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MBCT for Psoriasis Patients With Anxiety and Depression

Not Applicable
Conditions
Psoriasis
Interventions
Behavioral: mindfulness-based cognitive therapy (MBCT)
Other: Antipsoriatic treatment
Registration Number
NCT05010044
Lead Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Participants received MBCT once a week for 8 weeksAntipsoriatic treatmentParticipants received MBCT once a week for 8 weeks. At the same time, the drug therapy for psoriasis was used .
Participants received MBCT once a week for 8 weeksmindfulness-based cognitive therapy (MBCT)Participants received MBCT once a week for 8 weeks. At the same time, the drug therapy for psoriasis was used .
Active comparatorAntipsoriatic treatmentOnly the drug therapy for psoriasis was used .
Primary Outcome Measures
NameTimeMethod
Change from Baseline on the Psoriasis Area and Severity Index (PASI)Baseline and Week 2;4;8;12;16;20;24

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 Self-rating Depression Scale (SDS)Baseline and Week 2;4;8;12;16;20;24

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 Dermatology Life Quality Index (DLQI)Baseline and Week 2;4;8;12;16;20;24

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 Anxiety Scale (SAS).Baseline and Week 2;4;8;12;16;20;24

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
NameTimeMethod
Itch perceptionBaseline

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

Approximate average hours missing at work due to itch per week from last visit.

Helpfulness of common itch therapiesBaseline and Week 2;4;8;12;16;20;24

Questions regarding helpfulness of common itch therapies.

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University

🇨🇳

Xi'an, Shaanxi, China

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