Trial · NCT07909200
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 1 | Baseline and Week 1 | Anxiety severity will be evaluated using the Hamilton Anxiety Rating Scale (HAMA), a clinician-administered instrument comprising 14 items. Total scores range from 0 to 56, with higher scores indicating more severe anxiety symptoms. The outcome is the change in HAMA total score from baseline to Week 1. |
| Secondary | Clinical Response Rate | Week 1, Week 4, and Week 8 | Clinical response will be assessed using the Hamilton Anxiety Rating Scale (HAMA), a 14-item clinician-administered scale with a total score range of 0 to 56. Higher scores indicate greater anxiety symptom severity, which represents a worse outcome. Clinical response is defined as a reduction of at least 50% in HAMA total score compared with baseline. |
| Secondary | Clinical Remission Rate | Week 1, Week 4, and Week 8 | Clinical remission will be assessed using the Hamilton Anxiety Rating Scale (HAMA), a 14-item clinician-administered scale with a total score range of 0 to 56. Higher scores indicate greater anxiety symptom severity, which represents a worse outcome. Clinical remission is defined as a HAMA total score of 7 or less at the corresponding assessment time point. |
| Secondary | Change in Hamilton Anxiety Rating Scale (HAMA) Total Score | Baseline, Week 1, Week 4, and Week 8 | Anxiety severity will be evaluated using the Hamilton Anxiety Rating Scale (HAMA), a clinician-administered instrument comprising 14 items. Total scores range from 0 to 56, with higher scores indicating more severe anxiety symptoms. The outcome is the change in HAMA total score from baseline to each subsequent assessment time point. |
| Secondary | Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score | Baseline, Week 1, Week 4, and Week 8 | Depressive symptom severity will be assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17), a clinician-administered scale with a total score range of 0 to 52. Higher scores indicate greater depressive symptom severity, which represents a worse outcome. The outcome will be calculated as the change in HAMD-17 total score from baseline to each post-baseline assessment time point. |
| Secondary | Change in Generalized Anxiety Disorder-7 (GAD-7) Score | Baseline, Week 1, Week 4, and Week 8 | Anxiety symptom severity will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report questionnaire with a total score range of 0 to 21. Higher scores indicate greater anxiety symptom severity, which represents a worse outcome. The outcome will be calculated as the change in GAD-7 score from baseline to each post-baseline assessment time point. |
| Secondary | Change in Intolerance of Uncertainty Scale (IUS) Score | Baseline, Week 1, Week 4, and Week 8 | Intolerance of uncertainty will be assessed using the Intolerance of Uncertainty Scale (IUS), a 27-item self-report questionnaire with a total score range of 27 to 135. Higher scores indicate greater intolerance of uncertainty, which represents a worse outcome. The outcome will be calculated as the change in IUS total score from baseline to each post-baseline assessment time point. |
| Secondary | Change in Anxiety and Depression Visual Analogue Scale Scores | Baseline, Day 1, Week 1, Week 4, and Week 8 | Subjective anxiety and depression severity will be assessed using visual analogue scale ratings for anxiety and depression. Each visual analogue scale score ranges from 0 to 10, with higher scores indicating greater subjective symptom severity, which represents a worse outcome. The outcome will be calculated as the change in visual analogue scale scores from baseline to each post-baseline assessment time point |
| Secondary | Treatment-Emergent Side Effects During the Intervention and Follow-up Period | Week 1, Week 4, and Week 8 | Treatment-emergent side effects will be assessed using a physical treatment side-effect assessment that records the presence, type, severity, and relationship to the study intervention of adverse events. This outcome will be summarized as the occurrence and severity of treatment-emergent side effects during the intervention and follow-up period; higher severity indicates a worse safety outcome. |
| Other | Change in EEG Theta-Band Power | Baseline, Week 1, and Week 8 | Brain electrophysiological activity will be assessed using electroencephalography (EEG). Theta-band power (4-8 Hz) will be assessed using EEG. The outcome will be calculated as the change in theta-band power from baseline to each post-baseline assessment. |
| Other | Change in Right Amygdala Seed-Based Resting-State Functional Connectivity | Baseline, Week 1, and Week 8 | Resting-state functional magnetic resonance imaging (fMRI) will be used to assess functional connectivity between the right amygdala and other brain regions. Connectivity will be quantified using Fisher z-transformed Pearson correlation coefficients between regional blood oxygen level-dependent (BOLD) signal time series. Changes from baseline will be calculated at each post-baseline MRI assessment. |
| Other | Change in Right BNST Seed-Based Resting-State Functional Connectivity | Baseline, Week 1, and Week 8 | Resting-state functional magnetic resonance imaging (fMRI) will be used to assess functional connectivity between the right bed nucleus of the stria terminalis (BNST) and other brain regions. Connectivity will be quantified using Fisher z-transformed Pearson correlation coefficients between regional blood oxygen level-dependent (BOLD) signal time series. Changes from baseline will be calculated at each post-baseline MRI assessment. |
| Other | Blinding Integrity at the End of Treatment | Week 1 | Blinding integrity will be assessed using a brief questionnaire completed independently by participants and outcome assessors after the week 1 primary outcome assessment. Respondents will indicate whether they believe the participant received active stimulation, sham stimulation, or "do not know." They will also be asked to guess the specific treatment assignment: right BNST-targeted stimulation, right amygdala-targeted stimulation, sham stimulation, or "do not know." The reasons for their guesses will be recorded. The percentages of correct guesses, incorrect guesses, and "do not know" responses will be summarized by randomized group, separately for participants and outcome assessors. Actual treatment assignments will not be disclosed during this assessment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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