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Clinical Trials/NCT02136212
NCT02136212CompletedNot Applicable

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

University of California, San Diego2 sites in 1 country57 target enrollmentStarted: April 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
57
Locations
2
Primary Endpoint
Change from baseline in social connectedness (Social Connectedness Scale - Revised)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts 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.

Arms & Interventions

Approach-positive AAT

Experimental

Participants will receive 4 sessions over 2 weeks of a computerized AAT procedure designed to increase automatic approach responses for positive social cues.

Intervention: Approach-positive AAT (Behavioral)

Control AAT

Placebo Comparator

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.

Intervention: Control AAT (Behavioral)

Outcomes

Primary Outcomes

Change from baseline in social connectedness (Social Connectedness Scale - Revised)

Time Frame: 1 month

Change from pre- to post-assessment in social connectedness.

Change from baseline in positive affect (Positive and Negative Affect Schedule)

Time Frame: 1 month

Change from pre- to post-assessment in positive affect.

Secondary Outcomes

  • Change from baseline in social relationship functioning (Interpersonal Outcomes Scale)(1 month)
  • Change from baseline in social anxiety symptoms (Liebowitz Social Anxiety Scale)(1 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Charles Taylor

Assistant Professor

University of California, San Diego

Study Sites (2)

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