- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07935005
Efficacy and Neural Mechanisms of Individualized Neuromodulation Combined With Think/No-Think Training in Individuals With Internalizing Disorders (INTS)
Efficacy and Neural Mechanisms of Individualized Neuromodulation Combined With Thought Suppression Training in Individuals With Internalizing Disorders
This study aims to investigate the therapeutic efficacy and neural mechanisms of individualized neuromodulation combined with autobiographical Think/No-Think (TNT) thought suppression training in individuals with internalizing disorders, including anxiety disorders, depressive disorders, obsessive-compulsive disorder (OCD), and post-traumatic stress disorder (PTSD), including complex PTSD (cPTSD).
Internalizing disorders share common clinical features, including excessive negative emotional processing, impaired regulation of intrusive thoughts and memories, and difficulties in cognitive control. Increasing evidence suggests that impaired thought suppression is a transdiagnostic mechanism contributing to persistent negative thoughts, intrusive memories, rumination, and emotional dysregulation across different psychiatric conditions. However, effective interventions targeting this shared cognitive mechanism remain limited.
This study is designed to examine whether individualized neuromodulation targeting abnormal neural circuits and oscillatory activity can enhance thought suppression ability and improve clinical symptoms. The study is based on the hypothesis that dysfunction of prefrontal-limbic and memory-related networks, including altered interactions between prefrontal cortex, hippocampal, and amygdala-related circuits, contributes to impaired cognitive control over unwanted thoughts and memories. Furthermore, individual differences in neural oscillatory characteristics may provide biomarkers for optimizing neuromodulation parameters.
Eligible participants with internalizing disorders will undergo comprehensive clinical assessments, behavioral assessments, electroencephalography (EEG), and magnetic resonance imaging (MRI) evaluations before intervention. Behavioral assessment will include an autobiographical Think/No-Think (TNT) paradigm designed to measure participants' ability to intentionally regulate retrieval of unwanted autobiographical memories. EEG and MRI assessments will be used to characterize individual neural oscillatory features and functional brain network characteristics associated with cognitive control, emotional regulation, and memory processing.
Participants will be randomly assigned to one of five parallel intervention groups according to the study protocol:
Individualized temporal interference stimulation (TIS) combined with autobiographical TNT thought suppression training; Individualized beta-frequency transcranial alternating current stimulation (tACS) combined with autobiographical TNT thought suppression training; Sham neuromodulation combined with autobiographical TNT thought suppression training; Individualized beta-frequency tACS alone; Individualized TIS alone.
The first neuromodulation approach, individualized tACS, targets the right anterior dorsolateral prefrontal cortex (aDLPFC), a key region involved in cognitive control and thought suppression. The stimulation frequency will be individualized according to each participant's resting-state EEG beta-band peak characteristics.
The second neuromodulation approach, individualized TIS, aims to modulate deep brain networks involved in emotional memory regulation and cognitive control. TIS stimulation parameters will be individualized according to participant-specific neurophysiological characteristics, with a focus on theta-related neural activity associated with limbic and memory-related circuits.
During the combined intervention conditions, individualized tACS or TIS will be administered concurrently with autobiographical TNT training. Participants will practice intentionally retrieving autobiographical memories during Think trials and suppressing retrieval of unwanted autobiographical memories during No-Think trials. The tACS-only and TIS-only groups will receive the corresponding individualized neuromodulation intervention without TNT training, allowing evaluation of the independent effects of neuromodulation and comparison with combined neuromodulation-cognitive training approaches. Sham stimulation combined with TNT training will serve as a control condition for evaluating the specific contribution of active neuromodulation.
The intervention period will last six days according to the study protocol. Clinical symptoms, thought suppression ability, emotional regulation, and behavioral performance will be assessed before and after intervention. Additional clinical follow-up assessments will be conducted at one month and six months after intervention to evaluate the durability of treatment effects.EEG and MRI assessments will be performed before and after intervention to investigate neurophysiological and neural network changes associated with treatment response.
