Back to resultsPositive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia
Primary Purpose
Social Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Approach-positive AAT
Control AAT
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder
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.
Sites / Locations
- University of California, San Diego; Psychiatry Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Approach-positive AAT
Control AAT
Arm Description
Participants will receive 4 sessions over 2 weeks of a computerized AAT procedure designed to increase automatic approach responses for positive social cues.
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.
Outcomes
Primary Outcome Measures
Change from baseline in positive affect (Positive and Negative Affect Schedule)
Change from pre- to post-assessment in positive affect.
Change from baseline in social connectedness (Social Connectedness Scale - Revised)
Change from pre- to post-assessment in social connectedness.
Secondary Outcome Measures
Change from baseline in social relationship functioning (Interpersonal Outcomes Scale)
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)
Change from pre- to post-assessment in social anxiety symptoms.
Full Information
NCT ID
NCT02136212
First Posted
May 8, 2014
Last Updated
August 31, 2017
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02136212
Brief Title
Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia
Official Title
Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia - New Data
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Approach-positive AAT
Arm Type
Experimental
Arm Description
Participants will receive 4 sessions over 2 weeks of a computerized AAT procedure designed to increase automatic approach responses for positive social cues.
Arm Title
Control AAT
Arm Type
Placebo Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Approach-positive AAT
Intervention Type
Behavioral
Intervention Name(s)
Control AAT
Primary Outcome Measure Information:
Title
Change from baseline in positive affect (Positive and Negative Affect Schedule)
Description
Change from pre- to post-assessment in positive affect.
Time Frame
1 month
Title
Change from baseline in social connectedness (Social Connectedness Scale - Revised)
Description
Change from pre- to post-assessment in social connectedness.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Change from baseline in social relationship functioning (Interpersonal Outcomes Scale)
Description
Change from pre- to post-assessment in frequency of social approach behaviors and relationship satisfaction.
Time Frame
1 month
Title
Change from baseline in social anxiety symptoms (Liebowitz Social Anxiety Scale)
Description
Change from pre- to post-assessment in social anxiety symptoms.
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
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)
Description
Change from pre- to post-assessment in neural activation during social reward processing.
Time Frame
1 month
Title
Change from baseline in social anxiety disorder (SAD) related psychopathology, including depression and anhedonia.
Description
Change from pre- to post-assessment in symptoms of depression and anhedonia
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles T Taylor, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego; Psychiatry Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92037-0855
Country
United States
12. IPD Sharing Statement
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Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia
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