Clinical trial NCT03743571: Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation
Official title: Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Social Anxiety
Keywords: social anxiety
transcranial direct current stimulation
exposure therapy
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: BAT: Matched Audience, Speech Duration
timeFrame: follow-up, one month after baseline assessment
measure: BAT: Matched Audience, Anticipated Anxiety
timeFrame: follow-up, one month after baseline assessment
measure: BAT: Matched Audience, Peak Anxiety
timeFrame: follow-up, one month after baseline assessment
measure: BAT: Unmatched Audience, Speech Duration
timeFrame: follow-up, one month after baseline assessment
measure: BAT: Unmatched Audience, Anticipated Anxiety
timeFrame: follow-up, one month after baseline assessment
measure: BAT: Unmatched Audience, Peak Anxiety
timeFrame: follow-up, one month after baseline assessment
Secondary outcomes:
measure: Personal Report of Public Speaking Anxiety
timeFrame: follow-up, one month after baseline assessment
measure: Positive Self Statements
timeFrame: follow-up, one month after baseline assessment
measure: Negative Self Statements
timeFrame: follow-up, one month after baseline assessment
Other outcomes:
Locations:
city: Reno
country: United States
facility: University of Nevada, Reno
state: Nevada
Study officials:
References:
citation: 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.