연구 개요
상태
상세 설명
This study is a randomized controlled clinical trial investigating the therapeutic effects and neural mechanisms of individualized neuromodulation combined with autobiographical Think/No-Think (TNT) thought suppression training in individuals with internalizing disorders, including anxiety disorders, depressive disorders, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and complex PTSD (cPTSD).
A total of 150 participants with internalizing disorders will be recruited and randomly assigned into five parallel intervention groups. The intervention period consists of six consecutive treatment days, with one session administered daily. Each session lasts approximately one hour and includes the assigned neuromodulation procedure and/or autobiographical TNT thought suppression training according to the assigned condition.
The study investigates whether individualized neuromodulation targeting neural systems involved in cognitive control and memory regulation can enhance the ability to suppress unwanted thoughts and memories and improve clinical symptoms. The study also examines whether combining neuromodulation with targeted thought suppression training produces additional effects compared with neuromodulation alone or behavioral training with sham stimulation.
Autobiographical Think/No-Think Training
The behavioral intervention is based on an autobiographical TNT paradigm adapted for individuals with internalizing disorders. Before intervention, participants will identify personally relevant negative memories, intrusive thoughts, worries, or symptom-related mental contents under the guidance of trained researchers. For participants with trauma-related symptoms, selected materials will be related to their individual traumatic experiences or trauma-associated memories while following appropriate ethical and safety procedures.
Each selected memory or thought will be paired with a neutral cue word to create individualized cue-target associations. The selected materials will be evaluated according to subjective characteristics, including emotional intensity, vividness, distress level, and personal relevance.
During Think trials, participants will be instructed to intentionally retrieve and elaborate the associated autobiographical memory or thought when the cue appears. During No-Think trials, participants will be instructed to actively prevent the associated unwanted memory or thought from entering conscious awareness. Participants will be specifically instructed not to replace the unwanted thought with another deliberate thought or distraction strategy, but instead to practice intentional suppression of the original mental content.
Repeated TNT training sessions will be conducted throughout the intervention period. Behavioral performance, including memory accessibility, subjective emotional responses, and suppression-related changes, will be evaluated before and after training.
Individualized Neuromodulation Intervention
Participants will receive one of five intervention conditions according to randomized assignment.
The individualized tACS intervention targets the right anterior dorsolateral prefrontal cortex (aDLPFC), a region involved in executive control and intentional regulation of internally generated information. The stimulation frequency will be determined based on each participant's individual beta-band characteristics derived from resting-state EEG analysis.
The individualized TIS intervention targets deep neural networks involved in memory retrieval and emotional regulation, with a focus on hippocampal-related neural systems. Individual stimulation parameters will be determined according to participant-specific neurophysiological characteristics, including individualized theta-band features obtained from multimodal assessment.
In combined intervention conditions, neuromodulation will be delivered during autobiographical TNT training to investigate whether modulation of cognitive-control or memory-related neural systems can enhance thought suppression training effects.
The tACS-only and TIS-only groups will receive the corresponding individualized neuromodulation intervention without TNT training, allowing examination of the independent effects of neuromodulation. The sham stimulation combined with TNT group will receive identical TNT training procedures with sham stimulation to control for behavioral training effects, expectancy effects, and nonspecific stimulation-related effects.
Clinical and Behavioral Assessments
Clinical assessments will be conducted before and after the intervention, with follow-up evaluations performed after treatment to examine the persistence of intervention-related changes.
The assessment battery includes measures of anxiety symptoms, depressive symptoms, sleep quality, worry, rumination, thought suppression ability, intrusive thoughts, obsessive-compulsive symptoms, and trauma-related symptoms.
