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Objectives: The study subjects were 180 healthy people from the dermatology clinic of Xiangya Hospital of Central South University and the surroundingcommunity, including 120 AD patients (60 in the ICBT treatment group and 60 in the control group) and 60 healthy controls.
Methodology: After obtaining the informed consent of the subjects, the general condition and clinical symptoms of the subjects were assessed, the cognitive and psychological characteristics of the subjects who met the inclusion were assessed, multimodality MRI was scanned and blood and saliva samples were collected. The same assessments and data collection were performed with healthy controls matched for age, sex, and years of education in the AD patient group. AD patients were randomly assigned to the ICBT intervention group (n = 60) by a random number table and immediately started ICBT adjuvant therapy, or the control group (n = 60) for conventional therapy. Clinical symptoms and cognitive psychological characteristics of AD patients were assessed at the end of 2 weeks, 4 weeks, 8 weeks, 6 months and 12 months of ICBT treatment, and cognitive behavioral task measurements, multimodality magnetic resonance scans, blood and saliva samples will be performed again at the follow-up time point at the end of 6 months. Healthy controls (60) will also undergo a full set of follow-up assessments again after 6 months.
Atopic dermatitis (AD) is a common chronic inflammatory skin disease accompanied by severe itching, leading to poor patient-reported satisfaction. Previous studies have found a mutually reinforcing relationship between stress, depression, anxiety and itching in AD, which is mediated by cognitive dysfunction. Patients with AD show elevated activation in the key regions of cognitive control network, such as anterior cingulate cortex and dorsolateral prefrontal cortex, when facing itching stimulus, which are positively associated with the severity of itching. Based on these findings, we propose a hypothesis that "dysfunction of cognitive control network may underlie the increased sensitivity to itching in AD". To test the hypothesis, we will conduct a randomized controlled study on the effectiveness of Internet cognitive behavior therapy (ICBT) for AD. Using the multi-modal magnetic resonance imaging technology, we will compare the brain imaging characteristics in AD patients before and after treatment with ICBT. We will further investigate the factors associated with response to ICBT treatment and the underlying mechanisms of the treatment effect of ICBT, expecting to improve long-term treatment outcomes of AD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD patients treated with ICBT | Experimental |
| |
| AD patients receiving regular treatment | No Intervention | ||
| Healthy Controls | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet Cognitive Behavior Therapy | Behavioral | ICBT helps change patterns of thinking (cognitions) and behaviors of psychological distress, including relaxation, stress management, while using ICBT can increase personal tolerance for negative thoughts and negative emotions, help patients reduce negative perception of the disease due to long-term recurrent itching, and break the vicious cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline on the Patient Oriented Eczema Measure(POEM) | Patient Oriented Eczema Measure (POEM) is divided into 7 questions, with a total score of 28 points, and treatment response is defined as a reduction of POEM of greater than 4 points | Baseline and Week 2;4;8 and Month 6;12 |
| Change from Baseline on the Scoring Atopic Dermatitis Index(SCORAD) | Scoring Atopic Dermatitis Index (SCORAD), which consists of objective signs (lesion area, lesion severity) and subjective symptoms as well as a visual analogue scale assessing pruritus and sleep impact. | Baseline and Week 2;4;8 and Month 6;12 |
| Change from Baseline on scratching times | Baseline and Week 2;4;8 and Month 6;12 | |
| Change from Baseline on the Itchy Quality of Life(ItchyQoL) | Itchy Quality of Life (Itchy QoL): assess the impact of pruritus symptoms on quality of life. The Chinese version of Itchy Quality of Life (QOL) consists of 22 items, including three dimensions of symptoms, mood and functional activities, with good reliability and validity | Baseline and Month 6 |
| Change from Baseline on structural MRI (3D; DTI) and functional MRI (resting state; task state) | MRI data were acquired on a Siemens scanner using a 64-channel head coil,We used structural MRI to measure voxel-base morphometry analysis of brain regions as well as changes in DTI connectivity activity. We will compare structural and functional magnetic resonance differences between AD and healthy controls, structural magnetic resonance and functional magnetic resonance differences between AD after 6 months of ICBT therapy, AD control and baseline, and differences between AD and healthy controls after 6 months | Baseline and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline on the 9-item Patient Health Questionnaire(PHQ-9) | 9-item Patient Health Questionnaire (PHQ-9): used to assess severity of depression | Baseline and Week 2;4;8 and Month 6;12 |
| Change from Baseline on the Generalized Anxiety Disorder-7(GAD-7) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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|
7-item Generalized Anxiety Disorder-7 (GAD-7): used to assess anxiety severity in subjects |
| Baseline and Week 2;4;8 and Month 6;12 |
| Change from Baseline on the Athens Insomnia ScaleL(AIS) | Athens Insomnia ScaleL (AIS): It is used to evaluate the sleep status of subjects | Baseline and Month 6 |
| Change from Baseline on the Dysfunctional Attitude Scale(DAS) | Dysfunctional Attitude Scale (DAS): a total of 40 items, assess the subjective cognitive attitude of subjects, assess the subjective cognitive attitude of subjects to self, external events and negative perceptions of the future, including vulnerability, attraction and rejection, perfection, compulsion, praise seeking, dependence, autonomy attitude and cognitive philosophy. The higher the score, the stronger the negative understanding of patients. | Baseline and Month 6 |
| Change from Baseline on the blood samples | Cortisol level (ng/ml), ATP(nmmol/L), highly sensitive C-reactive protein (hs-CRP), Monocyte Chemoattractant Protein 1 (MCP1), Type 2 inflammation: interleukins (IL)-4, 5, 13, 31, Type 1 inflammation: Tumor necrosis factor(TNF), Interferon(IFN)γ, Type 17-22 inflammation: IL-12, IL-23, IL-17a, IL-22, Innate inflammation: thymic stromal lymphopoietin(TSLP), IL-25, IL-33, IL-1b, IL-1a, IL-18 | Baseline and Month 6 |
| Change from Baseline on Attention Network Test (ANT) | Attention Network Test (ANT) experimental paradigm: This paradigm can effectively measure the efficiency of three core components of attention network (alerting, orienting and executive function). | Baseline and Month 6 |
| Change from Baseline on THINC-integrated tool | THINC-it tool (THINC - integrated tool) cognitive test: It is a digital cognitive assessment screening tool that integrates a series of assessments: patients with cognitive deficits ask, this questionnaire is a subjective assessment questionnaire of patients' cognitive function. | Baseline and Month 6 |
| Change from Baseline on the Chinese Perceived Stress Scale (CPSS) | The Chinese Perceived Stress Scale (CPSS) assesses individual stress in subjects. This scale asks how you have been feeling and thinking in the last month, with higher scores indicating greater stress | Baseline and Month 6 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |