Social AnxietyNCT03743571
Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation
A study testing transcranial direct current stimulation and exposure therapy in people with Social Anxiety, run by University of Nevada, Reno at 1 site in United States.
Trial summary
This study will examine whether transcranial direct current stimulation (tDCS) can be used to improve outcomes from exposure therapy for social anxiety disorder, and facilitate extinction of fear responding toward individuals outside one's own ethnic group (i.e., ethnic out-group members). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety
- What is being tested?
- transcranial direct current stimulation and exposure therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2019to 5 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older (adult)
- Enrolled in higher education (post-high school)
- Elevated public speaking anxiety as indicated by self-report questions
- NOT currently receiving in exposure therapy for social anxiety
Who cannot join
- History of seizure or any other neurological diagnosis
- Has any metal in their skull (plates, steel sutures, etc.)
- Participant is currently taking anti-convulsant, sedative/hypnotic, or antipsychotic medications
- Participant is pregnant
- Participant has already participated in a prior tDCS/tACS study on the same day as study visit 1 (which will involve either placebo or active/anodal tDCS stimulation)
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine whether transcranial direct current stimulation (tDCS) can be used to improve outcomes from exposure therapy for social anxiety disorder, and facilitate extinction of fear responding toward individuals outside one's own ethnic group (i.e., ethnic out-group members).
Read the detailed description
Although exposure therapy is among the most powerful treatment techniques for social anxiety, many individuals do not achieve full remission. Furthermore, some research suggests that fear responding toward ethnic out-group members may be more resistant to extinction. Enhancing activation of the mPFC during exposure therapy may improve overall response to treatment, and also facilitate extinction of fear toward ethic out-groups. Researchers have found that greater mPFC activation during exposure therapy is associated with better outcomes, and that transcranial direct current stimulation (tDCS) can be used enhance learning and cognition with no known serious adverse effects. This study will therefore examine whether active/anodal (versus sham) tDCS targeting the mPFC (a) enhances overall reductions in social anxiety symptoms, and (b) facilitates extinction of fear responding toward ethnic/racial out-groups for both Latino and Caucasian/non-Latino participants. Participants will receive either active/anodal tDCS or sham tDCS during a brief exposure therapy intervention involving public speaking in a Virtual Reality (VR) environment. The public speaking audience in the VR environment will alternate between audiences that are either matched or unmatched to the participant's ethnicity (in a randomly assigned order). Participants' fear reactivity will be assessed with behavioral, physiological, and subjective measures at baseline, post-treatment, and follow-up.
- Conditions
- Social Anxiety
- Being tested
- transcranial direct current stimulation, exposure therapy
- Keywords
- social anxiety, transcranial direct current stimulation, exposure therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
tDCS will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy
exposure therapyBehavioural
participants will complete one session of exposure therapy for fear of public speaking, which will involve providing speeches to audiences in virtual reality
| Study group | Role | What they receive |
|---|---|---|
| anodal tDCS during exposure | Active comparator | anodal transcranial direct current stimulation (2mA) will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy Receives: Device: transcranial direct current stimulation; Behavioral: exposure therapy |
| sham tDCS during exposure | Sham comparator | sham transcranial direct current stimulation will be applied over EEG coordinate FpZ during exposure therapy at a level that provides the physical sensations of tDCS but which is non-therapeutic Receives: Device: transcranial direct current stimulation; Behavioral: exposure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
BAT: Matched Audience, Speech Duration
During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak fear).
*This outcome report is for the duration of the matched BAT. The total possible range of the speech is from 0 to 300 seconds. Longer speech durations indicate greater approach, which is a better outcome.*
Measured: follow-up, one month after baseline assessment
BAT: Matched Audience, Anticipated Anxiety
During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak anxiety).
*This outcome report is for anticipated anxiety during the matched BAT. The total possible range of the subjective rating is from 0 to 100. Higher ratings indicate greater anxiety, which is a worse outcome.*
Measured: follow-up, one month after baseline assessment
BAT: Matched Audience, Peak Anxiety
During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak anxiety).
*This outcome report is for peak anxiety during the matched BAT. The total possible range of the subjective rating is from 0 to 100. Higher ratings indicate greater anxiety, which is a worse outcome.*
Measured: follow-up, one month after baseline assessment
BAT: Unmatched Audience, Speech Duration
During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak fear).
*This outcome report is for the duration of the unmatched BAT. The total possible range of the speech is from 0 to 300 seconds. Longer speech durations indicate greater approach, which is a better outcome.*
Measured: follow-up, one month after baseline assessment
BAT: Unmatched Audience, Anticipated Anxiety
During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak anxiety).
