Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia

Not Applicable

Completed

• Conditions: Social Anxiety Disorder
• Interventions: Behavioral: Approach-positive AAT; Behavioral: Control AAT

• 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

Arm && Interventions

Group	Intervention	Description
Approach-positive AAT	Approach-positive AAT	Participants will receive 4 sessions over 2 weeks of a computerized AAT procedure designed to increase automatic approach responses for positive social cues.
Control AAT	Control AAT	Participants will receive 4 sessions over 2 weeks of a computerized AAT procedure in which there is no contingency between arm movement and positive social cues.

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