MBCT for Psoriasis Patients With Anxiety and Depression

Psoriasis Clinical Trial

Official title:

Mindfulness-based Cognitive Therapy for Psoriasis Patients With Anxiety and Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05010044
• Other study ID #: XJTU1AF-CRF-2019-027
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: January 2022

Study information

• Verified date: July 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yan Zhou, professor
• Phone: 0086-13379007762
• Email: yanzhou7798[@]xjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates the effectiveness of a 24-week mindfulness intervention in reducing symptoms in psoriasis patients with anxiety and depression.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Behavioral:
• mindfulness-based cognitive therapy (MBCT)
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.

Other:
• Antipsoriatic treatment
The routine drug therapy for psoriasis.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	Baseline and Week 2;4;8;12;16;20;24
Primary	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 .	Baseline and Week 2;4;8;12;16;20;24
Primary	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.	Baseline and Week 2;4;8;12;16;20;24
Primary	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.	Baseline and Week 2;4;8;12;16;20;24
Secondary	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	Baseline
Secondary	Hours missing at work	Approximate average hours missing at work due to itch per week from last visit.	Baseline and Week 2;4;8;12;16;20;24
Secondary	Helpfulness of common itch therapies	Questions regarding helpfulness of common itch therapies.	Baseline and Week 2;4;8;12;16;20;24