*This outcome report is for anticipated anxiety during the unmatched BAT. The total possible range of the subjective rating is from 0 to 100. Higher ratings indicate greater anxiety, which is a worse outcome.*
Measured: follow-up, one month after baseline assessment
BAT: Unmatched Audience, Peak Anxiety
During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak anxiety).
*This outcome report is for peak anxiety during the unmatched BAT. The total possible range of the subjective rating is from 0 to 100. Higher ratings indicate greater anxiety, which is a worse outcome.*
Measured: follow-up, one month after baseline assessment
Secondary outcomes (3)
Personal Report of Public Speaking Anxiety
Participants will complete the Personal Report of Public Speaking Anxiety (PRPSA), a 34-item questionnaire that assesses public speaking anxiety. The items are sum scored, and totals range from 34 to 170, with higher scores indicating higher levels of public speaking anxiety.
Measured: follow-up, one month after baseline assessment
Positive Self Statements
Participants will complete the Positive Self Statements subscale of the Self Statements During Public Speaking Scale (SSPS). The SSPS is 10-item questionnaire that asses both positive and negative self statements associated with public speaking. The items within each of the two subscales are summed, with total scores ranging from 0 to 25 for each subscale, and higher scores indicating higher levels of agreement with positive or negative self statements, respectively. Higher scores on the positive self statements indicate less anxiety.
Measured: follow-up, one month after baseline assessment
Negative Self Statements
Participants will complete the Negative Self Statements subscale of the Self Statements During Public Speaking Scale (SSPS). The SSPS is 10-item questionnaire that asses both positive and negative self statements associated with public speaking. The items within each of the two subscales are summed, with total scores ranging from 0 to 25 for each subscale, and higher scores indicating higher levels of agreement with positive or negative self statements, respectively. Higher scores on the negative self statements indicate more anxiety.
Measured: follow-up, one month after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start2 Apr 2019
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Why it stopped: recruitment terminated due to COVID-related social distancing requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomly assigned to receive either sham or anodal (2 mA) tDCS targeting the mPFC during exposure therapy for public speaking anxiety.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Lancaster, University of Nevada, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743571
- Sponsor's protocol ID
- 1222479-2
- Status last verified
- Aug 2024
- First submitted
- 9 Nov 2018
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study protocols and de-identified data will be shared at the request of other researchers.
Publications
McDonald MA, Meckes SJ, Shires J, Berryhill ME, Lancaster CL. Augmenting Virtual Reality Exposure Therapy for Social and Intergroup Anxiety With Transcranial Direct Current Stimulation. J ECT. 2024 Mar 1;40(1):51-60. doi: 10.1097/YCT.0000000000000967. Epub 2023 Nov 24.
PubMed 38009966
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT03743571
- Acronym / sponsor ID
- 1222479-2
- Conditions
- Social Anxiety
- Keywords
- social anxiety, transcranial direct current stimulation, exposure therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment terminated due to COVID-related social distancing requirements
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Posted 22 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine whether transcranial direct current stimulation (tDCS) can be used to improve outcomes from exposure therapy for social anxiety disorder, and facilitate extinction of fear responding toward individuals outside one's own ethnic group (i.e., ethnic out-group members).
Detailed description
Although exposure therapy is among the most powerful treatment techniques for social anxiety, many individuals do not achieve full remission. Furthermore, some research suggests that fear responding toward ethnic out-group members may be more resistant to extinction. Enhancing activation of the mPFC during exposure therapy may improve overall response to treatment, and also facilitate extinction of fear toward ethic out-groups. Researchers have found that greater mPFC activation during exposure therapy is associated with better outcomes, and that transcranial direct current stimulation (tDCS) can be used enhance learning and cognition with no known serious adverse effects. This study will therefore examine whether active/anodal (versus sham) tDCS targeting the mPFC (a) enhances overall reductions in social anxiety symptoms, and (b) facilitates extinction of fear responding toward ethnic/racial out-groups for both Latino and Caucasian/non-Latino participants. Participants will receive either active/anodal tDCS or sham tDCS during a brief exposure therapy intervention involving public speaking in a Virtual Reality (VR) environment. The public speaking audience in the VR environment will alternate between audiences that are either matched or unmatched to the participant's ethnicity (in a randomly assigned order). Participants' fear reactivity will be assessed with behavioral, physiological, and subjective measures at baseline, post-treatment, and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive either sham or anodal (2 mA) tDCS targeting the mPFC during exposure therapy for public speaking anxiety.
