Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia

NCT02136212 | Completed

• 2 other identifiers: 5R00MH090243R00MH090243
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Other Outcomes (2)

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

  1 month

Study Arms (2)

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.

Behavioral: Approach-positive AAT

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.

Behavioral: Control AAT

Interventions

Approach-positive AAT BEHAVIORAL

Approach-positive AAT

Control AAT BEHAVIORAL

Control AAT

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California, San Diego; Psychiatry Clinical Research

San Diego, California, 92037-0855, United States

Location

Related Publications (2)

• Hunt C, Caudle MM, Paulus MP, Stein MB, Taylor CT, Bomyea J. Reduced neural activation during positive social approach is associated with better response to approach avoidance training for social anxiety disorder. J Mood Anxiety Disord. 2025 Feb 7;10:100110. doi: 10.1016/j.xjmad.2025.100110. eCollection 2025 Jun.

  PMID: 40657593 DERIVED

• Bomyea J, Sweet A, Davey DK, Boland M, Paulus MP, Stein MB, Taylor CT. Randomized controlled trial of computerized approach/avoidance training in social anxiety disorder: Neural and symptom outcomes. J Affect Disord. 2023 Mar 1;324:36-45. doi: 10.1016/j.jad.2022.12.054. Epub 2022 Dec 19.

  PMID: 36549342 DERIVED

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Charles T Taylor, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 12, 2014
• Study Start: April 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 1, 2017

Record last verified: 2017-08

Locations

US (1)