Clinical measures include:
Hamilton Anxiety Rating Scale (HAMA) for anxiety symptoms; Hamilton Depression Rating Scale (HAMD) for depressive symptoms; Pittsburgh Sleep Quality Index (PSQI) for sleep quality; Penn State Worry Questionnaire (PSWQ) for pathological worry; Ruminative Response Scale (RRS) for rumination tendency; Thought Control Ability Questionnaire (TCAQ) for perceived ability to control thoughts; White Bear Suppression Inventory (WBSI) for habitual thought suppression tendency; Perseverative Thinking Questionnaire (PTQ) for repetitive negative thinking; Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and Obsessive-Compulsive Inventory-Revised (OCI-R) for obsessive-compulsive symptoms; PTSD-related clinical assessments for trauma-related symptoms when applicable.
Behavioral assessments include autobiographical TNT performance measures, including suppression-related memory accessibility, subjective distress, emotional intensity, and changes in control over unwanted mental content.
EEG and MRI Assessment
Resting-state EEG and resting-state functional MRI (rs-fMRI) assessments will be conducted before and after intervention to investigate neurophysiological and functional network changes associated with treatment.
Resting-state EEG will be used to characterize individual neural oscillatory features, including theta- and beta-band activity. EEG analyses will examine changes in oscillatory power, frequency characteristics, and functional connectivity related to cognitive control and thought suppression.
Resting-state MRI will be used to examine functional connectivity changes within neural networks associated with executive control, memory retrieval, and emotional regulation. Particular attention will be given to interactions among prefrontal regions and hippocampal-related networks.
Multimodal analyses integrating EEG, MRI, behavioral performance, and clinical measures will be conducted to investigate neural mechanisms associated with intervention response.
Data Analysis
Clinical and behavioral outcomes will be analyzed using repeated-measures statistical models to examine changes from baseline to post-intervention and follow-up assessments. Between-group comparisons will evaluate differences among the five intervention conditions.
Associations between changes in clinical symptoms, TNT performance, EEG characteristics, and MRI-based functional connectivity will be examined to identify neural correlates of treatment response.
EEG analyses will evaluate intervention-related changes in oscillatory activity, including individualized beta and theta characteristics, resting-state spectral features, and functional connectivity measures.
MRI analyses will examine changes in resting-state functional connectivity within cognitive-control and memory-related networks. Multimodal statistical approaches will be used to explore relationships among baseline neural characteristics, stimulation parameters, neural changes, and clinical outcomes.
Multiple comparison correction procedures will be applied where appropriate, and effect sizes and confidence intervals will be reported.
This study aims to investigate whether individualized neuromodulation combined with autobiographical thought suppression training can modify neural systems involved in cognitive control and memory regulation and improve symptoms associated with internalizing disorders.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: chunyan zhu, PhD
- 전화번호: +86 13865998867
- 이메일: ayswallow@126.com
연구 연락처 백업
- 이름: yian xiao, master
- 전화번호: +86 13155657579
- 이메일: x1248449932@gmail.com
연구 장소
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Anhui
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Hefei, Anhui, 중국, 230032
- The Fourth People's Hospital of Hefei, Hefei, AnHui, China
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연락하다:
- anzhen wang
- 전화번호: +86 13956090060
- 이메일: 1332954537@qq.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults aged 18-50 years.
- Participants who meet diagnostic criteria for one or more internalizing disorders, including anxiety disorders, depressive disorders, obsessive-compulsive disorder (OCD), or post-traumatic stress disorder (PTSD), according to standardized diagnostic assessment.
- Participants are recruited primarily from outpatient psychiatric services and have a relatively stable clinical condition suitable for participation in a neuromodulation intervention study.
- Participants are able to understand the study procedures and provide written informed consent.
- Participants are able to complete clinical assessments, behavioral tasks, electroencephalography (EEG), magnetic resonance imaging (MRI), and neuromodulation procedures required by the study protocol.
- Participants have sufficient cognitive ability and communication skills to complete the autobiographical Think/No-Think (TNT) thought suppression training.
Exclusion Criteria:
- Current or lifetime diagnosis of schizophrenia spectrum disorders or bipolar disorders.
- Current severe suicidal ideation, recent suicidal behavior, or clinically significant suicide risk requiring urgent intervention.
- Severe aggressive behavior, marked impulsivity, or behavioral instability that may interfere with study participation or safety assessment.
