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Atopic DermatitisNCT05502848

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

A study testing Internet Cognitive Behavior Therapy in people with Atopic Dermatitis, run by Xiangya Hospital of Central South University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis
What is being tested?
Internet Cognitive Behavior Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
No sites listed yet
Study dates
20 Aug 2022to 31 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

About this study

Official title: The Effect of Intervention and Mechanism of Internet Cognitive Behavioral Therapy on Chronic Itching in Patients With Atopic Dermatitis

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.

Read the 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.

Being tested
Internet Cognitive Behavior Therapy
Keywords
Atopic Dermatitis, Internet Cognitive Behavioral Therapy, Chronic Itching, Functional MRI
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet Cognitive Behavior TherapyBehavioural

    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

Study groups in NCT05502848
Study groupRoleWhat they receive
AD patients treated with ICBTExperimentalNot described
Receives: Behavioral: Internet Cognitive Behavior Therapy
AD patients receiving regular treatmentNo interventionNot described
Healthy ControlsNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

  3. Change from Baseline on scratching times

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

  4. 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

    Measured: Baseline and Month 6

  5. 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

    Measured: Baseline and Month 6

Secondary outcomes (8)

  1. 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

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

  2. 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

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

  3. Change from Baseline on the Athens Insomnia ScaleL(AIS)

    Athens Insomnia ScaleL (AIS): It is used to evaluate the sleep status of subjects

    Measured: Baseline and Month 6

  4. 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.

    Measured: Baseline and Month 6

  5. 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

    Measured: Baseline and Month 6

  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).

    Measured: Baseline and Month 6

  7. 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.

    Measured: Baseline and Month 6

  8. 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

    Measured: Baseline and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2022
  2. Study start20 Aug 2022 (estimated)
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05502848
Sponsor's protocol ID
2209090555263
Status last verified
Jul 2022
First submitted
1 Aug 2022
Last updated
16 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Internet Cognitive Behavior Therapy in people with Atopic Dermatitis, run by Xiangya Hospital of Central South University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline on the Patient Oriented Eczema Measure(POEM) (time frame: Baseline and Week 2;4;8 and Month 6;12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05502848.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.

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