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

Primary Purpose

Atopic Dermatitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet Cognitive Behavior Therapy
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Internet Cognitive Behavioral Therapy, Chronic Itching, Functional MRI

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    No Intervention

    No Intervention

    Arm Label

    AD patients treated with ICBT

    AD patients receiving regular treatment

    Healthy Controls

    Arm Description

    Outcomes

    Primary Outcome Measures

    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
    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.
    Change from Baseline on scratching times
    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
    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

    Secondary Outcome Measures

    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
    Change from Baseline on the Generalized Anxiety Disorder-7(GAD-7)
    7-item Generalized Anxiety Disorder-7 (GAD-7): used to assess anxiety severity in subjects
    Change from Baseline on the Athens Insomnia ScaleL(AIS)
    Athens Insomnia ScaleL (AIS): It is used to evaluate the sleep status of subjects
    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.
    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
    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).
    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.
    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

    Full Information

    First Posted
    August 1, 2022
    Last Updated
    August 14, 2022
    Sponsor
    Xiangya Hospital of Central South University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05502848
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 20, 2022 (Anticipated)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    October 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Xiangya Hospital of Central South University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atopic Dermatitis
    Keywords
    Atopic Dermatitis, Internet Cognitive Behavioral Therapy, Chronic Itching, Functional MRI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AD patients treated with ICBT
    Arm Type
    Experimental
    Arm Title
    AD patients receiving regular treatment
    Arm Type
    No Intervention
    Arm Title
    Healthy Controls
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Internet Cognitive Behavior Therapy
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change from Baseline on the Patient Oriented Eczema Measure(POEM)
    Description
    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
    Time Frame
    Baseline and Week 2;4;8 and Month 6;12
    Title
    Change from Baseline on the Scoring Atopic Dermatitis Index(SCORAD)
    Description
    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.
    Time Frame
    Baseline and Week 2;4;8 and Month 6;12
    Title
    Change from Baseline on scratching times
    Time Frame
    Baseline and Week 2;4;8 and Month 6;12
    Title
    Change from Baseline on the Itchy Quality of Life(ItchyQoL)
    Description
    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
    Time Frame
    Baseline and Month 6
    Title
    Change from Baseline on structural MRI (3D; DTI) and functional MRI (resting state; task state)
    Description
    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
    Time Frame
    Baseline and Month 6
    Secondary Outcome Measure Information:
    Title
    Change from Baseline on the 9-item Patient Health Questionnaire(PHQ-9)
    Description
    9-item Patient Health Questionnaire (PHQ-9): used to assess severity of depression
    Time Frame
    Baseline and Week 2;4;8 and Month 6;12
    Title
    Change from Baseline on the Generalized Anxiety Disorder-7(GAD-7)
    Description
    7-item Generalized Anxiety Disorder-7 (GAD-7): used to assess anxiety severity in subjects
    Time Frame
    Baseline and Week 2;4;8 and Month 6;12
    Title
    Change from Baseline on the Athens Insomnia ScaleL(AIS)
    Description
    Athens Insomnia ScaleL (AIS): It is used to evaluate the sleep status of subjects
    Time Frame
    Baseline and Month 6
    Title
    Change from Baseline on the Dysfunctional Attitude Scale(DAS)
    Description
    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.
    Time Frame
    Baseline and Month 6
    Title
    Change from Baseline on the blood samples
    Description
    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
    Time Frame
    Baseline and Month 6
    Title
    Change from Baseline on Attention Network Test (ANT)
    Description
    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).
    Time Frame
    Baseline and Month 6
    Title
    Change from Baseline on THINC-integrated tool
    Description
    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.
    Time Frame
    Baseline and Month 6
    Title
    Change from Baseline on the Chinese Perceived Stress Scale (CPSS)
    Description
    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
    Time Frame
    Baseline and Month 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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