Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia

NCT ID: NCT02136212

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Approach-positive AAT

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

Group Type: EXPERIMENTAL

Approach-positive AAT

Intervention Type: BEHAVIORAL

Control AAT

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.

Group Type: PLACEBO_COMPARATOR

Control AAT

Intervention Type: BEHAVIORAL

Interventions

Approach-positive AAT

Intervention Type: BEHAVIORAL

Control AAT

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Charles Taylor

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles T Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego; Psychiatry Clinical Research

San Diego, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40657593 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36549342 (View on PubMed)

Other Identifiers

R00MH090243

Identifier Type: NIH

Identifier Source: secondary_id

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5R00MH090243

Identifier Type: NIH

Identifier Source: org_study_id

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