Social Anxiety Disorder
Conditions
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.
Interventions
BEHAVIORALApproach-positive AAT
BEHAVIORALControl AAT
Sponsors
National Institute of Mental Health (NIMH)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in positive affect (Positive and Negative Affect Schedule) | 1 month | Change from pre- to post-assessment in positive affect. |
| Change from baseline in social connectedness (Social Connectedness Scale - Revised) | 1 month | Change from pre- to post-assessment in social connectedness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) | 1 month | Change from pre- to post-assessment in neural activation during social reward processing. |
| Change from baseline in social anxiety disorder (SAD) related psychopathology, including depression and anhedonia. | 1 month | Change from pre- to post-assessment in symptoms of depression and anhedonia |
Countries
United States
Outcome results
None listed