- Neurological disorders, including epilepsy, history of seizures, significant head injury, brain tumors, or other neurological conditions that may affect EEG, MRI, or cognitive functioning.
- Abnormal EEG findings indicating clinically significant epileptiform activity or other abnormalities requiring medical evaluation.
- Contraindications to MRI examination, including implanted metal devices, ferromagnetic foreign bodies, incompatible medical implants, or other conditions preventing safe MRI scanning.
- Severe medical conditions or unstable physical illness that may influence participation or study outcomes.
- Current substance dependence or severe substance use problems.
- Current use of medications or undergoing treatments that are considered unsuitable according to the study protocol.
- Pregnancy or other conditions that may increase risks associated with neuromodulation or MRI procedures.
- Participants who experience significant discomfort, intolerance, or adverse reactions during neuromodulation procedures and cannot safely continue the intervention.
- Any other condition judged by the investigators to affect study safety, compliance, or interpretation of results.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Individualized TIS Combined With Thought Suppression Training
Participants in this arm will receive individualized temporal interference stimulation (TIS) combined with autobiographical Think/No-Think (TNT) thought suppression training. Approximately 30 outpatients aged 18-50 years with internalizing disorders will be enrolled, including patients with anxiety disorders, depressive disorders, comorbid anxiety and depressive disorders, obsessive-compulsive disorder, or post-traumatic stress disorder. Participants with schizophrenia spectrum disorders, bipolar disorders, current suicidal behavior, or high aggression/impulsive risk will not be included. TIS parameters will be individualized based on participant-specific neurophysiological characteristics. During the intervention period, TIS will be administered concurrently with autobiographical TNT training to investigate whether modulation of deep emotional-memory related neural circuits enhances thought suppression ability and emotional regulation. |
Individualized temporal interference stimulation (TIS) will be used to non-invasively modulate deep brain networks involved in emotional processing and cognitive control. The stimulation target will be determined based on participant-specific neuroimaging and neurophysiological characteristics. Stimulation parameters, including frequency configuration, will be individualized according to the study protocol. In the combined intervention arm, TIS will be administered concurrently with autobiographical Think/No-Think thought suppression training to examine whether modulation of deep emotional-memory related circuits improves thought suppression ability and emotional regulation. Autobiographical Think/No-Think (TNT) training is a behavioral intervention designed to enhance the ability to regulate unwanted thoughts and memories. Participants will generate personally relevant autobiographical events and learn cue-event associations before training. During Think trials, participants will intentionally retrieve the associated event, whereas during No-Think trials, participants will practice suppressing retrieval of the associated event when presented with the cue. The training is designed to improve cognitive control over unwanted mental content and will be administered according to the study protocol. |
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실험적: Individualized tACS Combined With Thought Suppression Training
Participants in this arm will receive individualized transcranial alternating current stimulation (tACS) combined with autobiographical Think/No-Think (TNT) thought suppression training. Approximately 30 outpatients aged 18-50 years with internalizing disorders will be enrolled, including anxiety disorders, depressive disorders, comorbid anxiety and depressive disorders, obsessive-compulsive disorder, or post-traumatic stress disorder. Participants with schizophrenia spectrum disorders, bipolar disorders, current suicidal behavior, or high aggression/impulsivity risk will be excluded. tACS stimulation parameters will be individualized according to participant-specific EEG characteristics, with targeting of cortical regions involved in cognitive control. tACS will be delivered during TNT training to examine whether enhancing prefrontal neural regulation improves suppression of unwanted thoughts and emotional regulation. |
