Clinical trial NCT05502848: The Effect of Intervention and Mechanism of ICBT on Chronic Itching in Patients With Atopic Dermatitis
Official title: The Effect of Intervention and Mechanism of Internet Cognitive Behavioral Therapy on Chronic Itching in Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Internet Cognitive Behavioral Therapy
Chronic Itching
Functional MRI
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* meet the diagnostic criteria of AD
* more than moderate AD symptoms, with patient-oriented eczema measurement score (POEM) ≥ 8 points, atopic dermatitis score (SCORAD) objective signs score \> 15 points
* aged 18-45 years
* right-handed
* education years ≥ 6 years and access to the Internet
* patients must stop all immunosuppressive drugs at least 10 days before the study to avoid potential itching inhibition
* voluntarily participate in this study, and have fully understood the purpose, methods, procedures, possible discomfort and risks of the experiment, and signed informed consent.

Exclusion Criteria:

* current or previous severe physical and neurological diseases
* chronic oral benzodiazepines and other drugs
* recent or ongoing psychotherapy
* psoriasis
* recent ultraviolet therapy or immunosuppressive drug therapy for AD
* patients at serious risk of suicide
* claustrophobia or metal implants in the body. (Considering the effect of age on MRI results, only patients aged 18-45 years were included in this study. After enrollment, conventional treatment such as topical glucocorticoids was not affected by this study, but the two groups were matched in the selection of conventional treatment drugs. On this basis, patients were randomly divided into ICBT intervention group or conventional treatment control group)

Primary outcomes:
measure: Change from Baseline on the Patient Oriented Eczema Measure(POEM)
timeFrame: Baseline and Week 2;4;8 and Month 6;12
measure: Change from Baseline on the Scoring Atopic Dermatitis Index(SCORAD)
timeFrame: Baseline and Week 2;4;8 and Month 6;12
measure: Change from Baseline on scratching times
timeFrame: Baseline and Week 2;4;8 and Month 6;12
measure: Change from Baseline on the Itchy Quality of Life(ItchyQoL)
timeFrame: Baseline and Month 6
measure: Change from Baseline on structural MRI (3D; DTI) and functional MRI (resting state; task state)
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: Change from Baseline on the 9-item Patient Health Questionnaire(PHQ-9)
timeFrame: Baseline and Week 2;4;8 and Month 6;12
measure: Change from Baseline on the Generalized Anxiety Disorder-7(GAD-7)
timeFrame: Baseline and Week 2;4;8 and Month 6;12
measure: Change from Baseline on the Athens Insomnia ScaleL(AIS)
timeFrame: Baseline and Month 6
measure: Change from Baseline on the Dysfunctional Attitude Scale(DAS)
timeFrame: Baseline and Month 6
measure: Change from Baseline on the blood samples
timeFrame: Baseline and Month 6
measure: Change from Baseline on Attention Network Test (ANT)
timeFrame: Baseline and Month 6
measure: Change from Baseline on THINC-integrated tool
timeFrame: Baseline and Month 6
measure: Change from Baseline on the Chinese Perceived Stress Scale (CPSS)
timeFrame: Baseline and Month 6
Other outcomes:
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