MBCT for Psoriasis Patients With Anxiety and Depression

NCT05010044 | Unknown

• 1 other identifier: XJTU1AF-CRF-2019-027
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Itch perception

  Baseline

• Hours missing at work

  Baseline and Week 2;4;8;12;16;20;24

• Helpfulness of common itch therapies

  Baseline and Week 2;4;8;12;16;20;24

Study Arms (2)

Participants received MBCT once a week for 8 weeks

EXPERIMENTAL

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

Behavioral: mindfulness-based cognitive therapy (MBCT); Other: Antipsoriatic treatment

Active comparator

ACTIVE COMPARATOR

Only the drug therapy for psoriasis was used .

Other: Antipsoriatic treatment

Interventions

mindfulness-based cognitive therapy (MBCT) 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.

Participants received MBCT once a week for 8 weeks

Antipsoriatic treatment OTHER

The routine drug therapy for psoriasis.

Active comparator; Participants received MBCT once a week for 8 weeks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Yan Zhou, professor

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Zhou, professor

CONTACT

0086-13379007762; yanzhou7798@xjtu.edu.cn

Yan Zhao

CONTACT

0086-18626973745; 2130315198@stu.xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 18, 2021
• Study Start: August 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: August 18, 2021

Record last verified: 2021-07

Locations

CN (1)