Autobiographical Think/No-Think (TNT) training is a behavioral intervention designed to enhance the ability to regulate unwanted thoughts and memories. Participants will generate personally relevant autobiographical events and learn cue-event associations before training. During Think trials, participants will intentionally retrieve the associated event, whereas during No-Think trials, participants will practice suppressing retrieval of the associated event when presented with the cue. The training is designed to improve cognitive control over unwanted mental content and will be administered according to the study protocol. Individualized transcranial alternating current stimulation (tACS) targeting the right anterior dorsolateral prefrontal cortex (aDLPFC) will be administered to modulate cortical oscillatory activity associated with cognitive control and thought suppression. Stimulation frequency will be individualized according to each participant's resting-state EEG beta-band peak. tACS will be delivered according to the study protocol, including predefined stimulation intensity, duration, and session schedule. In the combined intervention arm, tACS will be administered concurrently with autobiographical Think/No-Think thought suppression training to investigate whether individualized modulation of prefrontal neural oscillations enhances cognitive control and emotional regulation. |
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가짜 비교기: Sham Neuromodulation Combined With Thought Suppression Training
Participants in this arm will receive sham neuromodulation combined with autobiographical Think/No-Think (TNT) thought suppression training. Approximately 30 outpatients aged 18-50 years with internalizing disorders will be enrolled, including anxiety disorders, depressive disorders, comorbid anxiety and depressive disorders, obsessive-compulsive disorder, or post-traumatic stress disorder. Participants with schizophrenia spectrum disorders, bipolar disorders, current suicidal behavior, or high aggression/impulsivity risk will not be included. Sham stimulation procedures will mimic the sensory experience and experimental procedures of active stimulation without delivering the active neuromodulatory intervention. Participants will complete the same TNT training protocol as active stimulation groups, allowing evaluation of the additional effects of individualized neuromodulation beyond behavioral thought suppression training. |
Autobiographical Think/No-Think (TNT) training is a behavioral intervention designed to enhance the ability to regulate unwanted thoughts and memories. Participants will generate personally relevant autobiographical events and learn cue-event associations before training. During Think trials, participants will intentionally retrieve the associated event, whereas during No-Think trials, participants will practice suppressing retrieval of the associated event when presented with the cue. The training is designed to improve cognitive control over unwanted mental content and will be administered according to the study protocol. Sham neuromodulation will be used as a control condition to evaluate the specific effects of active stimulation. The procedure will use the same electrode placement and initial stimulation procedures as active neuromodulation conditions but will not deliver sustained active stimulation. Participants will undergo the same study procedures and, where applicable, the same autobiographical Think/No-Think thought suppression training as active intervention groups. |
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실험적: Individualized tACS Alone
Participants in this arm will receive individualized transcranial alternating current stimulation (tACS) without concurrent Think/No-Think (TNT) thought suppression training. Approximately 30 outpatients aged 18-50 years with internalizing disorders will be enrolled, including anxiety disorders, depressive disorders, comorbid anxiety and depressive disorders, obsessive-compulsive disorder, or post-traumatic stress disorder. Participants with schizophrenia spectrum disorders, bipolar disorders, current suicidal behavior, or high aggression/impulsivity risk will not be included. Individualized tACS parameters will be determined according to participant-specific EEG characteristics and applied to modulate neural oscillatory activity associated with cognitive control and emotional regulation. This arm is designed to evaluate the effects of neuromodulation alone on clinical symptoms and neural mechanisms without simultaneous cognitive training. |
Individualized transcranial alternating current stimulation (tACS) targeting the right anterior dorsolateral prefrontal cortex (aDLPFC) will be administered to modulate cortical oscillatory activity associated with cognitive control and thought suppression. Stimulation frequency will be individualized according to each participant's resting-state EEG beta-band peak. tACS will be delivered according to the study protocol, including predefined stimulation intensity, duration, and session schedule. In the combined intervention arm, tACS will be administered concurrently with autobiographical Think/No-Think thought suppression training to investigate whether individualized modulation of prefrontal neural oscillations enhances cognitive control and emotional regulation. |
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실험적: Individualized TIS Alone