| Arm | Type | Receives |
|---|---|---|
| anodal tDCS during exposure | Active comparator | Device: transcranial direct current stimulation, Behavioral: exposure therapyanodal transcranial direct current stimulation (2mA) will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy |
| sham tDCS during exposure | Sham comparator | Device: transcranial direct current stimulation, Behavioral: exposure therapysham transcranial direct current stimulation will be applied over EEG coordinate FpZ during exposure therapy at a level that provides the physical sensations of tDCS but which is non-therapeutic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older (adult)
- Enrolled in higher education (post-high school)
- Elevated public speaking anxiety as indicated by self-report questions
- NOT currently receiving in exposure therapy for social anxiety
Key exclusion criteria (5 listed)
- History of seizure or any other neurological diagnosis
- Has any metal in their skull (plates, steel sutures, etc.)
- Participant is currently taking anti-convulsant, sedative/hypnotic, or antipsychotic medications
- Participant is pregnant
- Participant has already participated in a prior tDCS/tACS study on the same day as study visit 1 (which will involve either placebo or active/anodal tDCS stimulation)
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 |
|---|---|---|
| transcranial direct current stimulationtDCS will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy | Device | anodal tDCS during exposure, sham tDCS during exposure |
| exposure therapyparticipants will complete one session of exposure therapy for fear of public speaking, which will involve providing speeches to audiences in virtual reality | Behavioural | anodal tDCS during exposure, sham tDCS during exposure |
Primary outcome
BAT: Matched Audience, Speech Duration
Time frame: follow-up, one month after baseline assessment
During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak fear). *This outcome report is for the duration of the matched BAT. The total possible range of the speech is from 0 to 300 seconds. Longer speech durations indicate greater approach, which is a better outcome.*
BAT: Matched Audience, Anticipated Anxiety
Time frame: follow-up, one month after baseline assessment
During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak anxiety). *This outcome report is for anticipated anxiety during the matched BAT. The total possible range of the subjective rating is from 0 to 100. Higher ratings indicate greater anxiety, which is a worse outcome.*
BAT: Matched Audience, Peak Anxiety
Time frame: follow-up, one month after baseline assessment
During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak anxiety). *This outcome report is for peak anxiety during the matched BAT. The total possible range of the subjective rating is from 0 to 100. Higher ratings indicate greater anxiety, which is a worse outcome.*
BAT: Unmatched Audience, Speech Duration
Time frame: follow-up, one month after baseline assessment
During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak fear). *This outcome report is for the duration of the unmatched BAT. The total possible range of the speech is from 0 to 300 seconds. Longer speech durations indicate greater approach, which is a better outcome.*
BAT: Unmatched Audience, Anticipated Anxiety
Time frame: follow-up, one month after baseline assessment
During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak anxiety). *This outcome report is for anticipated anxiety during the unmatched BAT. The total possible range of the subjective rating is from 0 to 100. Higher ratings indicate greater anxiety, which is a worse outcome.*
BAT: Unmatched Audience, Peak Anxiety
Time frame: follow-up, one month after baseline assessment
During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak anxiety). *This outcome report is for peak anxiety during the unmatched BAT. The total possible range of the subjective rating is from 0 to 100. Higher ratings indicate greater anxiety, which is a worse outcome.*
3 secondary outcomes
Personal Report of Public Speaking Anxiety
Time frame: follow-up, one month after baseline assessment
Positive Self Statements
Time frame: follow-up, one month after baseline assessment
Negative Self Statements
Time frame: follow-up, one month after baseline assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38009966McDonald MA, Meckes SJ, Shires J, Berryhill ME, Lancaster CL. Augmenting Virtual Reality Exposure Therapy for Social and Intergroup Anxiety With Transcranial Direct Current Stimulation. J ECT. 2024 Mar 1;40(1):51-60. doi: 10.1097/YCT.0000000000000967. Epub 2023 Nov 24.
- Individual participant dataSharing planned: No. Study protocols and de-identified data will be shared at the request of other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation and exposure therapy in people with Social Anxiety, run by University of Nevada, Reno 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: stopped early, as of the sponsor's last update on 8 Apr 2026. 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?
Yes. Results are posted in the registry (first posted 22 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
BAT: Matched Audience, Speech Duration (time frame: follow-up, one month after baseline assessment). The study lists 6 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 NCT03743571, which also lists 1 linked publication.
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 8 Apr 2026.