Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia

Social Anxiety Disorder Clinical Trial

Official title:

Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia - New Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136212
• Other study ID #: 5R00MH090243
• Secondary ID: R00MH090243
• Status: Completed
• Phase: N/A
• First received: May 8, 2014
• Last updated: August 31, 2017
• Start date: April 2013
• Est. completion date: September 2016

Study information

• Verified date: August 2017
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobic Disorders
• Social Anxiety Disorder

Intervention

Behavioral:
• Approach-positive AAT

• Control AAT

Locations

Country	Name	City	State
United States	University of California, San Diego; Psychiatry Clinical Research	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in blood oxygen level dependent (BOLD) response in the striatum, amygdala, and medial prefrontal cortex, as measured with functional magnetic resonance imaging (fMRI)	Change from pre- to post-assessment in neural activation during social reward processing.	1 month
Other	Change from baseline in social anxiety disorder (SAD) related psychopathology, including depression and anhedonia.	Change from pre- to post-assessment in symptoms of depression and anhedonia	1 month
Primary	Change from baseline in positive affect (Positive and Negative Affect Schedule)	Change from pre- to post-assessment in positive affect.	1 month
Primary	Change from baseline in social connectedness (Social Connectedness Scale - Revised)	Change from pre- to post-assessment in social connectedness.	1 month
Secondary	Change from baseline in social relationship functioning (Interpersonal Outcomes Scale)	Change from pre- to post-assessment in frequency of social approach behaviors and relationship satisfaction.	1 month
Secondary	Change from baseline in social anxiety symptoms (Liebowitz Social Anxiety Scale)	Change from pre- to post-assessment in social anxiety symptoms.	1 month