Participants in this arm will receive individualized temporal interference stimulation (TIS) without concurrent Think/No-Think (TNT) thought suppression training. Approximately 30 outpatients aged 18-50 years with internalizing disorders will be enrolled, including anxiety disorders, depressive disorders, comorbid anxiety and depressive disorders, obsessive-compulsive disorder, or post-traumatic stress disorder. Participants with schizophrenia spectrum disorders, bipolar disorders, current suicidal behavior, or high aggression/impulsivity risk will not be included. TIS stimulation parameters will be individualized based on participant-specific neurophysiological characteristics and used to modulate deep brain networks associated with emotional processing and cognitive control. This arm is designed to examine the independent effects of individualized deep-brain neuromodulation on clinical symptoms and neural mechanisms. |
Individualized temporal interference stimulation (TIS) will be used to non-invasively modulate deep brain networks involved in emotional processing and cognitive control. The stimulation target will be determined based on participant-specific neuroimaging and neurophysiological characteristics. Stimulation parameters, including frequency configuration, will be individualized according to the study protocol. In the combined intervention arm, TIS will be administered concurrently with autobiographical Think/No-Think thought suppression training to examine whether modulation of deep emotional-memory related circuits improves thought suppression ability and emotional regulation. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Thought Suppression Ability
기간: Baseline, immediately after the 6-day intervention, 1-month follow-up, and 6-month follow-up
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Thought control ability will be assessed using the 25-item Thought Control Ability Questionnaire (TCAQ). Each item is rated on a 5-point Likert scale(1-5), and the total score ranges from 25 to 125. Higher scores indicate greater perceived ability to control unwanted thoughts and represent a better outcome. The outcome measure will be the change in total TCAQ score from baseline to immediately post-intervention and from baseline to the 1-month and 6-month follow-ups. |
Baseline, immediately after the 6-day intervention, 1-month follow-up, and 6-month follow-up
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Change in Emotional Responses to Personally Relevant Events
기간: Baseline, immediately after the 6-day intervention, 1-month follow-up, and 6-month follow-up
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Participants will rate personally relevant autobiographical events at baseline and immediately post-intervention on seven dimensions, each dimension will be rated independently on a 5-point Likert scale (1-5), with no composite or total score calculated.Higher scores generally indicate stronger subjective representations and emotional responses to the events: Vividness: Vividness of the mental representation. Perceived likelihood: Perceived likelihood of occurrence within the next 2 years. Event-related anxiety or joy: Anxiety associated with negative events or joy associated with positive events. Frequency of thoughts: Frequency of thinking about the event. Current concern: Degree of current concern about the event. Perceived long-term impact: Anticipated duration or extent of long-term impact. Emotional intensity: Intensity of the emotional response. Changes in each dimension will be calculated from baseline to post-intervention. |
Baseline, immediately after the 6-day intervention, 1-month follow-up, and 6-month follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Anxiety Symptoms
기간: Baseline, immediately after the 6-day intervention, 1-month follow-up, and 6-month follow-up
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Anxiety symptoms will be assessed using the 14-item Hamilton Anxiety Rating Scale (HAMA), a clinician-administered scale. The total score ranges from 0 to 56, with higher scores indicating greater anxiety symptom severity (worse outcome). The outcome will be the change in total HAMA score from baseline to each post-intervention and follow-up assessment. |
Baseline, immediately after the 6-day intervention, 1-month follow-up, and 6-month follow-up
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Change in Depressive Symptoms
기간: Baseline, immediately after the 6-day intervention, 1-month follow-up, and 6-month follow-up
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Depressive symptoms will be assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17). The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity (worse outcome). The outcome will be the change in total HAMD-17 score from baseline to each post-intervention and follow-up assessment. |
Baseline, immediately after the 6-day intervention, 1-month follow-up, and 6-month follow-up
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Change in Sleep Quality
기간: Baseline, immediately after the six-day intervention, 1-month follow-up, and 6-month follow-up.
