Trial · NCT06889025
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 | PANSS (Positive and Negative Symptoms of Schizophrenia Scale) | Positive and Negative Symptoms of Schizophrenia scale will be applied at: Visit 1, Screening (Week 0); Visit 4, End of intervention (Week 17); Visit 5,Follow-up 1 (Week 21); Visit 6 Follow-up 2 (Week 29). | The PANSS is a standardized clinical interview that rates the presence and severity of positive and negative symptoms and general psychopathology for people with schizophrenia within the past week. The scale consists of 30 items: seven positive, seven negative, and 16 general psychopathology symptoms. The symptom severity for each item is rated according to a 7-point scale (1 = absent; 7 = extreme) to best describe the symptom's presentation. The clinical interview takes approximately 45 minutes. The patient is rated from 1 to 7 on 30 different symptoms based on the discussion and reports of family members or primary care hospital workers. As 1 is the lowest score for each item, a patient can not score lower than 30 for the total PANSS score. Scores are often given separately for positive items, negative items, and general psychopathology. |
| Primary | NSA-16 (Negative Symptom Assessment) | Negative Symptom Assessment-16: Visit 2, Baseline (Week 1); Visit 4, End of intervention (Week 17); Visit 5, Follow-up 1 (Week 21); Visit 6 Follow-up 2 (Week 29). | The NSA-16 assesses the presence, severity, and range of negative symptoms associated with schizophrenia. For rapid clinical assessment or screening of patients for negative symptoms, the NSA-4 was developed as a simplified version, retaining only 4 of the 16 items: restricted speech quantity, reduced emotion, reduced social drive, and reduced interests. Each of the four items and the overall global negative symptoms is rated on a 1 to 6-point scale where '1' represents no reduction from normal behaviors associated with the item and '6' represents a severe reduction in or absence of the behavior, with markedly impaired functionality. With respect to overall accuracy and predictive validity, the NSA-4 is comparable to the NSA-16. |
| Primary | CFS (Cognitive Flexibility Scale) | Cognitive Flexibility Scale: Visit 2, Baseline (Week1 ); Visit 3 Mid point of intervention (Week 9); Visit 4, End of intervention (Week 17); Visit 5, Follow-up 1 (Week 21); Visit 6, Follow-up 2 (Week 29). | The CFS assesses cognitive flexibility as a factor that facilitates the individual's adaptability towards events. Cognitive flexibility refers to a person's awareness that different communication styles exist in every situation and the person's willingness and self-efficacy to use different communicative styles. The scale has 12 items pertaining to the three elements of cognitive flexibility: a person's awareness of alternative communicative styles, willingness to be communicatively flexible, and self-efficacy in being communicatively flexible. The scale utilizes a 6-point Likert-type scale for each item (with 6 as "strongly agree," 5 as "agree," 4 as "slightly agree," 3 as "slightly disagree," 2 as "disagree," and 1 as "strongly disagree"). The total score was used to calculate a global score ranging from 12 to 72, with questions 2, 9, 11, and 12 being reverse-coded. A higher score indicates higher cognitive flexibility. |
| Secondary | Heart Rate Variability (HRV) | The Heart Rate Variability will be determined at Visit 2, Week 1, before and immediately after the first intervention (tACS/CBTp); it will be determined also pre and post the 16th intervention, Visit 4, Week 17. | Heart Rate Variability (HRV) refers to the variation in time between consecutive heartbeats, a normal physiological phenomenon indicating the body's ability to adapt to stress and demands. There is no single "ideal" HRV, a higher HRV generally indicates better cardiovascular health and fitness, with a normal range other considered to be between 40 and 100 milliseconds. However, individual HRV levels vary based o age, fitness level, and other factors and tracking baseline HRV and trends for an individual, is more important than comparing to others. |
