Social Anxiety DisorderNCT02136212
Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia
A study testing Approach-positive AAT in people with Social Anxiety Disorder, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Approach-positive AAT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego; Psychiatry Clinical Research
San Diego, California, 92037-0855
About this study
Official title: Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia - New Data
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
- Being tested
- Approach-positive AAT, Control AAT
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approach-positive AATBehavioural
Control AATBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control AAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in positive affect (Positive and Negative Affect Schedule)
Change from pre- to post-assessment in positive affect.
Measured: 1 month
Change from baseline in social connectedness (Social Connectedness Scale - Revised)
Change from pre- to post-assessment in social connectedness.
Measured: 1 month
Secondary outcomes (2)
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.
Measured: 1 month
Change from baseline in social anxiety symptoms (Liebowitz Social Anxiety Scale)
Change from pre- to post-assessment in social anxiety symptoms.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startApr 2013
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Charles Taylor, University of California, San Diego
- Investigators
- Charles T Taylor, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136212
- Sponsor's protocol ID
- 5R00MH090243
- Other IDs
- R00MH090243
- Status last verified
- Aug 2017
- First submitted
- 8 May 2014
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40657593Bomyea 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.
PubMed 36549342
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia - New Data
- ClinicalTrials.gov ID
- NCT02136212
- Acronym / sponsor ID
- 5R00MH090243
- Conditions
- Social Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Approach-positive AAT | Experimental | Behavioral: Approach-positive AATParticipants will receive 4 sessions over 2 weeks of a computerized AAT procedure designed to increase automatic approach responses for positive social cues. |
| Control AAT | Placebo comparator | Behavioral: Control AATParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Approach-positive AAT | Behavioural | Approach-positive AAT |
| Control AAT | Behavioural | Control AAT |
Primary outcome
Change from baseline in positive affect (Positive and Negative Affect Schedule)
Time frame: 1 month
Change from pre- to post-assessment in positive affect.
Change from baseline in social connectedness (Social Connectedness Scale - Revised)
Time frame: 1 month
Change from pre- to post-assessment in social connectedness.
2 secondary outcomes
Change from baseline in social relationship functioning (Interpersonal Outcomes Scale)
Time frame: 1 month
Change from baseline in social anxiety symptoms (Liebowitz Social Anxiety Scale)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Derived from this study: PubMed 40657593Hunt 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.
- Derived from this study: PubMed 36549342Bomyea 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.
Related trials for Social Anxiety Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
Not yet recruiting
Online Study on the Impact of a Self-Help Tool for Social Anxiety
Social Anxiety
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles T Taylor, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Approach-positive AAT in people with Social Anxiety Disorder, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in positive affect (Positive and Negative Affect Schedule) (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02136212, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.