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Sleep quality will be assessed using the 19-item Pittsburgh Sleep Quality Index (PSQI), referring to the previous month. Seven components are scored from 0 to 3: (1) subjective sleep quality (item 6); (2) sleep latency (items 2 and 5a, combined); (3) sleep duration (item 4); (4) habitual sleep efficiency (calculated from items 1, 3, and 4); (5) sleep disturbances (items 5b-5j, combined); (6) use of sleeping medication (item 7); and (7) daytime dysfunction (items 8 and 9, combined). Raw responses are converted into component scores using the standard PSQI scoring algorithm. The seven component scores are summed to yield a global score of 0-21. Higher scores indicate poorer sleep quality. The outcome is the change in global score from baseline to each post-intervention and follow-up assessment. |
Baseline, immediately after the six-day intervention, 1-month follow-up, and 6-month follow-up.
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Change in Pathological Worry
기간: Baseline, immediately after the 6-day intervention, and 1-month follow-up
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Pathological worry will be assessed using the 16-item Penn State Worry Questionnaire (PSWQ). Each item is rated on a 5-point Likert scale (1-5), yielding a total score of 16-80. Higher scores indicate greater pathological worry (worse outcome). The outcome will be the change in total PSWQ score from baseline to each post-intervention and follow-up assessment. |
Baseline, immediately after the 6-day intervention, and 1-month follow-up
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Change in Rumination
기간: Baseline, immediately after the 6-day intervention, and 1-month follow-up
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Rumination will be assessed using the 22-item Ruminative Responses Scale (RRS). Each item is rated on a 4-point Likert scale (1-4), yielding a total score of 22-88. Higher scores indicate greater rumination severity (worse outcome). The outcome will be the change in total RRS score from baseline to each post-intervention and follow-up assessment. |
Baseline, immediately after the 6-day intervention, and 1-month follow-up
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Change in Habitual Thought Suppression
기간: Baseline, immediately after the 6-day intervention, and 1-month follow-up
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Habitual thought suppression and related unwanted-thought experiences will be assessed using the 15-item White Bear Suppression Inventory (WBSI). Each item is rated on a 5-point Likert scale (1-5), yielding a total score of 15-75. Higher scores indicate greater endorsement of habitual thought suppression and related unwanted-thought experiences, rather than better suppression ability. The outcome will be the change in total WBSI score from baseline to each post-intervention and follow-up assessment. |
Baseline, immediately after the 6-day intervention, and 1-month follow-up
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Change in Repetitive Negative Thinking
기간: Baseline, immediately after the 6-day intervention, and 1-month follow-up
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Repetitive negative thinking will be assessed using the 15-item Perseverative Thinking Questionnaire (PTQ). Each item is rated on a 5-point Likert scale (0-4), yielding a total score of 0-60. Higher scores indicate more severe repetitive negative thinking (worse outcome). The outcome will be the change in total PTQ score from baseline to each post-intervention and follow-up assessment. |
Baseline, immediately after the 6-day intervention, and 1-month follow-up
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Change in Obsessive-Compulsive Symptom Severity
기간: Baseline, immediately after the 6-day intervention, and 1-month follow-up
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Obsessive-compulsive symptom severity will be assessed using the 10-item Yale-Brown Obsessive Compulsive Scale (Y-BOCS) in participants for whom this assessment is applicable. Each item is rated on a 5-point scale (0-4), yielding a total score of 0-40. Higher scores indicate greater obsessive-compulsive symptom severity (worse outcome). The outcome will be the change in total Y-BOCS score from baseline to each subsequent assessment at which the scale is administered. |
Baseline, immediately after the 6-day intervention, and 1-month follow-up
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Change in Obsessive-Compulsive Symptoms
기간: Baseline, immediately after the 6-day intervention, and 1-month follow-up
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Obsessive-compulsive symptoms will be assessed using the 18-item Obsessive-Compulsive Inventory-Revised (OCI-R) in participants for whom this assessment is applicable. Each item is rated on a 5-point Likert scale (0-4), yielding a total score of 0-72. Higher scores indicate greater obsessive-compulsive symptom severity (worse outcome). The outcome will be the change in total OCI-R score from baseline to each subsequent assessment at which the scale is administered. |
Baseline, immediately after the 6-day intervention, and 1-month follow-up
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Change in PTSD Symptom Severity
기간: Baseline, immediately after the 6-day intervention, and 1-month follow-up
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Post-traumatic stress symptoms will be assessed using the 20-item PTSD Checklist for DSM-5 (PCL-5) in participants for whom this assessment is applicable. Each item is rated on a 5-point Likert scale (0-4), yielding a total score of 0-80. Higher scores indicate greater PTSD symptom severity (worse outcome). The outcome will be the change in total PCL-5 score from baseline to each subsequent assessment at which the scale is administered. |
Baseline, immediately after the 6-day intervention, and 1-month follow-up
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Change in Resting-State EEG Theta-Band Power Spectral Density
기간: Baseline and immediately after the six-day intervention.