| Secondary | Electroencephalogram (EEG) | Electroencephalogram will be performed at the Visit 1, Screening (Week 0) and Visit 5 End of intervention (Week 17) - before and at the end of intervention (the 16 tAC/CBTp sessions) | Electroencephalogram detects abnormalities in brain waves, or in the electrical activity of the brain. The electrical charges resulting from the activity of the the brain cells, are collected by scalp electrodes, amplified and recorded as a graph on a computer, or printed out on a paper. Our previous EEG recordings showed reduced power and synchronization on gamma oscillations, that in healthy people are 30-100HZ, but in people with schizophrenia gamma activity is narrowly defined as 37-41 Hz. Gamma oscillations specifically controls the connectivity between different specific brain regions, which is crucial for perception, movement, memory and emotions. We are performing resting state EEG (no stimulation, no tasks) an we will analyze the EEG brain oscillation activity, targeting the possible changes of the gamma band activity in the prefrontal cortex (we are looking at the tendency to organize the neural oscillations in the gamma frequency range, mainly in frontal lobes). |
| Secondary | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | The WHODAS 2.0 will be performed at: Visit 2, Baseline (Week 1), Visit 4, End of intervention (Week 17), Visit 5, Follow-up 1 (Week 21), Visit 6, Follow-up 2 (Week 29). | The WHODAS 2.0 measures the level of functioning in six domains of life: cognition - understanding and communicating; mobility - moving and getting around; self-care - attending to one's hygiene, dressing, eating and staying alone; getting along - interacting with other people; life activities - domestic responsibilities, leisure, work and school; participation - joining in community activities, participating in society. The 36-item version of WHODAS 2.0 is the most detailed (questions about the difficulties experienced in the past 30 days). It allows users to generate scores for the six functioning domains and calculate an overall functioning score. The average interview time for the interviewer-administered 36-item version is 20 minutes. The simple sum of the scores of the items across all domains constitutes a statistic that describes the degree of functional limitations. The scores are ranging from o to 100, where higher scores indicate greater disability |
| Secondary | The Quality-of-Life Enjoyment and Satisfaction Questionnaire Short Form (Q-Les-Q-SF) | The Q-Les-Q-SF will be performed at: Visit 2, Baseline (Week 1); Visit 3 Mid-way intervention (Week 9), Visit 4 End of intervention (Week 17); Visit 5 Follow-up 1 (Week 21); Visit 6 Follow-up 2 (Week 2.9) | The Q-Les-Q-SF is a 16-item, participant-scored survey utilized to quantify changes in quality of life. The Q-LES-Q-SF evaluates general activities that are assessed in the longer form: physical health, feelings, work, household duties, school/course work, leisure time activities, and social relations. Participants rate their satisfaction using a 5-point scale ranging from 1 (very poor) to 5 (very good). A total score is derived from 14 items, with a maximum score of 70, higher scores indicating greater life satisfaction and enjoyment. |
| Secondary | Brief Betrayal Trauma Survey (BBTS) | Brief Betrayal Trauma Survey will be performed at Visit 2, Baseline. | The Brief Betrayal Trauma Survey - BBTS is a semi structured interview, that measures 14 potentially traumatic events involving mistreatment by someone close, not so close, and non-interpersonal events. Respondents indicate how frequently they experienced an event before and after age 18. Scoring: categorizing of items into High, Medium and Low Betrayal. |
| Secondary | Perceived Stress Scale (PCP) | Perceived Stress Scale (PCP) will be performed at: Visit 2, Baseline (Week 1), Visit 4, End of intervention (Week 17), Visit 5, Follow-up 1 (Week 21), Visit 6, Follow-up 2 (Week 29). | The Perceived Stress Scale (PCP) is one of the most widely used psychological instruments for measuring stress perception. It measures the degree to which situations in one's life are perceived as stressful. The 10 items inquire on how unpredictable, uncontrollable, and overloaded respondents find their lives as well as current levels of experienced stress. The questions in the PSS ask about feelings and thoughts concerning experiences during the last month. In each item, respondents are asked how often they felt a certain way. Individual scores on the PSS can range from 0 to 40, with higher scores indicating higher perceived stress. |
