PsoriasisNCT05010044
MBCT for Psoriasis Patients With Anxiety and Depression
A study testing mindfulness-based cognitive therapy (MBCT) and Antipsoriatic treatment in people with Psoriasis, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This study investigates the effectiveness of a 24-week mindfulness intervention in reducing symptoms in psoriasis patients with anxiety and depression. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- mindfulness-based cognitive therapy (MBCT) and Antipsoriatic treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2021to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yan Zhou, professor, 0086-13379007762, yanzhou7798@xjtu.edu.cn
About this study
Official title: Mindfulness-based Cognitive Therapy for Psoriasis Patients With Anxiety and Depression
This study investigates the effectiveness of a 24-week mindfulness intervention in reducing symptoms in psoriasis patients with anxiety and depression.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- mindfulness-based cognitive therapy (MBCT), Antipsoriatic treatment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based cognitive therapy (MBCT)Behavioural
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.
Antipsoriatic treatmentOther
The routine drug therapy for psoriasis.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Behavioral: mindfulness-based cognitive therapy (MBCT); Other: Antipsoriatic treatment |
| Active comparator | Active comparator | Only the drug therapy for psoriasis was used . Receives: Other: Antipsoriatic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: Baseline and Week 2;4;8;12;16;20;24
Secondary outcomes (3)
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
Measured: Baseline
Hours missing at work
Approximate average hours missing at work due to itch per week from last visit.
Measured: Baseline and Week 2;4;8;12;16;20;24
Helpfulness of common itch therapies
Questions regarding helpfulness of common itch therapies.
Measured: Baseline and Week 2;4;8;12;16;20;24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study startAug 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Zhou, professor, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010044
- Sponsor's protocol ID
- XJTU1AF-CRF-2019-027
- Status last verified
- Jul 2021
- First submitted
- 14 Jul 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Cognitive Therapy for Psoriasis Patients With Anxiety and Depression
- ClinicalTrials.gov ID
- NCT05010044
- Acronym / sponsor ID
- XJTU1AF-CRF-2019-027
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants received MBCT once a week for 8 weeks | Experimental | Behavioral: mindfulness-based cognitive therapy (MBCT), Other: Antipsoriatic treatmentParticipants received MBCT once a week for 8 weeks. At the same time, the drug therapy for psoriasis was used . |
| Active comparator | Active comparator | Other: Antipsoriatic treatmentOnly the drug therapy for psoriasis was used . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Participants received MBCT once a week for 8 weeks |
| Antipsoriatic treatmentThe routine drug therapy for psoriasis. | Other | Active comparator, Participants received MBCT once a week for 8 weeks |
Primary outcome
Change from Baseline on the Psoriasis Area and Severity Index (PASI)
Time frame: 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 Dermatology Life Quality Index (DLQI)
Time frame: 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 Depression Scale (SDS)
Time frame: 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 Self-rating Anxiety Scale (SAS).
Time frame: 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.
3 secondary outcomes
Itch perception
Time frame: Baseline
Hours missing at work
Time frame: Baseline and Week 2;4;8;12;16;20;24
Helpfulness of common itch therapies
Time frame: Baseline and Week 2;4;8;12;16;20;24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Zhou, professor principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based cognitive therapy (MBCT) and Antipsoriatic treatment in people with Psoriasis, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Zhou, professor (0086-13379007762, yanzhou7798@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline on the Psoriasis Area and Severity Index (PASI) (time frame: Baseline and Week 2;4;8;12;16;20;24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.