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Resting-state electroencephalography (EEG) will be used to quantify theta-band (4-8 Hz) power spectral density (PSD) at baseline and immediately after the six-day intervention. PSD will be estimated from resting-state EEG recordings using the prespecified spectral estimation procedure. Theta-band PSD will be calculated as the mean PSD across frequencies from 4 to 8 Hz within the prespecified EEG electrodes or regions of interest. The outcome will be the change in mean theta-band PSD from baseline to post-intervention, expressed in microvolts squared per hertz (µV²/Hz). Higher values indicate greater theta-band spectral power density. |
Baseline and immediately after the six-day intervention.
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Change in Resting-State EEG Beta-Band Power Spectral Density
기간: Baseline and immediately after the six-day intervention.
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Resting-state EEG will be used to quantify beta-band (13-30 Hz) power spectral density (PSD) at baseline and immediately after the six-day intervention. PSD will be estimated from resting-state EEG recordings using the prespecified spectral estimation procedure. Beta-band PSD will be calculated as the mean PSD across frequencies from 13 to 30 Hz within the prespecified EEG electrodes or regions of interest. The outcome will be the change in mean beta-band PSD from baseline to post-intervention, expressed in microvolts squared per hertz (µV²/Hz). Higher values indicate greater beta-band spectral power density. |
Baseline and immediately after the six-day intervention.
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Change in Resting-State Functional Connectivity Between the Hippocampus and Prefrontal Cortex
기간: Baseline and immediately after the six-day intervention.
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Resting-state functional magnetic resonance imaging (rs-fMRI) will be used to quantify functional connectivity between the prespecified hippocampal seed region and prefrontal cortical target region at baseline and immediately after the six-day intervention. For each participant, the blood-oxygen-level-dependent (BOLD) time series will be extracted from the hippocampal seed and the prespecified prefrontal target region. Functional connectivity will be calculated as the Pearson correlation coefficient between the two regional time series and transformed using Fisher's r-to-z transformation. The outcome will be the change in the Fisher z-transformed functional connectivity value from baseline to post-intervention. Higher values indicate stronger positive functional connectivity between the specified regions. |
Baseline and immediately after the six-day intervention.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Statistical Analysis
기간: Baseline, immediately after the 6-day intervention, 1-month follow-up, and 6-month follow-up
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Longitudinal changes in clinical and behavioral questionnaire scores will be analyzed using linear mixed-effects models (LMMs). Fixed effects will include intervention group, assessment time, and the group-by-time interaction. A participant-level random intercept will be included to account for within-participant correlation across repeated assessments. The primary group comparisons will focus on differences in change over time between the five randomized intervention groups. Model estimates, effect sizes, and 95% confidence intervals will be reported. Model assumptions and the handling of missing data will be evaluated according to the prespecified statistical analysis plan. |
Baseline, immediately after the 6-day intervention, 1-month follow-up, and 6-month follow-up
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: chunyan zhu, PhD, Anhui Medical University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 81250854
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data (IPD) will not be shared publicly because the study involves sensitive clinical information from individuals with psychiatric disorders, including symptom assessments, trauma-related information, neurophysiological data, and neuroimaging data. Sharing individual-level data may pose potential risks to participant privacy and confidentiality. All data will be managed according to the approved ethical protocol and applicable regulations. De-identified aggregated results will be reported in scientific publications, while access to individual-level data will not be provided as part of this study.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .