MBCT for Psoriasis Patients With Anxiety and Depression

NCT ID: NCT05010044

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2022-01-31

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.

Conditions

Psoriasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants received MBCT once a week for 8 weeks

Participants received MBCT once a week for 8 weeks. At the same time, the drug therapy for psoriasis was used .

Group Type: EXPERIMENTAL

mindfulness-based cognitive therapy (MBCT)

Intervention Type: BEHAVIORAL

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.

Antipsoriatic treatment

Intervention Type: OTHER

The routine drug therapy for psoriasis.

Active comparator

Only the drug therapy for psoriasis was used .

Group Type: ACTIVE_COMPARATOR

Antipsoriatic treatment

Intervention Type: OTHER

The routine drug therapy for psoriasis.

Interventions

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.

Intervention Type: BEHAVIORAL

Antipsoriatic treatment

The routine drug therapy for psoriasis.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Zhou, professor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Yan Zhou, professor

Role: CONTACT

yanzhou7798@xjtu.edu.cn

0086-13379007762

Yan Zhao

Role: CONTACT

2130315198@stu.xjtu.edu.cn

0086-18626973745

Facility Contacts

Yan Zhou, professor

Role: primary

yanzhou7798@xjtu.edu.cn

0086-13379007762

Other Identifiers

XJTU1AF-CRF-2019-027

Identifier Type: -

Identifier Source: org_study_id