| Secondary | The Personal Evaluation of Transitions in Treatment (PETiT). | The Personal Evaluation of Transitions in Treatment (PETiT) will be performed at: Visit 2, Baseline (Week 1), Visit 4, End of intervention (Week 17), Visit 5, Follow-up 1 (Week 21), Visit 6, Follow-up 2 (Week 29). | The PETiT is a self-administered scale, user-friendly and sensitive to changes associated with treatment over time. Consisting of 30 items, it considers the respondent's health in the last week and offers one of three responses ('often,' 'sometimes,' or 'never'). The scale assesses two highly relevant domains for schizophrenia: adherence-related attitude (includes six items reflecting adherence and feelings towards medication) and psychosocial functioning (24 items describing patient characteristics such as clarity, energy, concentration, functioning, sex drive and memory). The PETiT total score ranges from 0 to 60, with higher scores indicating better patient health-related quality of life. |
| Secondary | The Working Alliance Inventory - Short Revised (WAI-SR) - both forms: for client and therapist. | The Working Alliance will be tested at Visit 3, Mid-term through intervention (Week 9) and Visit 4, End of intervention (Week 17). | The WAI-SR measures three critical aspects of the therapeutic alliance: agreement on the tasks of therapy, agreement on the goals of therapy and development of an affective bond. The 12 items are rated on a 5-point Likert scale ranging from 1 = 'never' to 5 = 'always.' The scores range from 5 to 20, with higher scores indicating a better therapeutic alliance. Completing the WAI-SR takes about 5 minutes. |
| Secondary | The BEM Sex Role Inventory (BSRI) | The BEM Sex Role Inventory (BSRI) is performed at Visit 1, Screening (Week 0) | The BEM Sex Role Inventory (BSRI) is a psychological tool used to measure an individual's perception of their own masculinity and feminity, and it is used to research gender roles, with the understanding that individuals can express both masculine and feminine traits. The interview has 12 items, with scores on a 1 (never or almost never true) -7 (always or always true) scale with average calculated for masculine and feminine traits, and then categorizes them as masculine, feminine, androgynous, or undifferentiated based on those scores. Each item is assigned a category as follows: M for masculine, F for Feminine, N for Neutral. |
| Secondary | The STROOP Color and Word Test | The STROOP Color and Word Test will be applied at Visit 2, Baseline (Week 0) and at Visit 4, End of intervention (Week 17). | The STROOP Color and Word Test, developed by John Ridley Stroop, is a neuropsychological test that measures cognitive interference by asking participants to name the ink color of words, which are printed in a color that conflicts with the word itself. The STROOP scores are based on 3 factors: color-naming, interference, and speed, converted into T score for interpretation. A T-score of 40 or less in considered low, while above 40 is considered normal. |
| Other | Eligibility Screening Measures: Columbia Suicide Severity Rating Scale | At Screening, Visit 1(Week 0). | The Columbia Suicide Severity Rating Scale - C-SSRS is a questionnaire developed by multiple institutions, including Columbia University, to help establish a person's immediate risk of suicide. Its questions are phrased for use in an interview format but can be completed as a self-report measure if necessary. The C-SSRS measures four constructs: the severity of ideation, the intensity of ideation, behavior and lethality. It includes "stem questions," which, if endorsed, prompt additional follow-up questions to obtain more information. The C-SSRS comprises ten categories, all of which maintain binary responses (yes/no) to indicate the presence or absence of the behavior. The outcome of the C-SSRS is a numerical score with no specified clinical cut-offs due to the binary nature of the responses to items. Ultimately, interpretation is derived from a thorough clinical assessment, client history, and clinical expertise. |
| Other | Eligibility Screening Measures: The Montreal Cognition Assessment (MoCA), for participants over age of 65. | The Montreal Cognition Assessment MoCA will be performed at Visit 1, Screening (Week 0), to participants over age of 65 (to exclude a possible cognitive decline). | The The Montreal Cognition Assessment MoCA is a popular tool used in clinical practice when assessing for mild cognitive dysfunction. This instrument evaluates various cognitive domains, including attention, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. Administering the MoCA takes around 10 minutes, and the total possible score is 30 points. A score of 26 or higher is considered normal, while a final score below 26 suggests mild cognitive impairment. |
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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