Clinical trial NCT05010044: MBCT for Psoriasis Patients With Anxiety and Depression
Official title: Mindfulness-based Cognitive Therapy for Psoriasis Patients With Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline on the Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline and Week 2;4;8;12;16;20;24
measure: Change from Baseline on the Dermatology Life Quality Index (DLQI)
timeFrame: Baseline and Week 2;4;8;12;16;20;24
measure: Change from Baseline on the Self-rating Depression Scale (SDS)
timeFrame: Baseline and Week 2;4;8;12;16;20;24
measure: Change from Baseline on the Self-rating Anxiety Scale (SAS).
timeFrame: Baseline and Week 2;4;8;12;16;20;24
Secondary outcomes:
measure: Itch perception
timeFrame: Baseline
measure: Hours missing at work
timeFrame: Baseline and Week 2;4;8;12;16;20;24
measure: Helpfulness of common itch therapies
timeFrame: Baseline and Week 2;4;8;12;16;20;24
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yan Zhou, professor
role: PRINCIPAL_INVESTIGATOR
References: