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MBCT for Psoriasis Patients With Anxiety and Depression

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05010044
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 First Affiliated Hospital Xi'an Jiaotong University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Yan Zhou, professor
Principal Investigator Affiliation First Affiliated Hospital Xi'an Jiaotong University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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 .

Active Comparator: Active comparator

Only the drug therapy for psoriasis was used .

Interventions

Behavioral: - 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.

Other: - Antipsoriatic treatment

The routine drug therapy for psoriasis.

Contact a Trial Team

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International Sites

Xi'an, Shaanxi, China

Status

Address

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061

Site Contact

Yan Zhou, professor

yanzhou7798@xjtu.edu.cn

0086-13379007762

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