MBCT for Psoriasis Patients With Anxiety and Depression

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

Detailed Description
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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.

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

Conditions
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Psoriasis

Intervention / Treatment
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* Behavioral: mindfulness-based cognitive therapy (MBCT)
* Other: Antipsoriatic treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants received MBCT once a week for 8 weeks<br>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)<br>* 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.<br>Other: Antipsoriatic treatment<br>* The routine drug therapy for psoriasis.<br>|
| Active Comparator: Active comparator<br>Only the drug therapy for psoriasis was used . | Other: Antipsoriatic treatment<br>* The routine drug therapy for psoriasis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Helpfulness of common itch therapies | Questions regarding helpfulness of common itch therapies. | Baseline and Week 2;4;8;12;16;20;24 |