Temporal Interference for Anxiety and PTSD
This study is exploring a new, non-invasive brain stimulation method called Temporal Interference (TI) to treat anxiety and PTSD. TI uses electrical stimulation devices placed on the scalp to target specific deep brain areas without affecting the surface of the brain. Researchers want to see how TI affects brain activity, mood, and behavior in people with anxiety and stress-related conditions. To join, you must be between 18 and 65 years old, speak English fluently, and not be pregnant or breastfeeding. The study will measure changes in your anxiety levels using standard questionnaires like the Hamilton Anxiety Rating Scale (HAM-A) and the State Trait Anxiety Inventory (STAI) at different times after the intervention. The current recruitment status is unclear, and the study plans to enroll 300 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 300 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your anxiety levels will be measured at baseline, 2-5 weeks after the intervention, and 6 weeks after the intervention.
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Temporal Interference in Psychiatry (TIP): Neuromodulation Using Temporal Interference
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Negar Fani, PhD, ABPP · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Hamilton Anxiety Rating Scale (HAM-A)Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-rated assessment used to quantify the severity of anxiety symptoms. It consists of 14 items, each defined by a series of symptoms that measure both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each of the 14 items is scored on a scale of 0 (not present) to 4 (very severe). Total score ranges from 0 to 56. Higher scores indicate greater anxiety severity.
- Change in State Trait Anxiety Inventory (STAI)Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
The State-Trait Anxiety Inventory (STAI) is a 40-item self-report scale used to measure the intensity of anxiety. Each item is rated on a 4-point Likert scale (e.g., 1 = "not at all" to 4 = "very much so" or 1 = "almost never" to 4 = "almost always"). Total Score ranges from 20-80 with higher scores indicate greater levels of anxiety.
- Change in Difficulties in Emotion Regulation Scale (DERS) ScoreBaseline, 2-5 weeks post-intervention, 6 weeks post-intervention
The DERS is a 36 item instrument that measures emotional dysregulation symptoms. Responses are given on a 5-point scale where 1 = almost never and 5 = almost always. The DERS scales include 1) nonacceptance of emotional responses, 2) difficulty engaging in goal-directed behavior, 3) difficulties with impulse control, 4) limited emotional awareness, 5) limited access to emotion regulation strategies, and 6) lack of emotional clarity. Total scores range from 36 to 180 and higher scores suggest greater problems with emotion regulation.
- Change in PTSD Symptom Checklist (PCL-5) ScoreBaseline, 2-5 weeks post-intervention, 6 weeks post-intervention
The PCL-5 is a 20-item self-report measure that assess the DSM-V symptoms of PTSD. Responses are given on a scale from 0 to 4 where 0 = not at all and 4 = extremely. Total scores range from 0 to 80 where higher scores indicate increased symptoms of PTSD.