MBCT for Psoriasis Patients With Anxiety and Depression
Primary Purpose
Psoriasis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
mindfulness-based cognitive therapy (MBCT)
Antipsoriatic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- the age ranged from 18 to 70 years old
- fulfilled the Classification Criteria for Psoriasis
- the score of the SDS > 50 and / or SAS >50
- Participant has normal or corrected to normal vision and hearing
- Participant is willing and able to give informed consent for participation in the study.
Exclusion Criteria:
- Participant has insufficient manual dexterity for the computerized tasks
- severe systemic diseases
- patients with severe mental illness or taking psychotic drugs
- Pregnancy
- No access to the internet
Sites / Locations
- First Affiliated Hospital of Xi'an Jiaotong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Participants received MBCT once a week for 8 weeks
Active comparator
Arm Description
Participants received MBCT once a week for 8 weeks. At the same time, the drug therapy for psoriasis was used .
Only the drug therapy for psoriasis was used .
Outcomes
Primary Outcome Measures
Change from Baseline on the Psoriasis Area and Severity Index (PASI)
PASI a measurement that combines severity of lesions and the area affected in one score that ranges from 0 to 72 .
Change from Baseline on the Dermatology Life Quality Index (DLQI)
The DLQI is a 10-item questionnaire measuring the effect of dermatological diseases on patients over the last week. The DLQI total score is the sum of each individual item score and ranges from 0 or 1 to 30 .
Change from Baseline on the Self-rating Depression Scale (SDS)
In the main component of the SDS , patients are asked 20 questions about Mental and physical feelings of emotional experience, and the patients determine the quality of emotion by selecting one of the options: Occasionally=1, sometimes=2, often=3, and continuously=4.
Change from Baseline on the Self-rating Anxiety Scale (SAS).
In the main component of the SAS , patients are asked 20 questions about Mental and physical feelings of emotional experience, and the patients determine the quality of emotion by selecting one of the options: Occasionally=1, sometimes=2, often=3, and continuously=4. The total score is multiplied by an integer of 1.25 to get the standard score.
Secondary Outcome Measures
Itch perception
Questions regarding situations in which the itch is especially bad (multiple choice options regarding day time, daily situations); objective assessment in which respondents are asked to select answers from the choices offered as a list
Hours missing at work
Approximate average hours missing at work due to itch per week from last visit.
Helpfulness of common itch therapies
Questions regarding helpfulness of common itch therapies.
Full Information
NCT ID
NCT05010044
First Posted
July 14, 2021
Last Updated
August 17, 2021
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT05010044
Brief Title
MBCT for Psoriasis Patients With Anxiety and Depression
Official Title
Mindfulness-based Cognitive Therapy for Psoriasis Patients With Anxiety and Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong 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
This study investigates the effectiveness of a 24-week mindfulness intervention in reducing symptoms in psoriasis patients with anxiety and depression.
Detailed Description
An adapted MBCT intervention will be offered to people with psoriasis with depression and/or anxiety. 8-week long MBCT therapy will be held between August 2021 and Jan 2022, based on the adapted protocol. The MBCT intervention will consist of 30-minute weekly groups focused on teaching mindfulness techniques and ways to recognize cognitive patterns that can increase anxiety and/or depression. Participants will be recruited from the community, according to the eligibility criteria detailed below. For all participants, anxiety and/or depressive symptom severity(SAS/SDS), PASI,DLQI,(as measured with standardized, validated scales) will be compared baseline and weeks 2;4;8;12;16;20;24. Itch intensity ,itch perception ,quality of sleep, hours missing at work ,helpfulness of common itch therapies serve as the secondary outcome, using a paired t-test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants received MBCT once a week for 8 weeks
Arm Type
Experimental
Arm Description
Participants received MBCT once a week for 8 weeks. At the same time, the drug therapy for psoriasis was used .
Arm Title
Active comparator
Arm Type
Active Comparator
Arm Description
Only the drug therapy for psoriasis was used .
Intervention Type
Behavioral
Intervention Name(s)
mindfulness-based cognitive therapy (MBCT)
Intervention Description
Mindfulness- Based Cognitive Therapy (MBCT) It involves practicing to be present 'in the moment' and an attitude of non- judgmental acceptance with the aim to maintain awareness, disengaging oneself from strong attachment and thereby developing a greater sense of emotional balance and well-being.
Intervention Type
Other
Intervention Name(s)
Antipsoriatic treatment
Intervention Description
The routine drug therapy for psoriasis.
Primary Outcome Measure Information:
Title
Change from Baseline on the Psoriasis Area and Severity Index (PASI)
Description
PASI a measurement that combines severity of lesions and the area affected in one score that ranges from 0 to 72 .
Time Frame
Baseline and Week 2;4;8;12;16;20;24
Title
Change from Baseline on the Dermatology Life Quality Index (DLQI)
Description
The DLQI is a 10-item questionnaire measuring the effect of dermatological diseases on patients over the last week. The DLQI total score is the sum of each individual item score and ranges from 0 or 1 to 30 .
Time Frame
Baseline and Week 2;4;8;12;16;20;24
Title
Change from Baseline on the Self-rating Depression Scale (SDS)
Description
In the main component of the SDS , patients are asked 20 questions about Mental and physical feelings of emotional experience, and the patients determine the quality of emotion by selecting one of the options: Occasionally=1, sometimes=2, often=3, and continuously=4.
Time Frame
Baseline and Week 2;4;8;12;16;20;24
Title
Change from Baseline on the Self-rating Anxiety Scale (SAS).
Description
In the main component of the SAS , patients are asked 20 questions about Mental and physical feelings of emotional experience, and the patients determine the quality of emotion by selecting one of the options: Occasionally=1, sometimes=2, often=3, and continuously=4. The total score is multiplied by an integer of 1.25 to get the standard score.
Time Frame
Baseline and Week 2;4;8;12;16;20;24
Secondary Outcome Measure Information:
Title
Itch perception
Description
Questions regarding situations in which the itch is especially bad (multiple choice options regarding day time, daily situations); objective assessment in which respondents are asked to select answers from the choices offered as a list
Time Frame
Baseline
Title
Hours missing at work
Description
Approximate average hours missing at work due to itch per week from last visit.
Time Frame
Baseline and Week 2;4;8;12;16;20;24
Title
Helpfulness of common itch therapies
Description
Questions regarding helpfulness of common itch therapies.
Time Frame
Baseline and Week 2;4;8;12;16;20;24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the age ranged from 18 to 70 years old
fulfilled the Classification Criteria for Psoriasis
the score of the SDS > 50 and / or SAS >50
Participant has normal or corrected to normal vision and hearing
Participant is willing and able to give informed consent for participation in the study.
Exclusion Criteria:
Participant has insufficient manual dexterity for the computerized tasks
severe systemic diseases
patients with severe mental illness or taking psychotic drugs
Pregnancy
No access to the internet
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhou, professor
Phone
0086-13379007762
Email
yanzhou7798@xjtu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhao
Phone
0086-18626973745
Email
2130315198@stu.xjtu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zhou, professor
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhou, professor
Phone
0086-13379007762
Email
yanzhou7798@xjtu.edu.cn
12. IPD Sharing Statement
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MBCT for Psoriasis Patients With Anxiety and Depression
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