The Effect of Intervention and Mechanism of ICBT on Chronic Itching in Patients With Atopic Dermatitis

NCT05502848 | Unknown

• 1 other identifier: 2209090555263
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Internet Cognitive Behavioral Therapy; Chronic Itching; Functional MRI

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (8)

• Change from Baseline on the 9-item Patient Health Questionnaire(PHQ-9)

  Baseline and Week 2;4;8 and Month 6;12

• Change from Baseline on the Generalized Anxiety Disorder-7(GAD-7)

  Baseline and Week 2;4;8 and Month 6;12

• Change from Baseline on the Athens Insomnia ScaleL(AIS)

  Baseline and Month 6

• Change from Baseline on the Dysfunctional Attitude Scale(DAS)

  Baseline and Month 6

• Change from Baseline on the blood samples

  Baseline and Month 6

Study Arms (3)

AD patients treated with ICBT

EXPERIMENTAL

Behavioral: Internet Cognitive Behavior Therapy

AD patients receiving regular treatment

NO INTERVENTION

Healthy Controls

NO INTERVENTION

Interventions

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

AD patients treated with ICBT

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 16, 2022
• Study Start: August 20, 2022
• Primary Completion: June 1, 2025
• Study Completion: October 31, 2025
• Last Updated: August 16, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share