Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia

Study Overview
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Brief Summary
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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.

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

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Behavioral: Approach-positive AAT
* Behavioral: Control AAT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Approach-positive AAT<br>Participants will receive 4 sessions over 2 weeks of a computerized AAT procedure designed to increase automatic approach responses for positive social cues. | Behavioral: Approach-positive AAT<br> <br> |
| Placebo Comparator: Control AAT<br>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. | Behavioral: Control AAT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change from baseline in social anxiety symptoms (Liebowitz Social Anxiety Scale) | Change from pre- to post-assessment in social anxiety symptoms. | 1 month |