxiety disorder
• Liebowitz Social Anxiety Scale (LSAS) score ≥ 60
• Ability to read and speak English sufficiently to complete study procedures

Exclusion Criteria

• History of psychosis, mania, or substance dependence
• Current severe medical disorder that requires inpatient treatment or frequent medical follow ups including but not limited to: unstable hypertension, unstable angina, unstable diabetes mellitus, unstable cardiac arrhythmias, transient ischemic attacks, severe coronary artery disease, severe peripheral vascular disease, severe hepato-gastro-intestinal disease, severe infectious disease (e.g. HIV), recurrent severe headache or migraine, fainting spells, seizures, and history of traumatic brain injury with loss of consciousness >30 minutes
• Current use of the following medications: antidepressants, benzodiazepines, antipsychotics, mood stabilizers, or other drugs that can acutely affect the hemodynamic response (methylphenidate and acetazolamide)
• Caffeine intake >10 cups/day or recent significant changes in consumption
• MRI exclusions, including claustrophobia, cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a metal worker/welder, history of eye surgery/eyes washed out because of metal, women who are or may be pregnant (determined by a positive pregnancy test), women using an intrauterine device, vision problems uncorrectable with lenses, claustrophobia, inability to lie still on one's back for 60 minutes; prior neurosurgery; older tattoos with metal dyes; unwillingness to remove nose, ear, tongue, or face rings.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in social connectedness (Social Connectedness Scale - Revised)	1 month	Change from pre- to post-assessment in social connectedness.
Change from baseline in positive affect (Positive and Negative Affect Schedule)	1 month	Change from pre- to post-assessment in positive affect.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in social relationship functioning (Interpersonal Outcomes Scale)	1 month	Change from pre- to post-assessment in frequency of social approach behaviors and relationship satisfaction.
Change from baseline in social anxiety symptoms (Liebowitz Social Anxiety Scale)	1 month	Change from pre- to post-assessment in social anxiety symptoms.

Trial Locations

Locations (1)

University of California, San Diego; Psychiatry Clinical Research; 🇺🇸 San Diego, California, United States