Ignite Creation Date:
2024-05-06 @ 5:59 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05502848
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-08-16
First Post:
2022-08-01
Brief Title:
The Effect of Intervention and Mechanism of ICBT on Chronic Itching in Patients With Atopic Dermatitis
Sponsor:
Xiangya Hospital of Central South University
Organization:
Xiangya Hospital of Central South University
Study Overview
Official Title:
The Effect of Intervention and Mechanism of Internet Cognitive Behavioral Therapy on Chronic Itching in Patients With Atopic Dermatitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None