Skip to main content
OpenTrials
Completed

NCT Number: NCT02136212

Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego; Psychiatry Clinical Research

San Diego, California, 92037-0855, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Approach-positive AAT

Behavioral

Control AAT

Behavioral

Primary outcomes

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

    Time frame: 1 month

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

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

    Time frame: 1 month

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

Secondary outcomes

  1. Change from baseline in social relationship functioning (Interpersonal Outcomes Scale)

    Time frame: 1 month

    Change from pre- to post-assessment in frequency of social approach behaviors and relationship satisfaction.

  2. Change from baseline in social anxiety symptoms (Liebowitz Social Anxiety Scale)

    Time frame: 1 month

    Change from pre- to post-assessment in social anxiety symptoms.

Other outcomes

  1. 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)

    Time frame: 1 month

    Change from pre- to post-assessment in neural activation during social reward processing.

  2. Change from baseline in social anxiety disorder (SAD) related psychopathology, including depression and anhedonia.

    Time frame: 1 month

    Change from pre- to post-assessment in symptoms of depression and anhedonia

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 12, 2014
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.