Trial · NCT07892885
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Panic Disorder Severity Scale-Self Report (PDSS-SR) Total Score at End of Treatment | Baseline and Week 10 | The Panic Disorder Severity Scale-Self Report (PDSS-SR) is a 7-item self-report measure used by participants to assess the severity of panic disorder. Each item is rated from 0 to 4 based on experiences during the previous week, yielding a total score ranging from 0 to 28. Lower total scores indicate greater improvement or alleviation of panic symptoms. |
| Secondary | Proportion of Participants with a ≥40% Reduction in PDSS-SR Total Score | Baseline and Week 10 | The proportion of participants with a ≥40% reduction in the PDSS-SR total score from baseline at 10 weeks after application of the investigational or comparator device. |
| Secondary | Proportion of Participants with a PDSS-SR Total Score ≤5 | Week 10 | Proportion of Participants with a PDSS-SR Total Score ≤5 The proportion of participants with a PDSS-SR total score ≤5 at 10 weeks after application of the investigational or comparator device. |
| Secondary | Change in Panic Disorder Severity Scale (PDSS) Total Score | Baseline and Week 10 | The PDSS consists of the same 7 items as the PDSS-SR but is administered by a clinician through a structured interview. Each item is rated from 0 to 4, yielding a total score ranging from 0 to 28. Lower total scores indicate improvement or alleviation of panic symptoms. The criteria for interpreting the total score are the same as those for the PDSS-SR. |
| Secondary | Change in State-Trait Anxiety Inventory (STAI) State Anxiety Score | Baseline and Week 10 | The State-Trait Anxiety Inventory (STAI) assesses anxiety in two dimensions: anxiety as a temporary emotional state (state anxiety, STAI-1) and anxiety as a persistent personality trait (trait anxiety, STAI-2). STAI-1 consists of 20 items, with a total score ranging from 20 to 80. Lower scores indicate improvement or alleviation of anxiety. Positively worded items (e.g., "I feel calm") are reverse-scored. |
| Secondary | Change in State-Trait Anxiety Inventory (STAI) Trait Anxiety Score | Baseline and Week 10 | The State-Trait Anxiety Inventory (STAI) assesses anxiety in two dimensions: anxiety as a temporary emotional state (state anxiety, STAI-1) and anxiety as a persistent personality trait (trait anxiety, STAI-2). STAI-2 consists of 20 items, with a total score ranging from 20 to 80. Lower scores indicate improvement or alleviation of anxiety. Positively worded items are reverse-scored. |
| Secondary | Change in Agoraphobic Cognitions Questionnaire (ACQ) Score | Baseline and Week 10 | The Agoraphobic Cognitions Questionnaire (ACQ) is a 14-item measure that assesses the frequency of catastrophic thoughts that spontaneously occur when a person feels anxious or tense. Each item is rated from 1 to 5 according to how often the thought occurs during an anxious state. Lower scores indicate a reduction in the frequency of catastrophic cognitions and improvement in cognitive symptoms. |
| Secondary | Change in Albany Panic and Phobia Questionnaire (APPQ) Score | Baseline and Week 10 | The Albany Panic and Phobia Questionnaire (APPQ) is a 27-item measure that assesses fear and avoidance related to panic- and phobia-related situations. Each item is rated from 0 to 8 according to the current level of fear and avoidance associated with the situation. The APPQ consists of three subscales: agoraphobia (14 items), social phobia (8 items), and interoceptive fear (5 items). Each subscale score is calculated by summing the corresponding item scores. Lower total and subscale scores indicate reduced fear and avoidance behavior and clinically meaningful improvement. |
| Secondary | Change in Generalized Anxiety Disorder-7 (GAD-7) Total Score | Baseline and Week 10 | The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure that assesses the severity of generalized anxiety disorder and general anxiety symptoms. Each item is rated from 0 to 3 based on experiences during the previous 2 weeks, yielding a total score ranging from 0 to 21. |
| Secondary | Change in Patient Health Questionnaire-9 (PHQ-9) Total Score | Baseline and Week 10 | The Patient Health Questionnaire-9 (PHQ-9) is a self-report measure of the severity of depressive symptoms and assesses the nine symptoms of a depressive episode based on DSM diagnostic criteria. Each item is rated from 0 to 3 based on experiences during the previous 2 weeks, yielding a total score ranging from 0 to 27. |
| Secondary | Change in EuroQol 5-Dimension Score | Baseline and Week 10 | The EuroQol 5-Dimension (EQ-5D) is a self-report measure of health-related quality of life (HRQoL) consisting of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is assessed on five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems (levels 1-5). |
| Secondary | Change in Clinical Global Impression-Severity (CGI-S) Score | Baseline and Week 10 | The Clinical Global Impression-Severity (CGI-S) is a clinician-rated scale that assesses the severity of illness. Scores are rated as follows: 0 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients. |
| Secondary | Clinical Global Impression-Improvement (CGI-I) Score | Week 10 | The Clinical Global Impression-Improvement (CGI-I) is a clinician-rated scale that assesses overall change relative to baseline. No separate baseline CGI-I assessment is performed, and the CGI-I score is assessed at Week 10. Scores are rated as follows: 0 = Not assessed; 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse. |
| Secondary | Change in Panic Disorder Severity Scale-Self Report (PDSS-SR) Total Score at End of Study | Baseline and Week 18 | The Panic Disorder Severity Scale-Self Report (PDSS-SR) is a 7-item self-report measure used by participants to assess the severity of panic disorder. Each item is rated from 0 to 4 based on experiences during the previous week, yielding a total score ranging from 0 to 28. Lower total scores indicate greater improvement or alleviation of panic symptoms. |
| Secondary | Overall Cumulative Treatment Adherence | From treatment initiation (Visit 2) through Week 10 (Visit 6) | Adherence data are continuously collected and reviewed throughout the treatment period, and overall cumulative treatment adherence is calculated at Visit 6 using data accumulated from Visit 2 through Visit 6. For participants in the Meltz group, adherence is based on the number of completed treatment stages out of 77 total assigned stages. For participants in the sham control group, adherence is based on the number of days on which at least one mood or panic diary entry is completed during the period from Visit 2 through Visit 6 |
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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