Trial · NCT06889025
Therapeutic Improvement in People With Schizophrenia Undergoing tACS/CBTp (Transcranial Alternating Current Stimulation Applied Pre-cognitive Behavioral Therapy for Psychosis) Associated to Usual Medication Regimen
NCT06889025, Not applicable, Not yet recruiting, Felicia Iftene
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Therapeutic Improvement in People With Schizophrenia Undergoing tACS/CBTp (Transcranial Alternating Current Stimulation Applied Pre-cognitive Behavioral Therapy for Psychosis) Associated to Usual Medication Regimen. Trials, record NCT06889025. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06889025
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Therapeutic Improvement in People With Schizophrenia Undergoing tACS/CBTp (Transcranial Alternating Current Stimulation Applied Pre-cognitive Behavioral Therapy for Psychosis) Associated to Usual Medication Regimen
- NCT number
- NCT06889025
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 28 participants, estimated
- Lead sponsor
- Felicia Iftene
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Interventions
- Experimental: tASC/CBTp: gamma band electric stimulation for 20 minutes at the beginning of the CBTp session, Sham Comparator
- First posted
- 2025-03-21
- Last updated
- 2025-07-24
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Stroop Color-Word Test | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
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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Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT06889025/registered