Clinical trial NCT02136212: Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia
Official title: Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia - New Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-05-12
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in positive affect (Positive and Negative Affect Schedule)
timeFrame: 1 month
measure: Change from baseline in social connectedness (Social Connectedness Scale - Revised)
timeFrame: 1 month
Secondary outcomes:
measure: Change from baseline in social relationship functioning (Interpersonal Outcomes Scale)
timeFrame: 1 month
measure: Change from baseline in social anxiety symptoms (Liebowitz Social Anxiety Scale)
timeFrame: 1 month
Other outcomes:
measure: 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)
timeFrame: 1 month
measure: Change from baseline in social anxiety disorder (SAD) related psychopathology, including depression and anhedonia.
timeFrame: 1 month
Locations:
city: San Diego
country: United States
facility: University of California, San Diego; Psychiatry Clinical Research
state: California
Study officials:
affiliation: University of California, San Diego
name: Charles T Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References: